In-bag abdominal manual morcellation versus contained power morcellation in laparoscopic myomectomy: a comparison of surgical outcomes and costs.

BACKGROUND: To compare the surgical outcomes and costs of in-bag abdominal manual morcellation (AMM) and contained power morcellation (PM) in laparoscopic myomectomy. METHODS: A total of 61 patients were divided into two groups based on their myomectomy specimen extraction methods: AMM group (n = 33) and electromechanical contained PM group (n = 28). The surgical outcomes and cost were compared between groups. During AMM, a glove bag (in 27 patients) and an endo bag were used (in 6 patients) according to the myoma size. RESULTS: Morcellation time (18 ± 9.2 min vs. 37.4 ± 14.1 min) and total operation time (100 ± 24.3 min vs. 127 ± 33.1 min) were significantly lower in the AMM group compared to those in the PM group. Other surgical outcomes, which were similar between groups, included delta hemoglobin, length of hospital stay and VAS score at 12 and 24 h postoperatively. There were no per- or postoperative complications in both group with no conversion to laparotomy. One patient was transfused with two units of erythrocyte suspension postoperatively in the PM group. Sarcoma was not diagnosed in any of the cases in both group. CONCLUSION: The in-bag AMM or contained PM for specimen extraction resulted in similar outcomes in terms of delta hemoglobin, postoperative pain intensity (VAS score at 12 and 24 h postoperatively), the need for additional analgesia, and the length of hospital stay; however, total operation time and morcellation time were significantly shorter in the AMM group, indicating a prominent advantage. Significant cost-effectiveness is also a critical advantage of in-bag AMM compared to containing PM.

To Laparoscopically Preserve Fertility in Intraabdominal Giant Myoma with Application of Contained In-Bag Morcellation: Mission Impossible?

A technical video was produced to demonstrate in step-by-step fashion a multiple contained myomectomy of a 20 × 30 cm giant myoma and seven additional fibroids found in the same patient, which required two different types of specimen retrieval bags for the electronic power morcellation. This complete surgical procedure included leiomyomata enucleation, contained in-bag electronic power morcellation, uterine reconstruction and the application of an adhesion prophylactic medical product.

Laparoscopic Power Morcellation: Techniques to Avoid Tumoral Spread.

STUDY OBJECTIVE: To show 3 different techniques for achieving an endobag morcellation without adding extra time and cost to the surgery. DESIGN: Stepwise demonstration of the 3 techniques with narrated video footage. SETTING: Morcellation is a useful procedure for fragmenting and extracting specimens during laparoscopic surgery without the need to perform a laparotomy. Patients who otherwise would not be eligible for minimally invasive surgery (i.e., those with a large uterus or myomas) could benefit from laparoscopic advantages. However, morcellation has a major limitation: the risk of dissemination of unsuspected malignancies. In 2017, the Food and Drug Administration released an updated assessment of the use of laparoscopic power morcellators for treatment of leiomyomas. A total of 23 studies were included in the analysis, and 20 studies (90 910 women) contributed to the estimated prevalence of leiomyosarcoma at the time of surgery for presumed leiomyomas. Depending on the modeling methodology used, the estimated prevalence of uterine sarcoma was 1 in 305 to 1 in 360 women, and for leiomyosarcoma, the estimated prevalence was 1 in 570 to 1 in 750 women [1]. Currently available evidence has suggested that if an undiagnosed uterine malignancy is intra-abdominally morcellated, there is a risk of intraperitoneal dissemination of the disease [2]. Therefore, the European Society of Gynecological Oncology emitted a statement in 2016 recommending avoiding morcellation if there is any suspicion of sarcoma and using endobag containers for morcellation of the surgically removed uterine myomas [3]. In addition, in the United States, the Food and Drug Administration recommends performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment system, legally marketed in the United States [4]. INTERVENTIONS: There are several techniques described in the literature for contained uterine myomas morcellation [5]. In this video, we present 3 of them: First, an indirect-view morcellation is described. In this technique, we placed the myoma in the bag and exteriorize it through one of the trocars. Once outside the abdomen, we placed the morcellator through the bag opening and did the morcellation inside the bag while checking through the umbilicus camera. Special attention must be paid to avoid any damage to the bag because the visualization is limited in this technique. Second, a direct-view technique is described, in which we exteriorized the opening of a 15-mm bag through the suprapubic trocar and a closed end of the bag through the umbilicus. We made a hole in the umbilicus end of the bag and introduced the camera trocar through it. Once done, we introduced the morcellator through the opening and the camera in the umbilicus port. Third, a single-port-contained morcellation is explained. The bag was exteriorized through the umbilicus, and a skin retractor was placed. A glove was placed outside the retractor to isolate the bag. Once placed, 2 of the fingers were opened and used as trocars (one for the morcellator and the other for a 30° camera). After using this technique, the scope should be replaced to minimize the risk of contamination. The following are possible limitations of each technique: in the indirect-view technique, owing to the limited visualization, the surgeon must pay special attention to avoid tearing the bag while morcellating the specimen. In the direct-view technique method, the surgeon needs to ensure the proper closure of the bag before removing it from the abdomen to avoid possible dissemination risk. Finally, in the single-port technique, the surgeon must have previous experience in this type of approach, minimizing the risk of contamination by changing the scope after the morcellation process. CONCLUSION: Laparoscopic power morcellation may provide several benefits for our patients, when performing a hysterectomy or a multiple myomectomy. We presented 3 different and feasible techniques for laparoscopic power morcellation using an endobag container.

A Case of Unsuspected Low-grade Endometrial Stromal Sarcoma Successfully Treated with Two Minimally Invasive Surgeries.

It is relatively uncommon to treat patients with a preoperative diagnosis of benign leiomyoma that is then unexpectedly rediagnosed as malignant in postoperative histology. We report the case of a 55-year-old woman with low-grade endometrial stromal sarcoma who had been diagnosed as having uterine leiomyoma with myxoid degeneration by preoperative magnetic resonance imaging (MRI). She underwent a laparoscopic hysterectomy. The uterus, after being placed in a retrieval bag, was transvaginally morcellated to prevent spillage of the contents, as the MRI image appeared somewhat atypical. A retrospective survey of MRI findings affirmed that the muscle tissue had the appearance of a low-intensity band-like structure: bag of worms appearance. She underwent a laparoscopic bilateral salpingo-oophorectomy and remains recurrence-free. With somewhat atypical preoperative MRI, it is essential to prevent the spillage of the tumor content as no definitive preoperative exclusion of unsuspected mesenchymal malignancies is feasible.

The Medical Device Applied to Uterine Fibroids Morcellation: Analysis of Critical Biological Issues and Drawbacks from A Medical-Legal Prospective.

Following the FDA safety communication of 2014 increasing attention has been to the treatment of uterine fibroids, due to the suspicion of a potential leiomyosarcoma (ULM). FDA banned the use of power morcellation in the US, since this technique is likely to spread malignant cells from an unsuspected ULM. We criticized the medical legal consequences of this banning among gynecologists and patients, focusing on the drawbacks of biology and surgery. The authors analyzed literature data on one side, on the incidence, diagnosis and treatment of leiomyoma and ULM, and the other side, on the power morcellations and related critical issues, trying to highlight their main controversial aspects and to outline the possible impact on patients and on medical responsibility. The alternative methods to power morcellation are more invasive surgical solutions (as mini laparotomy or culdotomy), which inevitably involve associated risks with the surgical procedure as such and always request the containing bags. Although the in-bag morcellation is a promising technique, currently the used devices are largely off-label. This highlights the surgical risk, in case of complications, of suffering for malpractice claims both for not having used a containment system, favoring the spread of the neoplasm, and for its off-label use. Since the diagnosis of ULM is by histology after surgery, the fear of legal consequences or medical malpractice for unknown ULM power morcellation, should be targeted to analyze, in terms of cost/benefit ratio, the surgical priority. It should focus on the prevention of the risk of having a rare and statistically limited ULM or on the surgical-related complications, often linked to a slowdown minimally invasive surgery, or on the use of the authorized in-bag morcellations.

Laparoscopic In-Bag Morcellation Compared with Conventional Morcellation of Myomas and Uterus with Myomas.

STUDY OBJECTIVE: To evaluate contained bag electromechanical morcellation for removal of myomas and uterus with myomas, laparoscopically (Study group B), and compare it with uncontained laparoscopic morcellation (Control group A) in patients with similar parameters done earlier. DESIGN: Retrospective Cohort Comparative Study (Canadian Task Force 2-1). SETTING: Advanced Gynaecologic MAS, university recognized tertiary centre, Mumbai, India. PATIENTS: 720 women had laparoscopic removal of myomas or large uterus with myomas during a study period of 6 years (from 13 May 2012 to 14 August 2018) with contained bag electromechanical or conventional morcellation. INTERVENTIONS: Laparoscopic hysterectomy, laparoscopic myomectomy, conventional uncontained morcellation, contained in-bag morcellation. MAIN OUTCOMES MEASURES: Laparoscopic contained in-bag morcellation was compared with conventional morcellation of myomas and uterus with large myomas during a study period of 6 years. Parameters assessed were operating time, time for insertion of bag, morcellation of tissues and removal of bag, blood loss, complications, conversion to open surgery and histopathologic findings of tissues. In Group A, in the first 3 years, 355 women underwent uncontained morcellation. Myoma size and weight varied from 5 cm to 26 cm and 200 g to 3740 g respectively. The myoma number ranged from 1 to 18. No case of leiomyosarcoma was reported. In Group B, in the next 3 years, 365 women underwent contained bag morcellation in 196 myomectomy cases and 169 hysterectomy cases. Myoma size and weight varied from 4 cm to 20 cm and 200 g to 2100 g respectively. The number of myomas varied from 1 to 17. RESULTS AND CONCLUSION: Laparoscopic contained bag morcellation for myomas and uterus with large myomas were evaluated. In myomectomy group both conventional and in bag laparoscopic morcellation were comparable in terms of duration of the surgery and blood loss. When all cases ( hysterectomy and myomectomy combined together) and cases of hysterectomy with large fibroid were studied, laparoscopic in bag morcellation took less operative time and there was statistically significant difference in operative time . No case of leiomyosarcoma was found in our study of 720 cases of myomas or uterus with large myomas.

Pyomyoma After Uterine Artery Embolization: Laparotomy Avoided by In-Bag Morcellation.

We report a case of a pyomyoma in which in-bag morcellation allowed for a total laparoscopic hysterectomy instead of laparotomy, which has been recognized as the standard of care to avoid the spread of infection from morcellation. A 45-year-old multiparous woman presented with sepsis, pelvic pain, and leukocytosis at 1 month after undergoing uterine artery embolization for symptomatic uterine leiomyoma. Pelvic computed tomography scan revealed a 9-cm suspected pyomyoma. A total hysterectomy was performed using a laparoscopic approach with in-bag morcellation. The intervention was successful, and the postoperative course was uneventful. The patient was discharged on postoperative day 1 and was well at 2 months after surgery.

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.

Contained Morcellation: Review of Current Methods and Future Directions.

Power morcellation of surgical specimen during laparoscopic surgery is a practical technology that provides the opportunity to perform several minimally invasive procedures. However, this technology brought forward additional risks and complications associated with dissemination of both benign and malignant tissues inside the abdominal cavity. Based on startling cases, Food and Drug Administration (FDA) announced a discouraging statement on the use of power morcellators that decreased the number of minimally invasive approaches in the following period. As a response to these concerns and negative impacts of the FDA statement, researchers developed several new approaches resulting in contained or in-bag morcellation methods. In this review, we aimed to discuss these current methods and provide an insight for future developments.

Preclinical safety testing for morcellation and extraction for an endobag with sealable ports: in vitro pilot study.

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.

Power morcellation inside a secure endobag: a pilot study.

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.

In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial.

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.

First clinical experiences using a new in-bag morcellation system during laparoscopic hysterectomy.

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.

Contained tissue extraction using power morcellation: prospective evaluation of leakage parameters.

BACKGROUND: Safe tissue removal is a challenge for minimally invasive procedures such as myomectomy, supracervical hysterectomy, or total hysterectomy of a large uterine specimen. There is concern regarding disruption or dissemination of tissue during this process, which may be of particular significance in cases of undetected malignancy. Contained tissue extraction techniques have been developed in an effort to mitigate morcellation-related risks. OBJECTIVE: The objective of the study was to quantify perioperative outcomes of contained tissue extraction using power morcellation, specifically evaluating parameters of tissue or fluid leakage from within the containment system. STUDY DESIGN: This was a study including a multicenter prospective cohort of adult women who underwent minimally invasive hysterectomy or myomectomy using a contained power morcellation technique. Blue dye was applied to the tissue specimen prior to removal to help identify cases of fluid or tissue leakage from within the containment system. RESULTS: A total of 76 patients successfully underwent the contained power morcellation protocol. Mean time for the contained morcellation procedure was 30.2 minutes (±22.4). The mean hysterectomy specimen weight was 480.1 g (±359.1), and mean myomectomy specimen weight was 239.1 g (±229.7). The vast majority of patients (73.7%) were discharged home the same day of surgery. Final pathological diagnosis was benign in all cases. Spillage of dye or tissue was noted in 7 cases (9.2%), although containment bags were intact in each of these instances. CONCLUSION: Findings are consistent with prior work demonstrating the feasibility of contained tissue extraction; however, further refinement of this technique is warranted.

A new in-bag system to reduce the risk of tissue morcellation: development and experimental evaluation during laparoscopic hysterectomy.

INTRODUCTION: Minimal invasive approaches have proven beneficial for patients undergoing myomectomy and hysterectomy, but necessary tissue morcellation carries the risk of cell dissemination in rare cases of inadvertent malignancy. Performing the morcellation process within a contained bag system may prevent spilling and therefore enhance safety of the laparoscopic procedures. MATERIAL AND METHODS: The present study describes the development and experimental evaluation of a new bag system in vitro and in vivo in a pig model of laparoscopic supracervical hysterectomies. RESULTS: The main results on n = 8 procedures with in-bag morcellation compared to n = 8 controls without bag indicate reproducible feasibility and protective effect of the new bag, which is the first published to our knowledge that does not require puncturing in a standard multiport laparoscopy setting. Overall surgery time was significantly prolonged in the bag group by 12.86 min (P = 0.0052; 95 % confidence interval 4.64-21.07), but peritoneal washings were negative for muscle cells in all cases with bag use, compared to positive cytology in 5/8 cases without bag (P = 0.0256). CONCLUSION: Clinical trials will now be necessary to investigate the reproducibility of these encouraging data in human application.

Open power morcellation versus contained power morcellation within an insufflated isolation bag: comparison of perioperative outcomes.

STUDY OBJECTIVE: To compare perioperative outcomes, particularly operative time, between uncontained and in-bag power morcellation of uterine tissue at the time of laparoscopic surgery. DESIGN: Canadian Task Force classification II-3. SETTING: Academic tertiary care hospitals. PATIENTS: Women undergoing laparoscopic hysterectomy or myomectomy who required morcellation of uterine tissue for specimen extraction. INTERVENTIONS: Outcomes among patients who had in-bag power morcellation were compared with outcomes among patients who had traditional power morcellation. The technique for in-bag morcellation entails placing the specimen into a large containment bag within the abdomen, insufflating the bag within the peritoneal cavity, and then using a power morcellator to remove the specimen from inside the bag. MEASUREMENTS AND MAIN RESULTS: The cohort consisted of 85 consecutive patients who underwent surgery with morcellation of uterine tissue. Prospective data collected from 36 patients who underwent in-bag morcellation were compared with retrospective data collected from the immediately preceding 49 patients who had uncontained power morcellation. Baseline demographics were comparable between the 2 groups although women who underwent in-bag morcellation were on average older than the open morcellation group (mean age in years [standard deviation], 49.19 [1.12] vs 44.06 [8.93]; p = .01). The mean operating room time was longer in the in-bag morcellation group (mean time in minutes [standard deviation], 119.0 [55.91] vs 93.13 [44.90]; p = .02). The estimated blood loss, specimen weight, hospital length of stay, and perioperative complication rate did not vary between the 2 groups. Operative times did not vary significantly by surgeon. There were no cases of malignancy or isolation bag disruption. CONCLUSIONS: In-bag power morcellation, a tissue extraction technique developed to reduce the risk of tissue dissemination, results in perioperative outcomes comparable with the traditional laparoscopic approach. In this cohort, the mean operative time was prolonged by 26 minutes with in-bag morcellation but may potentially be reduced with further refinement of the technique.