Inbag Morcellation Applied to the Laparoscopic Surgery of Leiomyoma: A Randomized Controlled Trial.

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.

In-bag manual versus uncontained power morcellation for laparoscopic myomectomy.

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.

Laparoscopic myomectomy using self-made retrieval bag to contain tissue extraction.

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.

Medicolegal Issues in Power Morcellation: Cautionary Rules for Gynecologists to Avoid Unfavorable Outcomes.

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.

Ultrasound-guided Morcellation During Difficult Holmium Laser Enucleation of the Prostate.

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.

In Vitro Leakage Testing of Tissue Containment Bags When Subjected to Power Morcellation Forces.

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.

A national survey: Evaluating current practice and risk assessment in morcellation amongst gynaecologists in the United Kingdom.

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.

The impact of recent power morcellator risk information on inpatient surgery and patient outcomes.

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.

The Morcellation "Debate" and the FDA 510(k) Process-A Call for Further Reform.

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.

Two-port myomectomy using bag-contained manual morcellation: A comparison with three-port myomectomy using power morcellation.

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.

The ex vivo and in vivo Characteristics of New DrillCutTM Prostate Morcellator after Holmium Laser Enucleation of the Prostate: A Pilot Study.

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.

Cell Spillage after Contained Electromechanical Morcellation Using a Specially Designed In-Bag System for Laparoscopic Myomectomy: Prospective Cohort Pilot Study.

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.

Feasibility of myomatous tissue extraction in laparoscopic surgery by contained in - bag morcellation: A retrospective single arm study.

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.

Comparison of the Technical Feasibility and Safety of Three Contained Morcellation Techniques: A Pilot Study in an Animal Model.

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 CO2 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. CO2 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 CO2 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.

Development and Evaluation of a Novel Endoscopic Sack to Facilitate Tissue Prostate Adenoma Morcellation.

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.

Hysteroscopic myomectomy: a comparison of techniques and review of current evidence in the management of abnormal uterine bleeding.

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.

The prevalence of occult leiomyosarcoma in women undergoing presumed fibroid surgery and outcomes after morcellation.

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.

Development and history of morcellators.

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.