Search

Purpose: This systematic review aims to comprehensively assess the safety and efficacy of transvaginal morcellation within an enclosed bag in gynecological surgeries, with a focus on its benefits, potential risks, and recommendations for its use., Methods: We conducted a comprehensive search of Epistemonikos, Web of Science, Medline (PubMed), Scopus, and Cochrane databases for studies on transvaginal contained morcellation in adult patients undergoing gynecological surgeries. The review included 22 studies that met the inclusion criteria, encompassing diverse surgical procedures, patient profiles, and outcomes. These studies were thoroughly reviewed and analyzed to assess the safety and efficacy of the morcellation technique., Results: Key findings from the selected studies indicate that transvaginal morcellation within an enclosed bag offers several advantages in gynecological surgeries, including reduced invasiveness, shorter operative times, and minimal blood loss when compared to conventional methods. The risk of tumor recurrence or dissemination appears to be low when appropriate precautions are taken, emphasizing the technique's safety, especially when performed by experienced surgical teams. While some studies reported complications, these were generally not directly associated with the morcellation technique., Conclusion: Transvaginal morcellation within an enclosed bag demonstrates potential as a safe and effective option for gynecological surgeries. The technique offers the benefits of minimally invasive procedures, including reduced bleeding, shorter recovery times, and improved cosmetic outcomes. This review also highlights the need for standardization in study methodologies and reporting, as the heterogeneity in outcomes across the selected studies poses challenges in drawing definitive conclusions., (© 2024. The Author(s).)

Objective: To evaluate the efficacy and safety of an endoscopic bag during laparoscopic morcellation of leiomyoma or myomatous uterus., Materials and Methods: A total of 48 patients with symptomatic leiomyoma were randomized for laparoscopic morcellation in two groups: group A with a specific endoscopic bag or group B without any bag. The primary outcome measure was the detection of smooth muscle cells from washing after power morcellation determined by peritoneal cytology and immunohistochemistry (IHC)., Results: Cytology and IHC from group A did not revealed any smooth muscle cells, while 29% of cases (7/24) from group B were positive ( p = .009). The duration of the surgical procedure was the same in both groups. The duration of positioning the bag did not change significantly during the study. Only in one case the use of the bag was difficult due to a low pneumoperitoneum., Conclusions: The use of a morcellation bag is efficient to prevent the spread of smooth muscle cells during the morcellation of leiomyoma or myomatous uterus. This study confirms the feasibility and the safety of the laparoscopic inbag morcellation versus open morcellation., Competing Interests: The authors declare that they have no competing interest., (Copyright © 2021 Chloe Bensouda-Miguet et al.)

Background: Uterine leiomyomas, also referred to as myomas or fibroids, are benign tumours arising from the smooth muscle cells of the myometrium. They are the most common pelvic tumour in women. The estimated rate of leiomyosarcoma, found during surgery for presumed benign leiomyomas, is about 0.51 per 1000 procedures, or approximately 1 in 2000. Treatment options for symptomatic uterine leiomyomas include medical, surgical, and radiologically-guided interventions. Laparoscopic myomectomy is the gold standard surgical approach for women who want offspring, or otherwise wish to retain their uterus. A limitation of laparoscopy is the inability to remove large specimens from the abdominal cavity through the laparoscope. To overcome this challenge, the morcellation approach was developed, during which larger specimens are broken into smaller pieces in order to remove them from the abdominal cavity via the port site. However, intracorporeal power morcellation may lead to scattering of benign tissues, with the risk of spreading leiomyoma or endometriosis. In cases of unsuspected malignancy, power morcellation can cause unintentional dissemination of malignant cells, and lead to a poorer prognosis by upstaging the occult cancer. A strategy to optimise women's safety is to morcellate the specimens inside a bag. In-bag morcellation may avoid the dissemination of tissue fragments., Objectives: To evaluate the effectiveness and safety of protected in-bag extracorporeal manual morcellation during laparoscopic myomectomy compared to intra-abdominal uncontained power morcellation., Search Methods: On 1 July 2019, we searched; the Cochrane Gynaecology and Fertility Group Specialized Register of Controlled Trials, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, PubMed, Google Scholar, and two trials registers. We reviewed the reference lists of all retrieved full-text articles, and contacted experts in the field for additional and ongoing trials., Selection Criteria: We included all randomised controlled trials comparing in-bag extracorporeal manual morcellation versus intracorporeal uncontained power morcellation during laparoscopic myomectomy in premenopausal women., Data Collection and Analysis: We followed standard Cochrane methods. Two review authors independently reviewed the eligibility of trials, extracted data, and evaluated the risk of bias. Data were checked for accuracy. The summary measures were reported as risk ratios (RR) or mean differences (MD) with 95% confidence interval (CI). The outcomes of interest were a composite of intraoperative and postoperative complications, operative times, ease of morcellation, length of hospital stay, postoperative pain, conversion to laparotomy, and postoperative diagnosis of leiomyosarcoma. Results for the five main outcomes follow., Main Results: We included two trials, enrolling 176 premenopausal women with fibroids, who underwent laparoscopic myomectomy. The experimental group received in-bag manual morcellation, during which each enucleated myoma was placed into a specimen retrieval bag, and manually morcellated with scalpel or scissors. In the control group, intracorporeal uncontained power morcellation was used to reduce the size of the myomas. No intraoperative complications, including accidental morcellation of the liver, conversion to laparotomy, endoscopic bag disruption, bowel injury, bleeding, accidental injury to any viscus or vessel, were reported in either group in either trial. We found very low-quality evidence of inconclusive results for total operative time (MD 9.93 minutes, 95% CI -1.35 to 21.20; 2 studies, 176 participants; I² = 35%), and ease of morcellation (MD -0.73 points, 95% CI -1.64 to 0.18; 1 study, 104 participants). The morcellation operative time was a little longer for the in-bag manual morcellation group, however the quality of the evidence was very low (MD 2.59 minutes, 95% CI 0.45 to 4.72; 2 studies, 176 participants; I² = 0%). There were no postoperative diagnoses of leiomyosarcoma made in either group in either trial. We are very uncertain of any of these results. We downgraded the quality of the evidence due to indirectness and imprecision, because of limited sites in high-income settings and countries, small sample sizes, wide confidence intervals, and few events., Authors' Conclusions: There are limited data on the effectiveness and safety of in-bag morcellation at the time of laparoscopic myomectomy compared to uncontained power morcellation. We were unable to determine the effects of in-bag morcellation on intraoperative complications as no events were reported in either group. We are uncertain if in-bag morcellation improves total operative time or ease of morcellation compared to control. Regarding morcellation operative time, the quality of the evidence was also very low and we cannot be certain of the effect of in-bag morcellation compared to uncontained morcellation. No cases of postoperative diagnosis of leiomyosarcoma occurred in either group. We found only two trials comparing in-bag extracorporeal manual morcellation to intracorporeal uncontained power morcellation at the time of laparoscopic myomectomy. Both trials had morcellation operative time as primary outcome and were not powered for uncommon outcomes such as intraoperative complications, and postoperative diagnosis of leiomyosarcoma. Large, well-planned and executed trials are needed., (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Objective: To introduce an effective approach using a self-made retrieval bag during laparoscopic myomectomy to contain tissue extraction., Design: Step-by-step video explanation of the surgical procedure with still pictures and surgical video clips to demonstrate the detailed technique, approved by the Shengjing Hospital of China Medical University., Setting: University hospital., Patient(s): A 32-year-old woman diagnosed with a uterine myoma (diameter, 6 cm). She had endured 5 years of intermittent lower abdominal pain and 2 years of infertility., Intervention(s): A self-made retrieval bag during laparoscopic myomectomy was used (consists of four steps) to contain tissue extraction. 1. Self-made retrieval bag using a sterile medical bag. 2. Inspect the pelvic cavity, evaluate and determine the location and number of myomas. 3. Resect the myoma. 4. Morcellate the myoma into pieces inside the retrieval bag using laparoscopic power morcellation., Main Outcome Measure(s): Value and feasibility of using a self-made retrieval bag in laparoscopic myomectomy., Result(s): The myoma was successfully and completely resected by laparoscopy using a self-made retrieval bag to contain tissue extraction. Operative time was 93 minutes. In the follow-up period, the patient did not report any symptom of iatrogenic parasitic myoma. The woman had a pregnancy at month 26 after operation and underwent a cesarean section. This resulted in a full-term baby., Conclusion(s): Our surgical approach demonstrated a number of noteworthy advantages. The use of retrieval bag to contain tissue extraction during laparoscopic morcellation can avoid the risk of iatrogenic parasitic myoma. The retrieval bag is self-made using a sterile packing bag, which is cost free and also reduces operative expenses., (Copyright © 2019 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Study Objective: To determine the ability of tissue containment systems to prevent leakage of cancer cell surrogates when subjected to forces encountered during power morcellation procedures., Design: In vitro study., Setting: Medical device research laboratory., Interventions: Samples from 7 different legally marketed tissue containment bags (1 of which is indicated for power morcellation) were subjected to dye and bacteriophage penetration tests at pressures ranging from 0.5 to 50 times the insufflation pressure. The minimum pressure required to cause bag leakage was measured. Subsequently, the morcellation leakage safety factor for each bag was determined as the ratio of the minimum leakage pressure of the bag to the total pressure contributed from insufflation pressure and mechanical forces acting during the power morcellation procedure., Measurement and Main Results: The leakage performance of the bags varied markedly from brand to brand. No correlation was found between leakage pressure and the bag material or the total bag thickness. The leakage pressures ranged from 26 mmHg to >1293 mmHg for the 7 bags, and safety factors ranged from 1 to 50 when only the insufflation pressure was considered. However, if the morcellation forces were included in the calculation, the safety factor dropped by 6-fold for all brands and dropped below 1, indicating likelihood of leakage, for 2 of the 7 brands., Conclusion: This study provides a mechanism for more realistically simulating the conditions experienced by containment bags during morcellation and quantifying the level of safety provided by the bags., (Published by Elsevier Inc.)

Power morcellation in laparoscopic surgery enables specialists to carry out minimally invasive procedures such as hysterectomies and myomectomies by cutting specimens into smaller pieces using a rotating blade and removing pieces through a laparoscope. Unexpected uterine sarcoma treated by surgery involving tumor disruption could be associated with poor prognosis. The current study aims to shed light on power morcellation from a medicolegal perspective: the procedure has resulted in adverse outcomes and litigation, and compensation for plaintiffs, as published in various journals cited in PubMed and MEDLINE, Cochrane Library, EMBASE, and GyneWeb. Considering the claims after the US Food and Drug Administration warnings on morcellation, the current study broadens the scope of research by including search engines, legal databases, and court filings (DeJure, Lexis Nexis, Justia, superior court of New Jersey, and US district court of Minnesota) between 1995 and 2019. Legal records show that courts determine professional responsibility regarding complications, making it essential to document adherence to safety protocols and specific guidelines, when available. Sound medical practices and clearly stated institute best practices result in better patient outcomes and are important when unfavorable clinical outcomes occur; adverse legal decisions can be avoided if there are grounds to prove professional conformity with specific guidelines and the unpredictability of an event., (Copyright © 2020 AAGL. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate current practice and adherence to AAGL and BSGE power morcellation guidelines., Study Design: Cross-sectional survey., Setting: United Kingdom., Patients/population: 157 National Health Service (NHS) hospital trusts (organisation comprising of one or more hospitals) offering gynaecological services., Intervention: A questionnaire was emailed between March-July 2018 and completed by Lead/ Directors of Gynaecology within each organisation. Descriptive statistics were used to present results from this study., Measurements/results: We assessed power morcellation practice patterns, informed consent processes and outcomes over the last 12 months. We received 136 responses (87 % response rate). Power morcellation was performed by a third (59, 37.6 %) of all UK hospitals. The median number of gynecologists performing morcellation per organisation was 2 (Q1-Q3: 2-4). A median of 7 morcellators (Q1-Q3: 0-17) were purchased and 7 morcellators (Q1-Q3: 1.25-15.75) used per annum. A median of 10 (Q1-Q3: 2.0-15.0) laparoscopic hysterectomies and 5 (Q1-Q3: 0.5-9.0) myomectomies requiring morcellation were performed per annum. Almost, a third of hospitals did not perform an endometrial biopsy or MRI. 79.7 % (47) of trusts consented for power morcellation and 76 %, (46) explained risk of inadvertent leiomyosarcoma. 83.3 %, (50) had no patient literature and almost half had no audit process 45 %, (27)., Conclusion: Current UK practice does not reflect recommendations from the AAGL or BSGE. Deficiencies were identified in pre-operative evaluation, local governance procedures, and consenting practices regarding use of a power morcellator and risk of occult leiomyosarcoma., (Copyright © 2019. Published by Elsevier B.V.)

Aim: We examine the impact of the new risk information about a surgical device on surgery and patient outcomes for hysterectomy in the inpatient setting. Methods: We utilize a difference-in-differences approach to assess the impact of new risk information on patient outcomes in the inpatient setting between 2009 and 2014. The inpatient data come from a nationally representative sample of hospitalizations in the USA. We use the likelihood of laparoscopic surgery, measures of resource use and surgical complications as outcome variables. Results: We estimate a three-percentage point decrease in the likelihood of receiving laparoscopic hysterectomy, a one-percentage point increase in the likelihood of experiencing a surgical complication and no impact on resource use, relative to pre-existing means. Conclusion: Our findings show that there was movement away from laparoscopic surgery in the months following the dissemination of new risk information. These changes had limited effect on patient outcomes.

Objective: To demonstrate how bladder ultrasound can be useful in completing morcellation during difficult Holmium Laser Enucleation of the Prostate (HoLEP). As HoLEP has emerged as a standard of care for the treatment of benign prostatic hyperplasia, multiple studies have reported the potentially catastrophic complication of bladder injury during morcellation. This video aims to assist any urologist performing HoLEP by providing step-by-step instruction for using ultrasound to complete morcellation safely., Methods: Enucleation is performed using a 26-French continuous flow scope, off-set laser bridge with a laser stabilization catheter, and a 550 µm holmium laser fiber. Once the median and lateral lobes have been enucleated, the outer sheath is removed and the nephroscope is inserted to facilitate morcellation. Under dual inflow irrigation, the Piranha morcellator (Richard Wolf, Knittlingen, Germany) is introduced and set to the manufacturer's recommended settings of 1500 rpm. A 3.5-MHz convex abdominal ultrasound transducer (Hitachi Prosound Alpha 7; Hitachi Aloka Medical America, Wallingford, CT) under B-mode is used to visualize the bladder, predominantly in the sagittal orientation. Morcellation proceeds under simultaneous ultrasound and direct cystoscopic guidance., Results: The distended bladder is visualized concurrently with the ultrasound and via the nephroscope as the Piranha engages the adenoma and begins morcellation. Once the adenoma is engaged, the operator then drops their hands to place the morcellator in the center of the bladder. Ultrasound provides real-time feedback as to the location of the morcellator in relation to the adenoma and bladder., Conclusion: This video highlights the use of intraoperative bladder ultrasound as a visual aid to assist during the morcellation portion of HoLEP. This proof of concept demonstrates that ultrasound can be an additional tool to utilize during difficult cases when cystoscopic visualization during morcellation is limited., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Importance: Few gynecologic surgeons understand the mechanism by which surgical instruments are approved for human use and marketing or do they appreciate the central role they play in postmarket surveillance and reporting after instruments have come to market., Objective: Using the experience with the uterine morcellator, this review will detail the Food and Drug Administration (FDA) system for approving surgical instruments and the potential pitfalls of this process., Evidence Acquisition: Literature review and public documents from the FDA., Results: The FDA 510(k) approval process for surgical instruments relies largely on postmarket surveillance as exemplified by the uterine power morcellator, which was approved before sufficient evidence was available regarding its potential harms., Conclusions: The current system currently transfers the responsibility of ensuring safety and efficacy to the public, patients, and providers. To minimize potential harm, the FDA needs to incorporate a greater standard of evidence into its framework for the approval and regulation of medical devices. The burden of these requirements should be borne at least in part by the companies bringing equipment to market., Relevance: It is incumbent on all surgeons to be vigilant in their objective critical assessment of new instrumentation and report their outcomes after they come to market.

Competing Interests: Dr. Thompson is a consultant for Boston Scientific, Olympus, Medtronic, Apollo Endosurgery, and USGI Medical.All other authors have no conflict of interest.

Study Objective: Few reports have investigated the use of endoscopic retrieval bags in the context of laparoscopic myomectomy with electromechanical morcellation. We performed a leak test of a specially designed endoscopic bag system in women undergoing laparoscopic myomectomy with contained electromechanical morcellation., Design Classification: Prospective study., Setting: University hospital., Patients: Thirty-one women undergoing laparoscopic myomectomy with contained electromechanical morcellation., Interventions: Electromechanical morcellation was introduced for large specimen extraction during laparoscopic procedures. Complications such as retained/disseminated parasitic tissue were documented., Measurements and Main Results: Systematic peritoneal washings were performed at 3 specific times: at baseline, T1, once the peritoneal cavity was accessed laparoscopically; T2, when the myometrial incision was closed after myomectomy; and T3, after contained electromechanical morcellation. After retrieval of the endoscopic bag from the abdominal cavity, visual inspection and water test on the bag with NaCl infiltration were performed to detect leaks attributed to intraoperative perforations. A pathologist performed cytologic analyses on the 3 washings. The mean endoscopic bag procedure duration was 9 minutes. The use of a specially designed endoscopic bag system was found to be easy in 45% of cases, and no complications were reported. Cytologic washings were positive for smooth muscle cell detection in 8 cases (25.8%) at T2 and 3 cases (9.7%) at T3. All positive cases at T3 already had detectable smooth muscle cells at T2. After retrieval from the abdominal cavity, perforations on the optic access of the endoscopic bag were observed in 3 cases., Conclusion: The results from this pilot study are encouraging. The use of a specially designed endoscopic bag system could be an adjuvant to reduce the risk of disseminating cells during myomectomy., (Copyright © 2019 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: To compare 3 laparoscopic contained morcellation techniques in terms of feasibility and safety., Design: Pilot study in an animal model (Canadian Task Force classification II-1)., Setting: Gynecologic oncology department at a cancer institute in Japan., Patients: Porcine model., Interventions: Three contained morcellation techniques were tested, each multiple times in 1 of 3 anesthetized female pigs: manual morcellation (8 times), dual-site power morcellation (8 times), and single-site power morcellation (6 times). All were tested on beef tongue introduced abdominally., Measurements and Main Results: The following variables were compared: bag insertion time, morcellation time, bag removal time, total in-bag morcellation time, and the volume of pneumoperitoneum CO 2 consumed. Bag rupture was evaluated ex vivo on completion of the procedure. Bag insertion time (in minutes) was significantly greater for dual-site morcellation (10.91 ± 3.38) than for manual (4.58 ± 2.47, p = .003) or single-site power (7.25 ± .77, p = .014) morcellation. Bag removal time (in minutes) was also significantly greater for dual-site morcellation (.85 ± .11 vs .27 ± .14, p<.001, vs .33 ± .59, p = .001). Total in-bag morcellation time, although greatest for manual morcellation at 21.4 ± 10.2 minutes, did not differ significantly between techniques. CO 2 consumption was significantly low for manual morcellation. Visual inspection revealed no bag damage when manual morcellation was performed, but bag damage occurred in 3 dual-site cases and in 1 single-site case., Conclusion: Considering preventing specimen leakage as the main aim of contained morcellation, the bag used for power morcellation needs improvement. Although manual morcellation requires an umbilical wound of about 25 mm, the absence of bag damage, acceptable total morcellation time, relatively low CO 2 consumption, and nonuse of a power device, which translate to an economic benefit, lead us to conclude that manual morcellation will remain advantageous into the future., (Copyright © 2019. Published by Elsevier Inc.)

Objectives: To evaluate the feasibility and safety of two-port myomectomy using bag-contained manual morcellation compared to three-port myomectomy using power morcellation., Material and Methods: A retrospective chart review was conducted for 428 cases of either two-port or three-port laparoscopic myomectomy performed by single operator in the university hospital between January 2011 and December 2016., Results: The cohorts of three-port myomectomy with power morcellation was consisted of two hundred and forty-eight patients. One hundred and eighty patients underwent two-port myomectomy with manual morcellation in contained bag. Two-port group showed shorter hospital stay (5.16 ± 1.39 d vs. 4.83 ± 1.19 d, p = 0.001), less estimated blood loss (61.8 ± 58.2 mL vs. 50.2 ± 52.4 mL, p = 0.001), and higher hemoglobin level at postoperative day 1 (10.7 ± 1.17 g/dL vs. 11.0 ± 1.14 g/dL, p = 0.028) with statistical significance. Morcellation time (25.8 ± 9.30 min vs. 18.9 ± 10.11 min, p = 0.001) and total operative time (82.4 ± 30.19 min vs. 76.4 ± 25.47 min, p = 0.047) were also significantly shorter in two-port group. There were no identified spillages of fibroids, ruptures of specimen bag during manual morcellation in two-port myomectomy. In both groups, there were no cases of leiomyosarcoma diagnosed postoperatively., Conclusion: Two-port laparoscopic myomectomy with bag-contained manual morcellation is a feasible and safe alternative for three-port with power morcellation. Its surgical outcomes were shown to be superior to conventional laparoscopic myomectomy according to our study but further evaluation in near future is needed., (Copyright © 2019. Published by Elsevier B.V.)

Purpose: To evaluate the feasibility of using contained endobags (Morsafe ® ) in the retrieval of the specimen during laparoscopic surgeries in presumably benign myomatous pathology., Material and Methods: We conducted a retrospective single center case - control study on 239 patients, between 01.05.2014 and 31.12.2017 for uterine myomata, presumed to be benign. The analyzed parameters were the method for contained specimen retrieval, the time of bag manipulation, practicability of action and the perioperative complications rate. The present work has been reported in accordance with the STROCSS criteria and guidelines [1]., Results: the main laparoscopic interventions were myomectomy (n = 148 cases) and LASH (laparoscopic supracervical hysterectomy) (n = 68 cases), LASH with bilateral salpingectomy (n = 7), LASH and bilateral adnexectomy (n = 3), LTH (laparoscopic total hysterectomy) (n = 3), LTH and bilateral adnexectomy (n = 1), radical LTH with lymphonodectomy (n = 2), LTH with bilateral salpingectomy (n = 1) and adenomyomectomy (n = 6). In 3 cases using contained closed bags, there was an evidence of malignancy in the pathological sections: leiomyosarcoma (n = 1) and endometrial carcinoma (n = 2). There were no adverse events and no intra - or postoperative bag - induced complications. Regarding the intraoperative duration, the time of bag introduction was about 7 min, and morcellation approximately 12 min., Conclusion: in - bag morcellation through endobag (Morsafe ® ) proved to be a safe laparoscopic method in retrieval of myomatous tissue, potentially reducing the risk of dissemination and thereby improving the patients' safety avoiding spreading of benign disease and malignancy, but preserving the benefits of minimally invasive surgery. The advantages concerned not only the operating time and costs, but also the safety aspects in case of malignancy. As the system can help to reduce risk of cell dissemination it could also reduce the risk in case of occult malignancy., (Copyright © 2019. Published by Elsevier Ltd.)

Introduction: The DrillCutTM morcellator is marketed for its fast and highly efficient removal of prostatic tissue and a higher level of patient safety. However, a paucity of publications has looked into its actual efficacy and safety. The aim of our study was to evaluate its ex vivo and in vivo efficiency and to compare its results with other devices presented in the literature., Patients and Methods: We conducted a prospective pilot study on patients who underwent holmium laser enucleation of the prostate (HoLEP) from 2017 to 2018 using the Top-Down technique. Enucleated adenomas were morcellated using the DrillCutTM morcellator. We collected both preoperative and operative data. Operative data included the enucleated adenoma weight and operative time. Various morcellator parameters were collected including morcellation time and efficiency. We recorded the encountered complications and device malfunction. Ex vivo characteristics were evaluated in terms of morcellation speed and aspiration power., Results: Sixty consecutive patients with a median age of 72.8 years were included. The enucleated adenoma was retrieved in 12.5 min (4-58). The median resected prostatic weight was 90 g (44-242). The DrillCutTM efficiency was calculated as 6.46 g/min (2.7-15). Only one patient had a simple bladder mucosal injury. Device malfunction was encountered in 4 patients (6.6%) due to blockage of the morcellator blades. The ex vivo aspiration speed was 52 s/L, while the morcellation power was 14 g/2 min., Conclusion: Our results showed that the DrillCut morcellator was effective and safe in managing our patients post-HoLEP. The DrillCutTM has better ex vivo morcellation power but modest aspiration speed in comparison to other morcellators., (© 2019 S. Karger AG, Basel.)

Introduction: Morcellation of the adenoma after laser enucleation of the prostate (LEP) is both time-consuming and prone to complications. We have designed a novel polyethylene sack (ProSac) to improve the morcellation process following LEP. Both silicone and cadaver models were utilized to evaluate the safety and efficacy of ProSac., Methods: The inanimate model used tissue-mimicking silicone to accurately approximate bladder volume and compliance. The second model was developed using a fresh cadaver. Heat-fixed chicken breast was used to mimic enucleated prostatic adenoma. Morcellation of the simulated adenoma tissue was tested in both models with and without the ProSac. Morcellated tissue was removed from the filter, desiccated, and weighed after each run to establish morcellation efficiency. Visual inspection was used to evaluate for mucosal injury or bladder perforation. A hydromanometer was placed in the cadaveric bladder to measure bladder pressure., Results: The device was able to capture up to 30 g of tissue with good closure while maintaining good distention and visualization during morcellation. In the silicone model, morcellation efficiency with the device was 4.6 g/minute, while efficiency without the device was 2.6 g/minute (p = 0.03). In the cadaveric model, mean entrapment time was 22 ± 11 seconds. Morcellation efficiency with the device was 2.1 g/minute when excluding entrapment time and 1.9 g/minute including entrapment time. Without the ProSac, morcellation efficiency was 1.2 g/minute (p = 0.05). In both models, multiple mucosal injuries occurred without the device, while none occurred with the device. Bladder pressure was similar between study arms., Conclusions: The ProSac is a novel device that can provide additional safety during adenoma morcellation. It may also achieve clinically and statistically significant improvement in morcellation efficiency without increasing bladder pressure.

Purpose of Review: Submucosal uterine leiomyomas are a common benign pelvic tumor that can cause abnormal uterine bleeding and may contribute to infertility and miscarriage. Hysteroscopic myomectomy is the treatment of choice to alleviate bleeding from these myomas and to normalize the uterine cavity. This review discusses the techniques and recent evidence for hysteroscopic myomectomy and examines the two primary surgical tools employed today: the bipolar resectoscope and hysteroscopic mechanical morcellator., Recent Findings: Hysteroscopic myomectomy has been a popular treatment for symptomatic submucosal fibroids for decades; it is a minimally invasive, low-cost, low-risk procedure, and is associated with high patient satisfaction. There have been rapid advances in the surgical technology available for this procedure. Both the bipolar resectoscope and the hysteroscopic mechanical morcellator are appropriate tools to remove submucosal myomas. Although the hysteroscopic morcellators have been associated with shortened operative time and a decreased learning curve, the data are limited for their use on type 2 fibroids. The strength of the bipolar resectoscope lies in its ability to resect deeper type 2 fibroids., Summary: The evidence suggests that no one technique should be used for all patients, but rather a choice of technique should be taken on a case-by-case basis, depending on the myoma number, size, type, and location. Gynecologists must become knowledgeable about each of these techniques and their associated risks to safely offer these surgeries to their patients.

Purpose of Review: As the Food and Drug Administration raised concern over the power morcellator in 2014, the field has seen significant change, with patients and physicians questioning which procedure is safest and most cost-effective. The economic impact of these decisions is poorly understood., Recent Findings: Multiple new technologies have been developed to allow surgeons to continue to afford patients the many benefits of minimally invasive surgery while minimizing the risks of power morcellation. At the same time, researchers have focused on the true benefits of the power morcellator from a safety and cost perspective, and consistently found that with careful patient selection, by preventing laparotomies, it can be a cost-effective tool., Summary: Changes since 2014 have resulted in new techniques and technologies to allow these minimally invasive procedures to continue to be offered in a safe manner. With this rapid change, physicians are altering their practice and patients are attempting to educate themselves to decide what is best for them. This evolution has allowed us to refocus on the cost implications of new developments, allowing stakeholders the opportunity to maximize patient safety and surgical outcomes while minimizing cost.

Purpose of Review: This review was written in an effort to describe the evolution of power morcellation equipment from their creation to their current state. In addition, this review addresses the continuously evolving equipment involved with power morcellation and looks to describe where the field is headed in the future. In addition, recent professional and federal recommendations have changed the way power morcellation is being approached and has led to the development of contained morcellation systems, which, although in their infancy, are also being proven to be well tolerated options., Recent Findings: This article will review the most current research on electronic power morcellation and the multiple attempts to prove superiority from the many different types of equipment, and also the many different approaches to morcellation. In addition, with the adaptation to contained morcellation, this review will cover research focused on optimizing a containment system and the techniques involved., Summary: In summary, this review is aimed at describing many of the currently available power morcellation products and contained morcellation systems in an effort to allow physicians to understand the different options available, and to discuss well tolerated, effective, and clinically proven techniques that can lead to improved surgical outcomes in the future.

Purpose of Review: To review the data-derived prevalence rates for occult leiomyosarcoma (LMS), and outcomes for women who have these tumors inadvertently morcellated., Recent Findings: In 2014, the Food and Drug Administration presented data showing the prevalence rates of occult LMS at 2.02/1000 surgeries for presumed benign fibroids. They also attributed poorer outcomes for women undergoing power morcellation of these tumors. Two more recent meta-analyses have shown much lower rates, as low as one in 8300 surgeries when including only prospective studies, and one in 1428 surgeries when including both prospective and retrospective studies. When looking at outcomes, both studies show no difference in outcomes when comparing power or any other type of morcellation. The most recent data suggest that even intact removal has no advantage when looking at mortality rates., Summary: Prevalence of occult LMS remains quite rare, but outcomes after intact removal or any type of morcellation appear to be no different.

Purpose of Review: Controversy exists surrounding extraction of tissue in gynecologic surgery using morcellators following cases of disseminated uterine cancers discovered after the use of electromechanical morcellators. This chapter traces the history of tissue extraction in gynecology and reviews the evolving scientific data and opinions regarding the future of morcellation., Recent Findings: Since the initial Food and Drug Administration warning about morcellation in 2014, subsequent studies do not support the Food and Drug Administration's high incidence of occult uterine cancer. Current research continues, focusing on methods of contained tissue morcellation, both laparoscopically and vaginally., Summary: Minimally invasive surgical techniques have revolutionized gynecology, drastically reducing the need for open procedures. To maximize patient safety while preserving the rapid recovery and low morbidity of laparoscopic and vaginal approaches, optimal methods of tissue extraction need to be developed and promulgated.

Objective: To evaluate operating room (OR) costs associated with the 2 available morcellators in the United States in a matched cohort and to determine benign prostatic hyperplasia surgeon's morcellator preference., Materials and Methods: Patients from 2013, the last year our institution exclusively used the VersaCut device, were matched 1:1 with the most recent patient cohort, utilizing the Wolf Piranha morcellator. Cost of morcellation including the expense of OR time and disposable instrument costs were calculated. A survey to the Endourological Society e-mail listserv was sent to determine morcellator preference., Results: We identified 142 patients who underwent holmium laser enucleation of the prostate in 2013. When compared with the VersaCut group, morcellation efficiency (4.4 vs 7.0 g/min, P <.01) and expense of OR time ($1420.80 vs $992.21, P <.005) both favored the Piranha morcellator system even when the costs of disposable instruments were factored into the analysis ($1338.81 vs $1637.50, P <.05). A total of 126 urologists responded to the survey. Of these, 56 (44.5%) perform transurethral prostate enucleations, which included 48 (86%) holmium. More endourologists use the VersaCut (n = 33, 59%) than the Piranha (n = 24, 43%) morcellator. Qualities that impacted the preference of morcellator included the preferred device is safer, faster, easier to use, reusable, and less expensive., Conclusion: We identified a significant improved efficiency and improved cost savings utilizing the Piranha morcellator even when controlling for disposable costs. Of the endourologists who responded to the survey, less than half perform transurethral enucleation. Morcellator preference is largely based on safety, efficiency, and ease of use, whereas cost and reusablility were of lesser importance., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: To evaluate the association between the U.S. Food and Drug Administration (FDA) communication discouraging use of power morcellators on changes in surgical practice for women with uterine leiomyomas., Methods: This is a cross-sectional study using data from 2013 to 2014 in the Healthcare Cost and Utilization Project State Inpatient and State Ambulatory Surgical Databases from Arizona, Florida, Kentucky, and New Jersey. Women with a diagnosis of leiomyomas who underwent hysterectomy or myomectomy were included in the analysis. Multivariable models were used to assess changes in the proportion of hysterectomies performed laparoscopically, vaginally, or by laparotomy in the 15 months before the FDA safety communication in April 2013 (January 2013 to March 2014) to the 9 months after the FDA communication (April to December 2014). Changes in the proportion of women who underwent myomectomy compared with hysterectomy were also evaluated during this time period., Results: There were 77,637 hysterectomy and myomectomy cases analyzed from states with both inpatient and ambulatory surgery data; 59% of patients were outpatients. Overall, there was a 4% (95% CI 3.2-4.8%) decrease in the use of laparoscopic hysterectomy for treatment of uterine leiomyomas from 62% of all hysterectomies before the FDA communication on morcellation to 58% afterward. Changes in surgical practice were more pronounced in the inpatient compared with outpatient setting; inpatient laparoscopic hysterectomy decreased by 7% (95% CI 6.1-7.9%) from 24% to 17% of all hysterectomies with an accompanying increase in abdominal hysterectomy of 8% (95% CI 6.7-8.6%) from 71% to 79%. There were no significant changes in the proportion of women with leiomyomas who underwent myomectomy compared with hysterectomy., Conclusion: The FDA communication discouraging the use of power morcellators was associated with a decline in laparoscopy to perform hysterectomy, particularly in the inpatient setting. There was no change in the selection of myomectomy compared with hysterectomy for leiomyoma treatment after the FDA communication.

Objective: This study was a quality improvement project investigating patterns of hysterectomy practice including changes in surgical techniques and patient outcomes after manufacturer withdrawal of a laparoscopic power morcellator from our hospitals in July 2014., Study Design: This time-series pre and post retrospective review examined data from electronic health records, comparing one year when a laparoscopic power morcellator was available (Year 1, mid-2013 to mid-2014) to one year after withdrawal (Year 2, mid-2014 to mid-2015). Data were from patients of 8 gynecologists in a multispecialty group associated with a large, integrated care and coverage delivery system in Washington State. Analyzed were 100 patients for Year 1 and 133 patients for Year 2. Analysis was by two-sided chi-square tests comparing practice patterns and outcomes in the two years., Results: For hysterectomy route, no significant difference was seen between Years 1 and 2 in percent surgeries that were abdominal or laparoscopic (including robotic). For minimally invasive hysterectomies, significantly more transvaginal hysterectomies were performed in Year 2 (22%) than Year 1 (14%) (p<0.05). In Year 2, no laparoscopic supracervical hysterectomies occurred, with total laparoscopic or vaginal hysterectomies performed instead. Transvaginal uterus morcellation increased from 13% in Year 1 to 24% in Year 2 (p<0.05). Bilateral salpingectomies increased in Year 2 as well (p<0.05). Among patient factors, estimated blood loss, surgical site infection, total operative time, and hospital length of stay were not significantly different between Years 1 and 2. Body mass index, race/ethnicity, and age did not differ between years. No patients had occult uterine sarcoma., Conclusion: Surgical practice patterns changed for our group of 8 gynecologists in the year after a laparoscopic power morcellator was withdrawn. Though open hysterectomies did not increase, no laparoscopic supracervical hysterectomies were performed. Total laparoscopic and vaginal hysterectomies and bilateral salpingectomies increased, with reliance on transvaginal uterine tissue-removal techniques. Patient outcomes including surgical infections, length of surgery, estimated blood loss and total hospital stay did not change. Our results suggest that experienced vaginal surgeons can adapt to removal of important surgical equipment and continue to provide minimally invasive hysterectomies without compromising patient outcomes and safety., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Objective: To compare the morcellation efficiency of the Wolf Piranha oscillating morcellator with the Lumenis VersaCut reciprocating morcellator., Materials and Methods: After institutional review board approval, we conducted a retrospective analysis of patients undergoing holmium laser enucleation of the prostate (HoLEP) for symptomatic benign prostatic hyperplasia. The first 41 cases of HoLEP with morcellation performed with the oscillating morcellator were matched by weight of resected tissue to 41 control patients from our historic data set who underwent morcellation with the reciprocating system. The primary outcome of interest was morcellation efficiency. We also evaluated surgeon experience level to assess for a learning curve with the oscillating morcellator., Results: The 41 patients from each group were comparable in terms of age, prostate size, continuation of aspirin, and catheter status. The oscillating morcellation efficiency was nearly double that of the reciprocating morcellator (8.6 g/min [range: 3.0-18.3] vs 3.8 g/min [range: 0.9-10.1], P <.0001). Mean resected weights for cases with the oscillating and reciprocating instruments were 69 g (range: 17-224 g) and 69 g (range: 17-213 g), respectively (P = .9). The total operative time and complication rates did not significantly differ. For the oscillating system, morcellation efficiency for cases performed by staff alone was 9.8 g/min compared with 8.1 g/min when trainees were involved (P = .2), and there was no correlation between morcellation efficiency and number of cases performed (R = 0.01)., Conclusion: The oscillating morcellation system resulted in a morcellation efficiency double that of the reciprocating system for tissue retrieval after HoLEP. Achieving efficiency with the oscillating system was not associated with a significant learning curve and was not impacted by trainee involvement., (Copyright © 2017 Elsevier Inc. All rights reserved.)

The treatment of intrauterine masses, such as endometrial polyps and leiomyomas, has undergone a technological revolution in the past few decades. Gynecologists may now choose from a variety of unipolar and bipolar resectoscopes as well as an assortment of both mechanical and bipolar hysteroscopic morcellators. We present a comparison of these technologies to better practitioners understanding of the strengths and limitations of these devices.

Introduction & Objectives: Transurethral enucleation of the prostate for the management of benign prostatic obstruction (BPO) involves two steps: the enucleation and morcellation procedure. The aim of our study was to assess the efficacy of a morcellator device using disposable and reusable blades with different settings of morcellation speed., Methods: A prospective randomized study was initiated for patients with symptomatic BPO undergoing Thulium laser enucleation of the prostate. Mechanical tissue morcellation was performed using the Piranha™ morcellator (R. Wolf, Knittlingen, Germany) with disposable or reusable blades at 850 (n = 24) or 1500 revolutions per minute (rpm) (n = 24). Patient characteristics, intraoperative complications, and the morcellation rate (g/min) were recorded. Data are expressed as median and interquartile range (IQR)., Results: Forty-eight patients were randomized using disposable (n = 24) or reusable blades (n = 24). For reusable blades, the morcellation rate did not increase when changing the morcellation speed from 850 to 1500 rpm (5 vs 4.53 g/min, p = 0.843). The morcellation rate increased significantly when changing the morcellation speed from 850 to 1500 rpm using single-use blades (4.77 vs 10 g/min, p ≤ 0.014). The morcellation rate was not different at 850 rpm between reusable and single-use blades (5 vs 4.77 g/min, p = 0.671). Conversely, the morcellation rate was significantly different at 1500 rpm between reusable and single-use blades (4.53 vs 10 g/min, p ≤ 0.017). The total morcellation rate (at 850 and 1500 rpm) was significantly increased using single-use blades compared to reusable blades (7.67 vs 4.8 g/min, p ≤ 0.026). Interestingly, enucleated weight (g) and the morcellation rate (g/min) correlated inversely using single-use blades at 1500 rpm (r = -0.742, p ≤ 0.004). Only one superficial bladder injury occurred at 1500 rpm, which needed no further interventions., Conclusions: The Piranha morcellator facilitates efficient tissue removal with single-use and reusable blades. Disposable morcellator blades increase tissue removal significantly at 1500 rpm.

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., Conclusions: 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.

Background and Objectives: The well-known advantages of minimally invasive surgery make the approach well suited for hysterectomy and other gynecological procedures. The removal of specimens excised during surgery has been a challenge that has been answered by the use of power morcellation. With this study we sought to assess the feasibility of power morcellation within a specimen bag., Methods: This was a retrospective cohort study including patients from a private practice in suburban Chicago, Illinois, who underwent contained electromechanical power morcellation during a laparoscopic or robot-assisted hysterectomy or myomectomy from May 2014 through December 2015. Contained power morcellation was performed with the Espiner EcoSac 230 (Espiner Medical Ltd., North Somerset, United Kingdom) specimen bag. Descriptive statistics were performed for both categorical and continuous data., Results: Of the 187 procedures performed, 73.8% were myomectomies, and 26.2% were hysterectomies. The patients' mean age was 40 (range, 25-54) years and mean body mass index was 28.7 (range, 17.3-57.6). The average specimen weight was 300 g, with the largest weighing 2134 g. Estimated blood loss averaged 98.4 mL. The postoperative admission rate was 12.3%, most of which were due to nausea and urinary retention. Seventeen patients (9.1%) had postoperative complications, most of which were minor, and 4 (2.1%) were readmitted. There were no bag failures or complications that were due to the use of the specimen bag or to power morcellation., Conclusions: Performing electromechanical power morcellation within the Espiner EcoSac 230 specimen bag was successfully performed in 187 patients with no bag-related complications. This method of contained power morcellation is feasible, reliable, and reproducible, even for a large specimen.

In April 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. The video and supplemental contents demonstrate the safety and feasibility of the technique., (© 2016 S. Karger AG, Basel.)

Introduction: Morcellation of intravesical adenoma (MIA) is an important part of the endoscopic enucleation procedure. The aim of this study was to analyse the learning curve of the MIA during endoscopic enucleation of the prostate., Material: We conducted a prospective study of the first 90 patients treated by endoscopic enucleation of the prostate by a single surgeon without previous experience of MIA. The population was divided into 3 consecutive groups of 30 patients. MIA was performed with the morcellator Pinranha (Wolf) and disposable blades (V max © ). The criteria selected to assess the progress of MIA over time were: duration of MIA (min), the intraoperative complications encountered during MIA and weight morcelleted tissue. The efficacy of MIA was assessed with the ratio weight specimen/MIA duration (min/g) over time., Results: The three groups were comparable in terms of age, ASA score of prostate volume. A significant decrease in the duration of MIA was found between groups 1 and 2 (12 versus 5.5min, P<0.0001), to reach a plateau in the group 3 (3min). A significant increase in the efficiency of MIA was found between group 1 and 2 (5.5 versus 11g/min, P<0.0001), to reach a plateau in the group 3 (20g/min). Bladder injuries were limited (7.7%), superficial and encountered in the early learning phase., Conclusion: In our experience, the MIA required a learning curve estimated between 30 and 60 procedures., Level of Evidence: IV., (Copyright © 2016 Elsevier Masson SAS. All rights reserved.)

Tissue morcellation during laparoscopic hysterectomy carries the risk of spreading cells from unsuspected malignancy. Contained morcellation inside a bag is supposed to minimize this risk. The present study evaluated routine use of in-bag morcellation during laparoscopic hysterectomy in a consecutive patient cohort ( n = 49). The system used was More-Cell-Safe (A.M.I. Austria). Median age was 47 (35 to 76) years and BMI 25.1 (18.8 to 39.8). Indications for hysterectomy were fibroids (71.4%), adenomyosis (16.3%), prolapse (8.2%), and bleeding disorders (4.1%). 48 (98%) patients underwent supracervical hysterectomy and 1 (2%) underwent total hysterectomy. No unsuspected malignancy occurred. Median weight of extirpated tissue was 195 g (18 to 1110). Residual tissue and/or fluid in the bag amounted to 29 g (0 to 291). Median overall duration of surgeries was 100.5 min, and median time associated with the use of the bag was 10 min (5 to 28), significantly correlated with uterine volume ( p = 0.0094) and specimen weight ( p = 0.0002), but not with patient's BMI ( p = 0.6970). Technical success rate for contained morcellation was 93.9%. Peritoneal washings after contained morcellation were all negative for malignant or smooth muscle cells.

The diagnosis of an unsuspected leiomyosarcoma after hysterectomy for the treatment of a presumed benign leiomyoma is a rare but highly clinically significant event. In order to facilitate removal of large uterine specimens using a minimally invasive surgical approach, morcellation with extraction in pieces is often performed. In the event of unsuspected malignancy, this may result in abdominal dispersion of the tumor and contribute to poorer survival. In the present article, we report a case of contained power morcellation of an unsuspected high-grade leiomyosarcoma with 2 years of follow-up. Although further study is necessary, this technique may minimize the risk that women undergoing laparoscopic hysterectomy with morcellation have a worse prognosis when diagnosed with an unexpected malignancy., (Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.)

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 >500 g performed between January 2010 and December 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 >500 g 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 >500 g 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.)

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.)

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 10.5 min (range, 7-19 min). The mean specimen weight was 191.9 g (range, 32-710 g). Mean morcellation time was 10.5 min (range, 3-28 min), mean weight of remaining tissue and fluid in the bag after morcellation was 12.1 g (range, 7-19 g)., Conclusions: 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.

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.

The Food and Drug Administration (FDA) is classifying the gynecologic laparoscopic power morcellation containment system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the gynecologic laparoscopic power morcellation containment system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

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.)

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-bag morcellation 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.

Objective: To evaluate whether manualin-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 scale), intraoperative blood loss, rate of complications, and postoperative outcomes., Result(s): A sample size of 51 per group (n = 102) was planned. Between March 2014 and January 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(s): 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., Clinical Trial Registration: NCT02086435., (Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To determine prognostic factors associated with cold-knife morcellation during vaginal hysterectomy., Methods: We conducted a retrospective cohort study evaluating all consecutive patients undergoing a vaginal hysterectomy between January 1, 2009, and August 31, 2014. The primary outcome was the utilization of uncontained vaginal morcellation performed using cold-knife wedge resection at the time of vaginal hysterectomy. Secondary outcomes included perioperative data. Significant factors were included in a multivariate logistic regression model to the binary variable vaginal morcellation at the time of vaginal hysterectomy., Results: A total of 743 women met study inclusion criteria and underwent vaginal hysterectomy with intact uterine removal (n=383) or with uterine morcellation (n=360) with and without other vaginal procedures. A nonparametric Wilcoxon-rank-sum test and χ test were used to compare the cohorts of patients with and without morcellation. Characteristics associated with significantly increased likelihood of morcellation included younger age, non-Caucasian race, American Society of Anesthesiologists class 1 or 2, lower parity, lower number of prior vaginal deliveries, absence of prolapse, presence of leiomyoma, and an enlarged uterus. A multivariate logistic model utilizing factors most likely associated with morcellation revealed lack of prolapse (adjusted odds ratio [OR] 3.87, P<.001), leiomyoma (adjusted OR 2.77, P=.035), and larger uterine weight (adjusted OR 7.25, P<.001) increased the likelihood of morcellation. Prior vaginal delivery was associated with a decreased likelihood of morcellation (adjusted OR 0.79, P=.005)., Conclusion: Vaginal hysterectomy with morcellation is associated with the following factors: absence of prior vaginal delivery, absence of prolapse, presence of leiomyoma, and a uterus larger than normal size.

The U.S. Food and Drug Administration (FDA) is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for the treatment of leiomyomas because of the concern for inadvertent spread of tumor cells if an undiagnosed cancer were present. The authors, representing a 45-member review group, reviewed the current literature to formulate prevalence rates of leiomyosarcoma in women with presumed leiomyomas and to asses reliable data regarding patient survival after morcellation. The authors disagree with the FDA's methodology in reaching their conclusion and provide clinical recommendations for care of women with leiomyomas who are planning surgery.

Minimally invasive surgery (MIS) is increasingly being used to treat uterine fibroids because of the significant patient and societal benefits of these techniques over traditional laparotomy. Morcellation affords the removal of large fibroids in MIS but carries the risk of disseminating occult malignant tissue. The benefits of MIS for treating fibroids must be carefully weighed against its risks of morcellation., (© 2015 Wiley Periodicals, Inc.)