Research done worldwide for MorSafe and Versator is listed below

 

Dr. Prakash Trivedi has described the In-bag Morcellation technique using MorSafe in “The journal of Obstetrics and Gynecology”. Dr. Trivedi has successfully removed twenty-one cases of fibroid as big as 1.4kg, and also a case of seven fibroids varying in size (4-7 cm) were morcellated using MorSafe for their retrieval. Dr. Trivedi claimed that the In-bag Morcellation using MorSafe handles the issue of ULMS (Uterine Leiomyosarcoma) and makes laparoscopic myomectomy and hysterectomy possible with fair safety. It drops down the risk of spread and quick recovery is possible for the patient. He also suggests that further study should be directed towards identifying the patient at high risk of ULMS prior to presumed leiomyoma resection in order to reduce the risk of inadvertent tumor Morcellation

Website: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4666217/

 

The article of “Laparoscopic Morcellation of Fibroid and Uterus In-bag” reported by Dr. Prakash Trivedi in the “Official Journal of The Federation of Obstetric and Gynecological Societies of India” introduced a technique of in-bag morcellation (MorSafe), thus avoiding the spillage of tissues in the peritoneal cavity and spread of an undiagnosed disease or cancer or sarcoma. It reduces the potential risk of open surgery and appears to handle the issue of ULMS and allows laparoscopic myomectomy and hysterectomy possible with safety.

Website: http://www.jogi.co.in/nov_dec_15/08_oa_Laparoscopic.html

 

The Journal of “Gynecology and Minimally Invasive Therapy” highlights the latest updates of Contained intra-abdominal morcellation techniques including the MorSafe which has achieved the CE certification. It states that the contained morcellation using a bag tends to improve the safety profile of power morcellation by reducing the risk of dissemination which further avoids the spillage of tissue within the abdominal cavity. The additional benefit of using a contained system aid the ease of removal of tissue fragments after morcellation and creates a safe operating field by keeping the bowels away from the morcellator. The material used to make the bag (MorSafe) is impermeable to tissue and liquids, translucent to allow visualization, large enough to accommodate the specimen and allow adequate insufflation to obtain a good operating field. The bag (MorSafe) allows the direct visualization of ongoing morcellation surgery with less operating time and minimal additional cost to the patient. The overall article states that contained morcellation using the bag (MorSafe) allows the surgeon to safely continue intra-abdominal manual or power morcellation without the absolute need for triage.

 

PubMed has published the abstract on MorSafe Tissue Morcellation Bag named as ‘’ Contained Morcellation for Laparoscopic Myomectomy Within a Specially Designed Bag.” It states that technique of contained Morcellation for laparoscopic myomectomy with the specially designed bag (MorSafe) was performed on ten patients between November 2014 and January 2015. The bag is basically made of medical grade a flexible plastic material. It's wider opening and narrow tail end allows easy accommodation of specimens up to 12cm in diameter. The mean operative time observed during surgery with MorSafe is comparatively well with no complications and no visual evidence of damage to the isolation bag. Hence it has been concluded that the In-bag Morcellation using MorSafe is a feasible technique which minimizes the risks and preserves the benefits of minimally invasive surgery.https://www.ncbi.nlm.nih.gov/pubmed/26260302

Website: https://www.ncbi.nlm.nih.gov/pubmed/26260302

 

Enes Taylan in his article “Contained Morcellation: Review of Current Methods and Future Directions” describes how new approaches of contained or in-bag Morcellation methods prevent the additional risk and complications associated with dissemination of tissues inside the abdominal cavity. Power Morcellation has been introduced to modern surgical practices which provide the opportunity to perform several minimally invasive procedures but it involves potential risks like inflammation, infection, unintentional dissemination of malignant cells etc. After two decades of surgical practice with power morcellators, FDA released a warning statement discouraging the use of Power morcellator in women based on safety concerns. To overcome the challenges and eliminate tissue dissemination during Morcellation researcher developed the “In-bag Morcellation technique” as contained Morcellation method for multiple laparoscopic surgeries. In developing phase of contained Morcellation, recently Paul et al. described the use of specially designed isolation bag (MorSafe; Veol Medical Technologies, Mumbai, India) for two port Morcellation method. This method facilitates less operative time with better efficiency and feasibility. In-bag Morcellation with Power morcellator surgery facilitates the advantages of less perioperative complications, better results, faster recovery and improve the quality of life.

Website: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5348539/

 

A review article reported by P.G. Paul includes the literature of contained tissue extraction and In-bag Morcellation with specially designed bags which offer an improvement over open Morcellation and allows more patients to have the benefits of minimally invasive surgery. Contained tissue extraction is one of the best alternatives to overcome the risk of power Morcellation by avoiding spillage in the peritoneal cavity and the wound site. The reported study by P.G. Paul describes the use of specially designed bag MorSafe Tissue Morcellation Bag of Veol Medical Technologies Pvt. Ltd., Mumbai, India. It is a retort-shaped bag made up of medical grade, biocompatible, flexible, transparent plastic material with wider opening (134mm) and tail end measures (4mm) in diameter, allowing the bag to easily accommodate a specimen of up to 12 cm in diameter. In comparison to others contained Morcellation the mean operative time observed for MorSafe was 117min with the additional operative time of 12.5min. Morcellation using MorSafe bag avoids the drawbacks of bag puncturing, allow safe removal of a large specimen in a contained fashion and offer an improvement over open Morcellation. Allow patients to have the benefits of minimally invasive surgery without the risk of open uncontained tissue Morcellation.

Website: https://www.ncbi.nlm.nih.gov/pubmed/26260302

 

"Journal of Minimally Invasive Gynecology (JMIG)" published new developments of minimally invasive techniques. Its 23rd volume which was published in Nov/Dec-2016 describes MorSafe as an isolation bag for power morcellation to avoid spreading myomas during morcellation. It has also mentioned that use of MorSafe bag during Morcellation is feasible and could potentially improve the safety of minimally invasive gynecologic surgery. It also contains the short overview of Morcellation process using MorSafe Tissue Morcellation Bag with Video.

Website: http://www.jmig.org/article/S1553-4650(16)30728-2/abstract

 

Morsafe is an isolation bag for power morcellation to avoid spreading myomas during morcellation. Using an isolation bag during morcellation is feasible and could potentially improve the safety of minimally invasive gynecologic surgery, the purpose of this video is to demonstrate the each step of bag morcellation during laproscopy.This technique involves inserting the isolation bag in to the abdomen, where tissue for removal was placed within the bag .The surgeon then pulled the opening of the bag to the exterior of the abdomen ,inflated the bag and fragmented the tissue within the bag to contain and remove it. After each procedure, the surgeon visually inspected the isolation bag for tears, as well as the abdominal and peritoneal cavities for tissue pieces left behind.

 

Uterine leiomyomata or Fibroids are the most common pelvic tumor experience in women. The incidence of uterine morcellation, the process of making a uterine specimen smaller for purposes of removal via minimally invasive approach, has increased for this reason .In this video we would like present a 48 year old women presented with heavy uterine bleeding.Transvaginal ultrasound revealed a bulky uterine more than 16 weeks of gestation with adenomyosis.Endometrial biopsy showed benign histologic architecture. Total laparoscopic hysterectomy was performed without any complication. Uterus was extracted by using contained power morcellation system within the insufflated Isolation bag (VersatorTMMorcellator and MorasfeTMBag. Veol Medical Technologies, Mumbai, India), She was discharged on postoperative 3rd day.In conclusion; Morcellation should be performed within a contained environment to minimize any potential tumor spread in the event of an undiagnosed malignancy.https://doi.org/10.1016/j.jmig.2017.08.534

Website: https://doi.org/10.1016/j.jmig.2017.08.534

 

Study Objective The main objective of this study was to describe the initial experience using contained power morcellation within a insufflated isolation bag (Morsafe Bag) to morcelate myoma or uterus.

Design Prospective study between September 2016 to April 2017.

Setting Private Practice

Patients We analyzed 15 consecutive patients submitted to laparoscopy for abdominal uterine bleeding and/or myomas.

Intervention All patients were submitted to myomectomy or hysterectomy. We used contained power morcellation within as insufflated isolation bag (Morsafe Bag) during the 15 Procedures. Measurements and Main Results: We analyzed the data of the 15 procedures performed. The mean age of patients were 35.8 (range 25-48) we performed 13 myomectomies and 2 hysterectomies. The main sizes of myomas were 5.6cm (range 4-11). The mean volume of uterus of both hysterectomies was 758cm3 .The mean time between the isolation of Morsafe bag and the start of the morcellation were 344 seconds. We tested all the 15 bags after the procedure filling them with water. We didn’t find any leakage.

CONCLUSION

Morsafe Bag is a useful tool to help gynecologist to keep performing myomectomies and hysterectomies without spreading any tissue in the abdominal cavity. Its additional advantage is to avoid accidents because after the insufflation of the bag the distance between the tissue to be morcellated and the abdominal organs become wider. The time between the insertion of the Morsafe Bag and the start of the morcellation did not compromise the total time of procedures. Contained power morcellation within an insufflated isolation bag will become a standard procedure in a near future.

Research done worldwide for In Bag Morcellation is listed below

Leal MA1, Piñera A, De Santiago J, Zapardiel I.

Abstract

In Apr 2014, the US Food and Drug Administration published a safety communication warning of the risk of an unsuspected uterine sarcoma being morcellated during a laparoscopic procedure and therefore advising against the use of power morcellation. These statements have encouraged the scientific community to look for new techniques that allows performing this procedure in a safer way, decreasing the risk of malignant dissemination thorough the abdominal cavity. We describe a new technique for power morcellation using a plastic bag through umbilicus using a latex glove and skin retractor as a single port device. This new procedure was performed in 4 women diagnosed with myomatous uterus. Median age was 40.5 years. No intraoperative complications, conversion to laparotomy or bag rupture occurred. Median surgical time was 195 min and median morcellation time was 48 min. Median in-hospital stay was 4.5 days. This new technique could be an acceptable and feasible alternative for specimen delivery during laparoscopic hysterectomy and myomectomy. However, it is still necessary to increase the number of procedures to assess its safety in case of uterine sarcoma.

Serur E1, Zambrano N1, Brown K1, Clemetson E1, Lakhi N2.

Abstract

STUDY OBJECTIVES - To describe a technique to manually morcellate large uteri within a polyurethane endoscopic bag at the time of laparoscopic hysterectomy, and report perioperative outcomes from our 5 years of experience.

STUDY DESIGN - Retrospective review of all consecutive hysterectomies with uterine weight > 500g performed between Jan 2010 and Dec 2014 in which the uterus was manually morcellated within an endoscopic bag by either an abdominal or vaginal approach (Canadian Task Force Classification Level III).

SETTING - Tertiary care academic medical center.

PATIENTS - A total of 104 women with a uterine weight > 500g who underwent laparoscopic hysterectomy using a manual morcellation technique.

INTERVENTION - Manual morcellation was done extracorporeally, within a partially exteriorized specimen bag, using a scalpel under direct visualization by the operating surgeon.

MEASUREMENTS AND MAIN RESULTS - A total of 104 laparoscopic hysterectomies were performed in women with a uterus weighing > 500g using a manual morcellation technique for specimen extraction. The median patient age was 48.1 years (range, 34-69 years), and the median body mass index was 31.0 kg/m(2) (range, 19.1-56.7 kg/m(2)). The median blood loss and specimen weight were 200 mL (range, 20-1200 mL) and 741.5 g (range, 500-1930 g), respectively. Morcellation was performed through an abdominal approach in 58.7% of the patients and through a vaginal approach in 41.3%. The median duration of morcellation was 14.8 minutes (range, 4.5-21.6 minutes) for the abdominal route and 11.7 minutes (range, 5.2-16.8 minutes) for the vaginal route. Occult malignancy was identified in 2 patients. There were no complications related to the morcellation technique or gross bag rupture.

CONCLUSION

Manual morcellation within an endoscopic bag allows for the extraction of large uteri without the use of a power morcellator. In our 5 years of experience, we have not experienced any incidence of gross spillage, visually noted bag rupture, or complications associated with our morcellation technique.

Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.

KEYWORDS - Contained morcellation; Endoscopic specimen bag; Laparoscopy; Large uteri; Manual Morcellation

Website : https://www.ncbi.nlm.nih.gov/pubmed/27058770

Noel NL1, Isaacson KB2.

Abstract

Morcellation is the fragmentation of tissue to facilitate removal of the specimen through small incision in minimally invasive surgery. This technique is not unique to gynecology and is used in general surgery with the goal of improved surgical outcomes including decreased pain, cost, hospital length of stay, and rapid return to normal activities and work. Gynecologic laparoscopic power morcellation (LPM) has come under increased scrutiny over the last 2 years due to widespread attention to a known but rare complication, an unanticipated dissemination of malignancy, namely occult uterine leiomyosarcoma. This chapter focuses on complications associated with gynecologic tissue morcellation from inoculation of benign or malignant tissue fragments within the peritoneal cavity and direct trauma from morcellation techniques. We also include a review of the various morcellation techniques from knife to electrical and the use of intraperitoneal specimen containment systems.

Copyright © 2016. Published by Elsevier Ltd.

KEYWORDS - contained; dissemination; knife; morcellation; sarcoma; vaginal

Cohen SL1, Hariton E, Afshar Y, Siedhoff MT.

Abstract

PURPOSE OF REVIEW - Safety concerns regarding morcellation of presumed benign fibroid disease have led to an increase in recent research activity on this topic, as well as advances in surgical technique.

RECENT FINDINGS - The prevalence of occult leiomyosarcoma is debated; however, estimates from a robust meta-analysis suggest it may be in the range of 1 case per 1960-8300 fibroid surgeries. Advancing age is an important clinical risk factor for occult malignancy. The impact of tumor morcellation may vary by mode of tissue removal, though tissue fragmentation is consistently associated with poorer outcomes. Decision and cost analyses continue to support laparoscopic hysterectomy as a low-morbidity and cost-effective approach. The increased scrutiny on fibroid procedures in the past few years may lead to changes in surgical approach; however, alternative tissue extraction options are evolving, including incorporation of contained morcellation.

SUMMARY - Although the incidence of occult leiomyosarcoma is low, outcomes are poor and may be worsened by morcellation. By addressing risk factors for malignancy and incorporating evolving surgical techniques into practice, gynecologists can continue to offer patients a minimally invasive approach for fibroid management.

Istre O1.

Abstract

DESIGN - A 45-year-old woman with a symptomatic uterine myoma suffering from heavy menstrual bleeding, incontinence, and pain pressure received ulipristal acetate (UPA [Esmya; Gideon Richter, Budapest, Hungary]) for 6 months.

SETTING - A Minimal Invasive Gynecology surgery Unit in Chopenhagen Denmark.

INTERVENTION - Her symptoms were reduced; however, after 3 months on UPA, she was then admitted because of increased pain. A high level of C-reactive protein was found, and necrosis of the myoma was assumed to be the reason. In Dec 2015, she opted for a laparoscopic hysterectomy because of the increasing symptoms and lack of conviction that the medical therapy would be sufficient.

MEASUREMENTS AND MAIN RESULTS - Ultrasound showed a 106 × 73 mm myoma with no abnormal blood flow or lacuna of fluid inside the myoma; there was no suspicion of malignancies. The video and the report have been approved by the local institutional review board. The weight of the contained morcellated uterus was 575 g, and pathology showed a malignant leiomyoma sarcoma. A postoperative positron emission tomographic scan showed 4 metastatic processes in the lungs.

CONCLUSION

The Food and Drug Administration has approved the PneumoLiner (Advanced Surgical Concepts, Dublin, Ireland); however, they also stress the point that the device "has not been proven to reduce the risk of spreading cancer." In this case, the UPA treatment actually led to a delay in the diagnosis, potentially with a larger or even metastatic tumor as a consequence.

KEYWORDS - Contained morcellation; Leiomyoma sarcoma; Myoma; Ulipristal acetate

Anapolski M1, Panayotopoulos D1, Alkatout I2, Soltesz S3, Mettler L2, Schiermeier S4, Hatzmann W4, Noé G5.

Abstract

INTRODUCTION - Unprotected power morcellation can lead to a spread of previously undiagnosed malignancy. We present a new containment bag with two closable trocar insertion sites to reduce this risk. This pilot study was designed to assess the feasibility of this device under everyday conditions.

MATERIAL AND METHODS - The containment bag was used in ten laparoscopic supracervical hysterectomies. We evaluated time requirement for bag insertion into the abdominal cavity and in-bag morcellation. A 2000 ml polyurethane morcellation bag was used for all interventions. All surgeries were carried out in a three-trocar setting.

RESULTS - We carried out ten supracervical hysterectomies. No intraoperative complications and no bag ruptures occurred. The meantime requirement to insert the bag and prepare the specimen for morcellation was 10.5min (range, 7-19 min). The mean specimen weight was 191.9g (range, 32-710g). Mean morcellation time was 10.5min (range, 3-28min), mean weight of remaining tissue and fluid in the bag after morcellation was 12.1g (range, 7-19 g).

CONCLUSION

The presented data demonstrate that the endobag can be successfully applied in the clinical routine. Further studies are required to evaluate additional characteristics, such as individual learning curve and time requirements.

KEYWORDS - Morcellation; improving power-morcellation; in-bag morcellation; myoma; subtotal hysterectomy

Website : https://www.ncbi.nlm.nih.gov/pubmed/27192613

Ikhena DE1, Paintal A2, Milad MP3.

Abstract

STUDY OBJECTIVE - To determine the feasibility and role of abdominopelvic washings at the time of laparoscopic power morcellation and to determine if endometrial or myometrial tissue will be detected before and after laparoscopic power morcellation.

DESIGN - A prospective pilot study (Canadian Task Force classification II-3).

SETTING - An academic medical center.

PATIENTS - All women who underwent laparoscopic myomectomy by a single provider at Northwestern Prentice Women's Hospital between Aug 2014 and Oct 2015.

INTERVENTIONS - Abdominopelvic washings were performed before and after laparoscopic power morcellation in a specimen bag. Washings were evaluated for the presence of intra-abdominal endometrial or myometrial tissue using cell block and cytospin techniques.

MEASUREMENTS AND MAIN RESULTS - A total of 13 cases were performed. Eleven subjects underwent multiport laparoscopy, and 2 underwent laparoendoscopic single-site surgery. Morcellation was performed within a 15 mm Tissue Retrieval System 100SB2 (Anchor Products, Addison, IL). Two sets of abdominopelvic washings were performed after completion of myomectomy: one before morcellation and the second after morcellation. As a control, washings of the inside of the empty specimen bag were performed after completion of morcellation in 1 patient. The operative outcomes analyzed included a median specimen weight of 313 g (range, 43-940 g), a median operative time in minutes of 161 minutes (range, 94-243 minutes), and a median estimated blood loss of 200 mL (range, 100-700 mL). There was no visual or cytologic evidence of intra-abdominal dissemination of uterine tissue before or after enclosed morcellation on evaluation by cytospin or cell block techniques. Only the washings from the inside of the specimen bag were found to have myometrial tissue on evaluation using the cell block technique.

CONCLUSION

Performing abdominopelvic washings at the time of laparoscopic power morcellation is a feasible method by which to evaluate and document the presence or absence of microscopic dissemination, with comparable operative parameters to what is already reported in the literature. When abdominopelvic washings are used as an intermediate outcome measure, enclosed bag morcellation appears to minimize tissue dissemination during laparoscopic power morcellation; however, additional and larger studies are needed.

Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.

KEYWORDS - Enclosed morcellation; Laparoscopic morcellation; Myomas

Website : https://www.ncbi.nlm.nih.gov/pubmed/27068277

Rimbach S1, Holzknecht A2, Schmedler C2, Nemes C3, Offner F3.

Abstract

INTRODUCTION - Endoscopic techniques have successfully reduced the invasiveness of hysterectomy, when compared to open procedures. Power morcellation, as a part of the minimal invasive concept, carries the risk of disseminating cells from the tissue specimen. The present observational study reports on first experiences using a new system (More-Cell-Safe, A.M.I., Austria) for contained in-bag morcellation during laparoscopic hysterectomy.

MATERIALS AND METHODS - The dual opening system allows two-port access without bag puncture. The optic is protected against spread cell contamination with a disposable sleeve. Application data were prospectively recorded on the first n = 7 consecutive patients and compared to n = 7 preceding patients undergoing uncontained morcellation.

RESULTS - Bag system use was surgically successful in 6 of 7 cases (85.7 %). Morcellated specimen weight ranged from 205 to 638 g (mean 413.33 ± 176.85; median 413). In one patient, the uterine specimen (1050 g) proved too large to be placed into the bag. Average time associated to the bag use was 16.2 ± 7.65 min, ranging from 8.5 to 26.5 min (median 14 min). Removed bags contained bloody fluid with residual tissue fragments weighing overall between 21 and 85 g. Spread spindle cells were detected in two cases after uncontained morcellation, but not after in-bag morcellation.

CONCLUSION

The experiences from our small pilot series prove technical feasibility in the clinical setting.

KEYWORDS - Hysterectomy; In-bag morcellation; Laparoscopy; Myomectomy; Power morcellation; Retrieval bag

Naval S1, Naval R2, Naval S2, Rane J2.

Abstract

STUDY OBJECTIVE - To demonstrate key steps in performing safe laparoscopic multiple myomectomy.

DESIGN - Video focuses on stepwise description of all major steps of the surgical technique.

PATIENT - Twenty-seven-year-old woman. Informed consent was taken from the subject, and the institutional review board approved this research.

INTERVENTION - Laparoscopic multiple myomectomy with morcellation in bag.

MEASUREMENTS AND MAIN RESULTS - About one-third of women with fibroids present with symptoms severe enough to warrant treatment. We demonstrate a case of a 27-year-old woman with complaints of secondary infertility and menorrhagia. On examination the uterus was enlarged up to 24 weeks size. Ultrasonography mapping located 7 myomas ranging in size from of 3 to 10 cm and classified as International Federation of Gynecology and Obstetrics classes 2, 3, 4, 5, 6, and 7. Generally, laparotomy or laparoscopy and mini-laparotomy is performed for such cases of multiple myomas. However, the total laparoscopic approach can confer benefits if performed following safe steps and within good time. The following were the key steps of surgery: (1) Higher port position using Lee Huang point for primary port, (2) intermittent vasopressin use for each myomectomy, (3) cold technique of myomectomy, (4) myoma lace creation, (5) multiple layer suturing using double-ended barbed sutures, (6) myoma garland creation, and (7) morcellation in a stomach-shaped bag.

CONCLUSION

The intermittent use of vasopressin is effective in reducing blood loss. Suturing using barbed sutures is less time consuming. Creating lace of myomas by passing a thread through each myoma, prevents losing them in the abdominal cavity and creating garland of myomas by tying two free ends of the lace helps in easier bagging. Morcellation in bag prevents dissemination of bits of myoma and visceral injury. These steps help in performing laparoscopic multiple myomectomy safely. However, this technique should be reserved for selected cases and should be performed by surgical teams with the required expertise and experience.

Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.

KEYWORDS - laparoscopy; morcellation in bag; multiple myomectomy

Website : https://www.ncbi.nlm.nih.gov/pubmed/27449692

Aoki Y1, Matsuura M2, Matsuno T2, Yamamoto T2.

Abstract

OBJECTIVE - To evaluate a modified single-access method of contained power morcellation performed with a single-access laparoscopic device and a new cordless electric morcellator. The study was a preliminary assessment of the feasibility and safety of the new technique.

STUDY DESIGN - A single university hospital observational study involving patients who underwent either laparoscopic myomectomy or laparoscopic hysterectomy. We evaluated the operative results, time required for the contained morcellation, any occurrence of bag leakage, and any complications.

RESULTS - The new contained power morcellation technique was applied in 12 patients (9 undergoing laparoscopic myomectomy and 3 undergoing laparoscopic hysterectomy). The mean bag introduction time was 21.8min (range, 14-37min); mean in-bag morcellation time was 11.5min (range, 1-26min); and mean total morcellation time was 36.8min (range, 19-66min). Visual inspection revealed no bag damage. There were no postoperative complications.

CONCLUSION

Single-site in-bag morcellation performed with our new technique requires neither bag penetration nor piercing with a trocar and thus may prove beneficial for preventing spillage and dissemination of unwanted cells and tissue.

Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

KEYWORDS - Laparoscopic myomectomy; Port-site metastasis; Power Morcellation

Website : https://www.ncbi.nlm.nih.gov/pubmed/27107329

Brolmann HA1, Sizzi O, Hehenkamp WJ, Rossetti A.

Abstract

Uterine leiomyoma is a highly prevalent benign gynecologic neoplasm that affects women of reproductive age. Surgical procedures commonly employed to treat symptomatic uterine fibroids include myomectomy or total or sub-total hysterectomy. These procedures, when performed using minimally invasive techniques, reduce the risks of intraoperative and postoperative morbidity and mortality; however, in order to remove bulky lesions from the abdominal cavity through laparoscopic ports, a laparoscopic power morcellator must be used, a device with rapidly spinning blades to cut the uterine tissue into fragments so that it can be removed through a small incision. Although the minimal invasive approach in gynecological surgery has been firmly established now in terms of recovery and quality of life, morcellation is associated with rare but sometimes serious adverse events. Parts of the morcellated specimen may be spread into the abdominal cavity and enable implantation of cells on the peritoneum. In case of unexpected sarcoma the dissemination may upstage disease and affect survival. Myoma cells may give rise to 'parasitic' fibroids, but also implantation of adenomyotic cells and endometriosis has been reported. Finally the morcellation device may cause inadvertent injury to internal structures, such as bowel and vessels, with its rotating circular knife. In this article it is described how to estimate the risk of sarcoma in a presumed fibroid based on epidemiologic, imaging and laboratory data. Furthermore the first literature results of the in-bagmorcellation are reviewed. With this procedure the specimen is contained in an insufflated sterile bag while being morcellated, potentially preventing spillage of tissue but also making direct morcellation injuries unlikely to happen.

Website : https://www.ncbi.nlm.nih.gov/pubmed/26799759

Venturella R1, Rocca ML2, Lico D1, La Ferrera N1, Cirillo R1, Gizzo S3, Morelli M1, Zupi E4, Zullo F1.

Abstract

OBJECTIVE - To evaluate whether manual in-bag morcellation could be efficiently proposed as alternative to the uncontained power technique.

DESIGN - Randomized controlled trial.

SETTING - Academic hospital.

PATIENT(S) - One hundred fifty-two premenopausal women eligible for myomectomy were screened, and 104 were randomized.

INTERVENTION(S) - Patients were randomized into two groups. In the experimental group, "in-bag" protected morcellation was performed. In the control group, patients were treated by uncontained power myoma removal.

MAIN OUTCOME MEASURE(S) - The primary endpoint was the comparison of morcellation operative time (MOT). The secondary endpoints were the comparisons of total operative time (TOT), simplicity of morcellation (as defined by the surgeon using a visual analogue scale), intraoperative blood loss, rate of complications, and postoperative outcomes.

RESULT(S) - A sample size of 51 per group (n = 102) was planned. Between Mar 2014 and Jan 2015, patients were randomized as follows: 53 to the experimental group and 51 to the control group. Most demographic characteristics were similar across groups. MOT was observed to be similar in both study groups (16.18 ± 8.1 vs. 14.35 ± 7.8 minutes, in the experimental and control groups, respectively). Fibroid size was identified as the principal factor influencing morcellation time (Pearson coefficient 0.484 vs. 0.581, in the experimental and control groups, respectively). No significant difference in TOT, simplicity of morcellation, delta Hb, postoperative pain, and postoperative outcomes were observed between groups.

CONCLUSION

The protected manual in-bag morcellation technique represents a time-efficient and feasible alternative, which does not interfere with surgical outcomes in women undergoing laparoscopic myomectomy.

Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

KEYWORDS - Fibroid; in-bag morcellation; myomectomy; power morcellation; sarcoma

Website : https://www.ncbi.nlm.nih.gov/pubmed/26801067

Cohen SL1, Morris SN2, Brown DN3, Greenberg JA4, Walsh BW5, Gargiulo AR5, Isaacson KB2, Wright KN6, Srouji SS5, Anchan RM5, Vogell AB6, Einarsson JI7.

Abstract

BACKGROUND - Safe tissue removal is a challenge for minimally invasive procedures such as myomectomy, supracervical hysterectomy, or total hysterectomy of a large uterine specimen. There is concern regarding disruption or dissemination of tissue during this process, which may be of particular significance in cases of undetected malignancy. Contained tissue extraction techniques have been developed in an effort to mitigate morcellation-related risks.

OBJECTIVE - The objective of the study was to quantify perioperative outcomes of contained tissue extraction using power morcellation, specifically evaluating parameters of tissue or fluid leakage from within the containment system.

STUDY DESIGN - This was a study including a multicenter prospective cohort of adult women who underwent minimally invasive hysterectomy or myomectomy using a contained power morcellation technique. Blue dye was applied to the tissue specimen prior to removal to help identify cases of fluid or tissue leakage from within the containment system.

RESULTS - A total of 76 patients successfully underwent the contained power morcellation protocol. Mean time for the containedmorcellation procedure was 30.2 minutes (±22.4). The mean hysterectomy specimen weight was 480.1 g (±359.1), and mean myomectomy specimen weight was 239.1 g (±229.7). The vast majority of patients (73.7%) were discharged home the same day of surgery. Final pathological diagnosis was benign in all cases. Spillage of dye or tissue was noted in 7 cases (9.2%), although containment bags were intact in each of these instances.

CONCLUSION

Findings are consistent with prior work demonstrating the feasibility of contained tissue extraction; however, further refinement of this technique is warranted.

Copyright © 2016 Elsevier Inc. All rights reserved.

KEYWORDS - Fibroid; in-bag morcellation; myomectomy; power morcellation; sarcoma

Website : https://www.ncbi.nlm.nih.gov/pubmed/26801067

van den Haak L1, Arkenbout EA2, Sandberg EM1, Jansen FW3.

Abstract

STUDY OBJECTIVE - To assess features of power morcellators (blade diameter, circular vs oscillating cutting, blade rotation speed, experience level) regarding their effect on the amount of tissue spill. In addition, the amount of tissue spill after the initial two-thirds and final one-third of the morcellated specimen was evaluated.

DESIGN - In vitro study (Canadian Task Force classification II-2).

SETTING - Laparoscopic skills lab of an academic hospital.

PATIENTS - Not applicable.

INTERVENTION - Power morcellation of beef tongue specimens.

MEASUREMENTS AND MAIN RESULTS - Twenty-four trials were performed. Morcellation was performed in 2 phases (phase 1: initial two-thirds of the total tissue; phase 2: last one-third of the tissue). With larger blade diameter a decline was observed in both the weight of the spilled particles (phase 1) and the number of spilled particles (phases 1 and 2 and both combined) (weight phase 1: 6.5 g vs 6.3 g vs 2.2 g for 12.5 mm vs 15 mm vs 20 mm, respectively, p = .04; number particles: phase 1, 10.2 vs 7.2 vs 2.7, p = .01; phase 2, 22.9 vs 19.0 vs 8.9, p = .02; total, 34.7 vs 26.2 vs 11.6, p = .01). Also, spinning of the tissue mass due to torque applied by the rotating blade occurred later when blade size increased, and the size of the spilled particles was larger (weight of morcellated tissue at onset of torque: 136 g vs 198 g vs 222 g, p = .07; size: .6 g vs .9 g vs .8 g, p = .1). In the oscillation mode there was less total spill (6.8 g/100 g vs 21.3 g/100 g, p = .01, for oscillation and circular cutting, respectively).

CONCLUSION

The present study demonstrates that less spill is created by power morcellators with an oscillating blade and/or a large diameter (≥20 mm). Furthermore, when using a large-diameter blade the spilled particles are larger, and less morcellation repetitions are needed. By combining these features with currently introduced contained morcellation, the safety of the morcellation process with respect to tissue spill can be further improved.

Anapolski M1, Panayotopoulos D2, Alkatout I3, Soltesz S4, Schiermeier S5, Noé G6.

Abstract

BACKGROUND - Electromechanical power morcellation is an important tool of modern laparoscopy. Recent reports on the spread of previously undetected malignancy by power morcellation indicate the need for additional protective devices to reduce this risk. We conducted a study to obtain the first data concerning the safety of an endobag with three closable ports during morcellation and subsequent bag extraction under in vitro conditions, mimicking the settings in our operating theater. The second purpose of the study was to establish a minimal width of the skin incision necessary to safely extract the sealed bag after morcellation.

METHODS - The morcellation test was carried out on 11 stained porcine muscle tissue samples with one additional sample as a control. The insufflation pressure was set at 12 mmHg. After filling the endobag with blue dye solution, an additional extraction test was conducted by pulling the closed bag through a template with apertures of various diameters. For each opening, a series of ten bag extractions was carried out.

RESULTS - No loss of solid material or fluid was recorded during the morcellation test. The extraction test showed a loss of fluid for template openings smaller than 18 mm. The force necessary to extract the bag was inversely related to the width of the aperture.

CONCLUSION

The data suggest that under the evaluated conditions, the use of a closable morcellation bag can considerably improve the patient's safety during morcellation. Further studies are necessary to evaluate the influence of the bag on operating time, intervention costs and complications.

KEYWORDS - In-bag morcellation; Intracorporeal morcellation; Myoma; Power morcellation; Sarcoma

Website : https://www.ncbi.nlm.nih.gov/pubmed/27194256

Rimbach S1, Holzknecht A2, Nemes C3, Offner F3, Craina M4.

Abstract

INTRODUCTION - Minimal invasive approaches have proven beneficial for patients undergoing myomectomy and hysterectomy, but necessary tissue morcellation carries the risk of cell dissemination in rare cases of inadvertent malignancy. Performing the morcellation process within a contained bag system may prevent spilling and therefore enhance safety of the laparoscopic procedures.

MATERIAL AND METHODS - The present study describes the development and experimental evaluation of a new bag system in vitro and in vivo in a pig model of laparoscopic supracervical hysterectomies.

RESULTS - The main results on n = 8 procedures with in-bag morcellation compared to n = 8 controls without bag indicate reproducible feasibility and protective effect of the new bag, which is the first published to our knowledge that does not require puncturing in a standard multiport laparoscopy setting. Overall surgery time was significantly prolonged in the bag group by 12.86 min (P = 0.0052; 95 % confidence interval 4.64-21.07), but peritoneal washings were negative for muscle cells in all cases with bag use, compared to positive cytology in 5/8 cases without bag (P = 0.0256).

CONCLUSION

Clinical trials will now be necessary to investigate the reproducibility of these encouraging data in human application.

KEYWORDS - Hysterectomy; In-bag morcellation; Laparoscopy; Myomectomy; Power morcellation; Retrieval bag

Website : https://www.ncbi.nlm.nih.gov/pubmed/26093523

Lynam S1, Young L1, Morozov V1,2, Rao G1,3, Roque DM1,3.

Abstract

Minimally invasive surgical techniques compared with laparotomy offer the advantages of less intraoperative blood loss, shorter hospitalization, fewer wound complications and faster return to baseline activity for both hysterectomy and myomectomy. While morcellation allows for the laparoscopic removal of large specimens, it may result in intraperitoneal dissemination of benign disease or upstaging of occult malignancy leading to compromised survival. There has been heightened scrutiny over appropriate patient selection and preoperative assessment in light of recent warnings against power morcellation issued by the US FDA. This commentary therefore summarizes the magnitude of such risks associated with uterine morcellation, current national regulatory statements and potential merits of risk-reducing approaches such as contained morcellation. The importance of patient counseling is underscored.

Solima E1, Scagnelli G2, Austoni V1, Natale A1, Bertulessi C1, Busacca M1, Vignali M1.

Abstract

OBJECTIVE - To evaluate the integrity of the endoscopic bag after transvaginal in-bag morcellation of uteri that need to be removed by vaginal morcellation during total laparoscopic hysterectomy (TLH).

DESIGN - Prospective pilot study (Canadian Task Force classification II-2).

SETTING - University hospital.

PATIENTS - Twelve patients with uteri that needed to be removed and who required vaginal morcellation underwent TLH from Sep 2014 to Feb 2015, without suspected or confirmed malignancy.

INTERVENTIONS - After transvaginal in-bag morcellation of uteri at the end of TLH, careful visual inspection of the endoscopic pouch, using diluted methylene blue, was carried out, highlighting any minimal bag damage.

MEASUREMENTS AND MAIN RESULTS - No gross rupture was encountered after morcellation; however, 4 minimal ruptures were recognized (33%) after filling up the bag with diluted methylene blue.

CONCLUSION

Minimal lesions of the bag may occur after transvaginal morcellation of uteri that need to be removed by vaginal morcellation; this may potentially affect the spread of cancer cells into the abdominal cavity.

Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.

KEYWORDS - Endobag; Total laparoscopic hysterectomy; Vaginal morcellation

Website : https://www.ncbi.nlm.nih.gov/pubmed/26205578

Winner B1, Porter A, Velloze S, Biest S.

Abstract

OBJECTIVE - To compare perioperative outcomes of uncontained and contained power morcellation in total laparoscopic hysterectomy.

METHODS - Women who underwent total laparoscopic hysterectomy that required utilization of power morcellation between July 2012 and Jan 2015 in the Division of Minimally Invasive Gynecology at an academic tertiary care center were included. In Feb 2014, the division began performing all power morcellation contained within a large insufflated bag in an attempt to reduce dissemination of benign and malignant uterine tissue. Data were collected from a prospective database and analyzed as a retrospective cohort. The primary outcome was operative time. Secondary outcomes included estimated blood loss, length of stay, pathology, uterine weight, and complications, including blood transfusion, conversion to open, intraoperative organ injury, pelvic infection, readmission, or reoperation.

RESULTS - A total of 152 patients were identified: 101 uncontained morcellations and 51 contained morcellations. The baseline demographic characteristics between the two groups were similar. Operative time was longer in the contained morcellation group (184 compared with 164 minutes, P=.01). There were no cases of visible bag disruption or dissemination of uterine tissue in the containedmorcellation group.

CONCLUSION

Contained power morcellation at the time of total laparoscopic hysterectomy is associated with a 20-minute increase in operative time when compared with uncontained morcellation.

Cohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, Fader AN, Shibley T.

Abstract

OBJECTIVE - To describe a technique for contained power morcellation within an insufflated isolation bag at the time of uterine specimen removal during minimally invasive gynecologic procedures.

METHODS - Over the study period of Jan 2013 to Apr 2014, 73 patients underwent morcellation of the uterus or myomas within an insufflated isolation bag at the time of minimally invasive hysterectomy or myomectomy. This technique involves placing the specimen into a large plastic bag within the abdomen, exteriorizing the opening of the bag, insufflating the bag within the peritoneal cavity, and then using a power morcellator within the bag to remove the specimen in a contained fashion. Procedures were performed at four institutions and included multiport laparoscopy, single-site laparoscopy, multiport robot-assisted laparoscopy, or single-site robot-assisted laparoscopy. Demographic and perioperative characteristics were collected for the cases.

RESULTS - Surgical specimen morcellation within an insufflated isolation bag was successfully used in all cases. The median operative time was 114 minutes (range 32-380 minutes), median estimated blood loss was 50 mL (range 10-500 mL), and the median specimen weight was 257 g (range 53-1,481 g). There were no complications related to the contained morcellation technique nor was there visual evidence of tissue dissemination outside of the isolation bag.

CONCLUSION

Morcellation within an insufflated isolation bag is a feasible technique. Methods for morcellating uterine tissue in a contained manner may provide an option to minimize the risks of open power morcellation while preserving the benefits of minimally invasive surgery.

Website : http://www.ncbi.nlm.nih.gov/pubmed/25162248

Trupti Tanaji Kanade, MD, Joanne B. McKenna, MB, BCh, Sarah Choi, MB, ChB, Brian P. Tsai, MD, David M. Rosen, MBBS, Gregory M. Cario, MBBS, Danny Chou, MBBS

Abstract

STUDY OBJECTIVE - To demonstrate a new technique of contained in bag morcellation of a myoma after laparoscopic myomectomy.

DESIGN - Step-by-step explanation of the technique in a narrated video.

INTERVENTION - Contained In Bag Morcellation of myoma after laparoscopic myomectomy.

MEASUREMENTS AND MAIN RESULTS - Recent controversy regarding the risk of disseminating occult leiomyosarcomatous tissue during morcellation means we need to revise our current approach to tissue extraction at laparoscopic myomectomy and morcellation in general. Herein we present a novel technique, conceived by Dr. Danny Chou, called the Sydney Contained In Bag Morcellation technique for laparoscopic myomectomy. In this technique an EndoCatch bag (EndoCatch II Auto Suture Specimen Retrieval Pouch; Covidien, Mansfield, MA) is introduced in the typical fashion, the myoma is retrieved, and the mouth of the bag is exteriorized onto the abdominal wall. A 12-mm trocar is then introduced within the bag, and pneumoperitoneum is created before introducing an optical balloon tip port (KII Balloon Blunt Tip System; Applied Medical, Rancho Santa Margarita, CA) and the power morcellator device. Morcellation is then performed within the bag, under direct vision. This technique may offer a safer approach to morcellation because the bowel is not within the morcellation field and there is lower risk of disseminating occult leiomyosarcomatous tissue during morcellation. Subsequent to the morcellation process, suctioning of the bag removes any aerosolized particles of myoma, further minimizing the risk of possible dissemination.

CONCLUSION

This technique may enable a minimally invasive approach to myomectomy to continue as a viable option in the era since the warning by the US Food and Drug Administration.

Website : http://www.jmig.org/article/S1553-4650%2814%2900349-5/abstract

McKenna JB, Kanade T, Choi S, Tsai BP, Rosen DM, Cario GM, Chou D

Abstract

STUDY OBJECTIVE - To demonstrate a modification of the Shibley single-port technique suitable for morcellation of large myomatous uteri after total laparoscopic hysterectomy in a contained environment within the abdominal cavity [1].

DESIGN - Step-by-step explanation of the technique using descriptive text and an educational video.

SETTING - In light of recent concern about the use of power morcellators and increasing the risk of disseminating occult leiomyosarcomatous myoma fragments throughout the abdominal cavity, we propose this new technique for management of morcellation of large myomatous uteri after total laparoscopic hysterectomy, to contain the morcellation process and minimize the risk. This technique, which we have coined "Sydney Contained in Bag Morcellation" involves introduction of a sterile plastic bag (Dual Drawstring Bag, 460 × 460 mm; Southern Cross Hospital Supplies, Northmead, NSW, Australia) before introducing an optical port and the power morcellator. Before insertion this bag is modified in several ways to facilitate bag opening and specimen retrieval. The dual drawstring is removed and replaced with a 150-cm length of PDS I (polydioxanone) suture material as the new drawstring, with its exit at the mouth of the bag in the 6 o'clock position. Five stay sutures are placed around the bag mouth, corresponding to the 12, 1, 5, 7, and 11 o'clock positions. This assists with opening the mouth of the bag intraabdominally and enables orientation to be maintained. The bag is then inserted in a McCartney tube (Gates Healthcare, Cheshire, UK). Corresponding slits are made in the tip of the tube to enable the end of the stay sutures to be securely held in place during tube insertion. These ends are then retrieved using atraumatic graspers and exteriorized and clipped alongside their corresponding port sites. After hysterectomy the uterus is placed in the bag, and the stay sutures maintain the mouth opening. The bag is closed and its mouth exteriorized onto the abdominal wall at the site of the umbilical trocar. The 12-mm umbilical trocar is then replaced within the bag, and pseudopneumoperitoneum is created. Once established, an optical trocar is introduced via one of the lower quadrant port sites using a balloon tip trocar (Kii; Applied Medical, Rancho Santa Margarita, CA). The insufflation tubing is attached to this trocar, and the umbilical trocar is replaced with the morcellator device. Morcellation is performed under direct vision in a contained environment. Once complete, all fragments are removed, and the bag is washed out. The original pneumoperitoneum is re-established. The bag is then removed during aspiration to encourage negative pressure relative to the re-established pneumoperitoneum, minimizing aerosolized fragment leakage.

INTERVENTION - Contained in bag morcellation of a large myomatous uterus during total laparoscopic hysterectomy. This technique has been specifically developed to address the concerns of morcellating large myomatous uteri after hysterectomy. In the case of supracervical hysterectomy or myomectomy, in which there would be no vaginal conduit to exploit, we use an endocatch bag, inserted in the usual manner, with reintroduction of the umbilical trocar within the mouth of the bag to enable creation of pseudopneumoperitoneum. Again, an optical trocar would be introduced in a lower lateral port, and morcellation would be performed under direct vision. An article describing this technique has recently been published [2].

CONCLUSION

The Sydney Contained in bag Morcellation technique offers a possible solution to the risk of dissemination of benign morcellated and potentially leiomyosarcomatous myoma fragments. Certain aspects of the procedure are key to its success. The stay sutures are essential to facilitate orientation and opening of the bag mouth. The McCartney tube enables easier insertion of the flaccid bag into the vagina, and the suture-retaining slits enable the mouth of the bag to be opened quickly and easily. We have used this technique in 5 cases with uteri ranging in weight from 350 to 978 g. Recently, similar techniques have been described for use in single-port surgery and conventional laparoscopy [1,2]. Our technique is suitable for use with large uteri after total laparoscopic hysterectomy because the large capacity of the bag enables containment of uteri that would exceed the capacity of manually deployed specimen retrieval bags. This technique offers an alternative to vaginal morcellation, with the advantage of improved vision during morcellation and the ability to morcellate large uteri using a familiar instrument and view.

Website : http://www.ncbi.nlm.nih.gov/pubmed/25048565

Cohen SL, Greenberg JA, Wang KC, Srouji SS, Gargiulo AR, Pozner CN, Hoover N, Einarsson JI.

Abstract

STUDY OBJECTIVE - To evaluate risk of leakage and tissue dissemination associated with various contained tissue extraction (CTE) techniques.

DESIGN - In vitro study (Canadian Task Force classification: II-1).

SETTING - Academic hospital simulation laboratory.

INTERVENTION - Beef tongue specimens weighing 400 to 500g were stained using 5 mL indigo carmine dye and morcellated under laparoscopic guidance within a plastic box trainer. CTE was performed via 3 different techniques: a stitch-sealed rip-stop nylon bag and multi-port approach; a one-piece clear plastic 50 × 50-cm isolation bag and multi-port approach; or a 1-piece clear plastic 50 × 50-cm isolation bag and single-site approach. Four trials of each CTE method were performed and compared with an open morcellation control. All bags were insufflated to within 10 to 25 mmHg pressure with a standard CO2 insufflator. Visual evidence of spilled tissue or dye was recorded, and fluid washings of the box trainer were sent for cytologic analysis.

MEASUREMENTS AND MAIN RESULTS - Blue dye spill was noted in only 1 of 12 CTE trials. Spillage was visualized from a seam in 1 of the 4 stitch-sealed rip-stop nylon bags before morcellation of the specimen. The only trial in which gross tissue chips were visualized in the box trainer after morcellation was the open morcellation control. However, cytologic examination revealed muscle cells in the open morcellation washings and in the washings from the trial with dye spill. Muscle cells were not observed at cytologly in any of the other samples.

CONCLUSION

CTE did not result in any leakage or tissue dissemination with use of the single-site or multi-port approach when using a 1-piece clear plastic 50 × 50-cm isolation bag. Further studies are needed to corroborate these findings in an in vivo context and to evaluate use of alternate bag options for specimen containment.

Website : http://www.ncbi.nlm.nih.gov/pubmed/24928740

Singhvi SK, Allan W, Williams ED, Small PK.

Abstract

BACKGROUND - A reliable method of retrieval of laparoscopically resected organs is required. The physical properties of three commercial systems available for clinical use (two plastic, one woven fabric) were examined.

METHODS - Pig abdominal walls and gallbladders containing steel balls to represent gallstones were used to simulate organ retrieval on 60 occasions. The performance of retrieval bags was measured in terms of the temporal profile of pressure developed inside the bag, the force on the bag during withdrawal, and whether or not the bag could be retrieved intact. The force versus elongation relationship was also determined for each bag.

RESULTS - Although there was a wide range of maximum pressures recorded (14-320 mmHg) with each retrieval system, the mean pressures in the plastic systems were significantly higher. The forces recorded during attempted withdrawal of both plastic bags were significantly lower than those with the fabric system (BERT bag: mean (range) 87 (25-165) N; Endocatch: 40 (7-123) N; Endopouch: 40 (14-68) N; P = 0.005 Endocatch versus BERT, P = 0.004 Endopouch versus BERT). The BERT bags tore more easily at the site of the grasper.

CONCLUSION

Plastic retrieval systems were less likely to burst than fabric systems when subjected to simulated retrieval, and required less force for withdrawal. Plastic systems may therefore be associated with less tumour seeding or gallstone spillage as a consequence of bag disruption.

Website : http://www.ncbi.nlm.nih.gov/pubmed/12190686

Jon I. Einarsson, MD, PhD, MPH, Sarah L. Cohen, MD, MPH, Noga Fuchs, MD, Karen C. Wang, MD

Abstract

CONCLUSION

In-bag morcellation seems to be a viable alternative to open power morcellation and offers the advantage of minimal to no spillage of tissue or fluids during morcellation. We report our initial experience and technique using this approach.

Website : http://www.jmig.org/article/S1553-4650%2814%2900256-8/abstract

Xiaoyue M. Guo, BA, Xiao Xu, PhD, Vrunda B. Desai, MD

Abstract

OBJECTIVE - Electromechanical morcellation (EMM), commonly known as "power morcellation", often allows patients the benefits of minimally invasive surgical (MIS) approaches including decreased morbidity and mortality. 1 However, the role of EMM in myomectomy and hysterectomy has recently come under scrutiny due to concerns of heightened risks of intraperitonieal cancer dissemination in women with occult malignancies. In Nov 2014, the U.S. Food and Drug Administration (FDA) issued a safety warning for using EMM to remove uterine fibroids2. Despite prevalent public debate, it is unclear whether and how gynecologic surgeons have changed their practice. The current study seeks to assess influence of the FDA warning regarding EMM on management strategies in hysterectomies / myomectomies.

DESIGN - We conducted an online survey of American Association of Gynecologic Laparoscopists Minimally Invasive Gynecology Surgery Fellowship program faculty during Dec 2014-Feb 2015 using the Qualtrics Survey Tool (Qualtrics, Provo, UT). Email addresses were obtained from fellowship program's websites. Of the 189 faculty, 40 were undeliverable, resulting in an effective target population of 161 faculty members. Survey questions were developed based on literature review and expert opinion, and pilot-tested on a convenience sample of gynecologic surgeons before final implementation.

RESULTS - Forty-six faculty completed the survey (response rate=29%). Of these respondents, 62% were male, 60% had over 10 years of experience, 60% were in gynecology-only practices, and 67% performed more than 50 hysterectomies / myomectomies annually. Although 28 respondents (61%) said they have never diagnosed leiomyosarcoma, 12 (26%) encountered at least one patient in 2013 with occult malignancy during a benign procedure. Forty-three surgeons (93%) reported using morcellation during hysterectomies / myomectomies in 2013, with uncontained EMM being the most commonly used form (81%). Table 1 summarizes practice changes in these 43 surgeons. Thirty-six (78%) noted that they changed their surgical approach for hysterectomies / myomectomies after the FDA warning. Of them, 21 (58%) used minilaporotomy, 18 (50%) used specimen retrieval pouches, and 15 (42%) used vaginal extraction in a bag, while 14 (39%) reduced the use of laparoscopic supracervical hysterectomy and 9 (25%) changed the route of hysterectomy to total laparoscopic or total abdominal hysterectomy.

CONCLUSION

Prior to the FDA warning, EMM was commonly used in hysterectomies / myomectomies. However, gynecologic surgeons have since adopted a variety of changes to their management strategies. Variations in preoperative evaluation demonstrates an inability to definitely diagnose malignancy preoperatively. 5 The large proportion of respondents who now use larger incisions or open procedures raises concern about potentially higher patient morbidity. Safety, efficiency, and long-term outcome data for the innovative surgical techniques that have been adopted (e.g., various containment bags, vaginal incisions, and intraoperative biopsies) are urgently needed. Further research on the prevalence of occult uterine cancer in women undergoing hysterectomies / myomectomies for presumed benign indications and their prognosis after EMM will also facilitate discussion on optimal management approaches, as our current knowledge is largely based on studies with small sample sizes and non-representative samples.3,4 Efforts to prevent cancer dissemination must be balanced with the lost benefits of MIS and potential risk of newly adopted yet understudied surgical techniques.

Website : http://www.freepapers.ir/PDF/10.1016-j.ajog.2015.02.027.pdf?hash=x6IYKek3eERkYtu5GVIGGQ

Henrik Halvor Springborg, Olav Istre

Abstract

The risk of intraperitoneal fragment dissemination of uterine tissue, especially the dissemination of unexpected leiomyosarcoma during electromechanical morcellation, has been increasingly debated during the last year. An improved technique for contained morcellation of uterine tissue inside an insufflated plastic bag during laparoscopy is presented. Twenty-one consecutive contained morcellations were carried out during the summer of 2014, at one institution. Five laparoscopic myomectomies and 16 hysterectomies were performed. Standard laparoscopic equipment was used and a transparent plastic bag was introduced into the abdominal cavity through the umbilical incision mounted on two curved blunt metal probes, which facilitated the placement of the uterine tissue into the bag. Morcellation was carried out inside the plastic bag through the opening in the umbilicus. All 21 morcellations during the study period were successfully performed. The median operative time was 105 min (range 45-180 min) and applying plastic bag and trocar median 10 min (range 4-30 min). Median specimen weight was 560 g (range 80-1265 g). No complications occurred, and no unintended bag perforation was identified. The presented improved contained morcellation technique is feasible in laparoscopic hysterectomy and myomectomy. Larger studies will however be required before the general introduction of the method.

Website : http://link.springer.com/article/10.1007%2Fs10397-015-0879-3

Parekh AR1, Moran ME, Newkirk RE, Desai PJ,

Abstract

BACKGROUND AND PURPOSE - Tissue removal can be a simple process of withdrawal of the entire organ, piecemeal removal with surgical clamps, or mechanical morcellation. Different mechanical morcellators exist that each have advantages and disadvantages. We have investigated a particular morcellator having an internal mechanized blade system that increases the chances of damage to tissue isolation sacks but removes large volumes of intact organ that can more readily be evaluated histologically. The primary premise of this investigation is that a fluid-filled sack would be less likely to be damaged by the activated blades of the morcellator.

MATERIALS AND METHODS - Utilizing a Steiner Morcellator (Karl Storz, Culver City, CA), two porcine kidneys were morcellated within the large LapSac (Cook Urological, Spencer, IN). Two environmental variables were evaluated: dry sac morcellation and fluid-filled sac morcellation. Each session was timed, fluid leakage identified, grasping of the sacks quantified, and gross spillage noted. The tissues were submitted for pathologic evaluation to quantify any differences grossly or histologically. All LapSacs were inspected for gross violation and inflated to distention with fluid to check for tiny leaks.

RESULTS - The Steiner Morcellator worked much better within the confines of the LapSac filled with fluid. There were no perforations in our experimental setting. It was not possible discern use of fluid-filled sacks histologically.

CONCLUSION

The Steiner Morcellator can be utilized safely in the LapSac if cautious observation and fluid-filled sack conditions are maintained. The extracted tissue is easily evaluated histologically.

Website : http://www.ncbi.nlm.nih.gov/pubmed/10772513

Hans Brolmann & Vasilios Tanos & Grigoris Grimbizis & Thomas Ind & Kevin Philips & Thierry van den Bosch & Samir Sawalhe & Lukas van den Haak & Frank-Willem Jansen & Johanna Pijnenborg & Florin-Andrei Taran & Sara Brucker & Arnaud Wattiez & Rudi Campo & Peter O’Donovan & Rudy Leon de Wilde & On behalf of the European Society of Gynaecological Endoscopy (ESGE) steering committee on fibroid Morcellation

Abstract

BACKGROUND AND PURPOSE - In laparoscopy, specimens have to be removed from the abdominal cavity. If the trocar opening or the vaginal outlet is insufficient to pass the specimen, the specimen needs to be reduced. The power morcellator is an instrument with a fast rotating cylindrical knife which aims to divide the tissue into smaller pieces or fragments. The Food and Drug Administration (FDA) issued a press release in Apr 2014 that discouraged the use of these power morcellators. This article has the objective to review the literature related to complications by power morcellation of uterine fibroids in laparoscopy and offer recommendations to laparoscopic surgeons in gynaecology. This project was initiated by the executive board of the European Society of Gynaecological Endoscopy. A steering committee on fibroid morcellation was installed and experienced ESGE members requested to chair an action group to address distinct clinical questions. Clinical questions were formulated with regards to the sarcoma risk in presumed uterine fibroids, diagnosis of sarcoma, complications of morcellation and future research. A literature review on the different subjects was conducted, systematic if appropriate and feasible. It was concluded that the true prevalence of uterine sarcoma in presumed fibroids is not known given the wide range of prevalences (0.45–0.014 %) from meta-analyses mainly based on retrospective trials. Age and certain imaging characteristics such as ‘lacunes’ suggesting necrosis and increased central vascularisation of the tumour are associated with a higher risk of uterine sarcoma, although the risks remain low. There is not enough evidence to estimate this risk in individual patients. Complications of morcellation are rare. Reported are direct morcellation injuries to vessels and bowel, the development of so-called parasitic fibroids requiring reintervention and the spread of sarcoma cells in the abdominal cavity, which may possibly or even likely upstaging the disease. Momentarily in-bag morcellation is investigated as it may possibly prevent morcellation complications. Because of lack of evidence, this literature review cannot give strong recommendations but offers only options which are condensed in a flow chart. Prospective data collection may clarify the issue on sarcoma risk in presumed fibroids and technology to extract tissue laparoscopically from the abdominal cavity should be perfected.

Website : http://link.springer.com/article/10.1007%2Fs10397-015-0878-4

Jason D. Wright, MD; Ana I. Tergas, MD; Rosa Cui, BS1; William M. Burke, MD; June Y. Hou, MD; Cande V. Ananth, PhD, MPH; Ling Chen, MD, MPH; Catherine Richards, PhD; Alfred I. Neugut, MD, PhD; Dawn L. Hershman, MD

Abstract

IMPORTANCE - Myomectomy, the excision of uterine leiomyoma, is now commonly performed via invasive surgery. Electric power morcellation, or fragmentation of the leiomyoma with a mechanical device, may be used to facilitate extraction of the leiomyoma.

OBJECTIVE - To analyze the prevalence of underlying cancer and precancerous changes in women underwent myomectomy with and without electric power uterine morcellation.

DESIGN, SETTING AND PARTICIPANTS - We used a US nationwide database to retrospectively women who underwent myomectomy at 496 hospitals from Jan 2006 to Dec 2012. Use of electric power morcellation at the time of myomectomy was investigated. The prevalence of uterine cancer, uterine neoplasms of uncertain malignant potential, and endometrial hyperplasia were estimated. Multivariable mixed-effects regression models were developed to examine predictors of use of electric power morcellation and factors associated with adverse pathologic outcomes.

MAIN OUTCOMES AND MEASURES - Use of electric power morcellation at the time of myomectomy examined. The occurrence of uterine cancer and precancerous uterine lesions was determined.

RESULTS - The cohort consisted of 41 777 women who underwent myomectomy at 496 included 3220 (7.7%) who had electric power morcellation. Uterine cancer was identified in 73 (1 in 528) women who underwent myomectomy without electric power morcellation (0.19%; 95% CI, 0.15%-0.23%) and in 3 (1 in 1073) women who underwent electric power morcellation (0.09%; 95% CI, 0.02%-0.27%). The corresponding rates of any pathologic finding (cancer, tumors of uncertain malignant potential, or endometrial hyperplasia) were 0.67% (n = 257) (95% CI, 0.59%-0.75%) (1 in 150) and 0.43% (n = 14) (95% CI, 0.21%-0.66%) (1 in 230), respectively. Advanced age was the strongest risk factor for uterine cancer.

CONCLUSIONS AND RELEVANCE - The prevalence of cancers and precancerous abnormalities of the uterus in women who undergo myomectomy with or without electric power morcellation is low overall, but risk increases with age. Electric power morcellation should be used with caution in older women undergoing myomectomy.

Website : http://oncology.jamanetwork.com/article.aspx?articleid=2118570#Methods

Matthew T. Siedhoff, MD, MSCR, Stephanie B. Wheeler, PhD, MPH, Sarah E. Rutstein, BA, Elizabeth J. Geller, MD, Kemi M. Doll, MD, Jennifer M. Wu, MD, MPH, Daniel L. Clarke-Pearson, MD

OBJECTIVE - The purpose of this study was to model outcomes in laparoscopic hysterectomy with morcellation compared with abdominal hysterectomy for the presumed fibroid uterus and to examine short- and long-term complications and death.

STUDY DESIGN - A decision tree was constructed to compare outcomes for a hypothetical cohort of 100,000 premenopausal women who underwent hysterectomy for presumed fibroid tumors over a 5-year time horizon. Parameter and quality-of-life utility estimates were determined from published literature for postoperative complications, leiomyosarcoma incidence, death related to leiomyosarcoma, and procedure-related death.

RESULTS - The decision-tree analysis predicted fewer overall deaths with laparoscopic hysterectomy compared with abdominal hysterectomy (98 vs 103 per 100,000). Although there were more deaths from leiomyosarcoma after laparoscopic hysterectomy (86 vs 71 per 100,000), there were more hysterectomy-related deaths with abdominal hysterectomy (32 vs 12 per 100,000). The laparoscopic group had lower rates of transfusion (2400 vs 4700 per 100,000), wound infection (1500 vs 6300 per 100,000), venous thromboembolism (690 vs 840 per 100,000) and incisional hernia (710 vs 8800 per 100,000), but a higher rate of vaginal cuff dehiscence (640 vs 290 per 100,000). Laparoscopic hysterectomy resulted in more quality-adjusted life years (499,171 vs 490,711 over 5 years).

CONCLUSION

The risk of leiomyosarcoma morcellation is balanced by procedure-related complications that are associated with laparotomy, including death. This analysis provides patients and surgeons with estimates of risk and benefit on which patient-centered decisions can be made

Website : http://www.ajog.org/article/S0002-9378(15)00200-8/abstract?cc=y

Goggins, Emily R. BA; Greenberg, James A. MD; Cohen, Sarah L. MD, MPH; Morris, Stephanie Newman MD; Brown, Douglas N. MD; Einarsson, Jon Ivar MD, MPH

Abstract

INTRODUCTION - Tissue dissemination during uncontained laparoscopic electromechanical morcellation has raised safety concerns. This study sought to assess whether contained tissue extraction using electromechanical morcellators entirely within a bag is a safe, practical technique for preventing tissue spillage.

METHODS - Patients undergoing laparoscopic or robotic hysterectomy or myomectomy at four hospitals were included. After surgical dissection, specimens to be extracted were placed into a containment bag with blue dye. The bag was insufflated intracorporeally, and electromechanical morcellation and extraction of tissue was performed. The containment system's integrity was evaluated visually for leakage of dye or tears in the bag.

RESULTS - A total of 76 participants were included in the analysis (42 hysterectomy, 34 myomectomy). The average age was 43.16 years (+/-8.53), with an average body mass index (calculated as weight (kg)/[height (m)]2) of 26.47 (+/-5.93). Thirty-three patients had a history of abdominal surgery. All cases employed a laparoscopic or robotic multiport technique. Morcellation took an average time of 30.2 minutes (+/-22.4). In one case, there was a tear before morcellation but no bag tears occurred during morcellation process. Spillage of dye or tissue was noted in seven cases, although containment bags were intact in each of these instances. There was one intraoperative complication with an estimated blood loss of 3600 mL and conversion to open radical hysterectomy. The median estimated blood loss was 50 mL (range 0-3600). The most common pathology finding was benign leiomyomas.

CONCLUSION

Contained tissue extraction using electromechanical morcellation and intracorporeally insufflated bags may provide a safe alternative to uncontained morcellation by decreasing the spread of tissue in the peritoneal cavity while allowing for the traditional benefits of laparoscopy.

Website : http://journals.lww.com/greenjournal/Abstract/2015/05001/Efficacy_of_Contained_Tissue_Extraction_for.92.aspx

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