Risk of leakage with a new tissue containment system for power morcellation during gynecologic laparoscopy: An in vitro study

Purpose To evaluate leakage and tissue dissemination associated with a new tissue containment system for tissue removal during laparoscopic myomectomy morcellation using rigid pipes that can be seamlessly connected to detachable trocars. Methods Pork specimens were stained with indigo carmine dye and morcellated under laparoscopic guidance in a plastic trainer box. Morcellation was performed using two different containment systems. First, a polyurethane bag, 12 mm sheath for introduction into the peritoneal cavity, and 11 mm optic sleeve (control group). Second, a new tissue containment system using rigid pipes and detachable trocars (experimental group). All bags were inflated to 14–20 mmHg pressure using a standard CO2 insufflator. Visual evidence of spilled tissue or dye and procedure times were recorded. Results Thirty trials were performed using a multi-port approach and the two tissue containment systems. The leakage rate was 0.03% for the experimental group and 26.6% for the control group (p < 0.005). Morcellation time was significantly shorter in the experimental group compared to that in the control group (p < 0.05). Mean bag introduction and removal times of the experimental group were shorter than those of the control group; however, the removal time differences were not statistically significant. Conclusion The current study quantified leakage during morcellation and the convenience provided by a new tissue containment system. Further studies and clinical trials are needed to corroborate the findings and to evaluate the use of the new tissue containment system for minimally invasive surgical treatment of tumors.

Preclinical safety testing and initial experience of a morcellation bag with four sealable ports

Electromechanical morcellation—so called power morcellation—is a minimally invasive approach to remove bulky lesions such as uterine fibroids. The spread of benign and malignant tissue due to morcellation is a major concern that might limit the use of laparoscopic interventions. We present an in vitro evaluation of the safety characteristics of a four-port endobag with closable trocar sleeves, and describe physical properties of the bag that may or may not allow passage through the hole. In addition, we report our preliminary experience of this tool when used for laparoscopic supracervical hysterectomies. The behavior of the endobag during the extraction process was analyzed by extracting opened and re-sealed bags filled with 20 ml blue dye solution through a wooden template, with incisions measuring 10 to 24 mm. The endobag was used in 50 subtotal hysterectomies during the morcellation procedure. In the in vitro test, no dye loss was recorded for incisions measuring 11–24 mm. The mean force required to pull the bag through the template was inversely proportional to incision size. No bag rupture occurred during the surgical procedures. The mean time taken to prepare the bag for morcellation was 7.1 min (range, 4–14 min), the mean duration of subtotal hysterectomy was 53.4 min (range, 20–194 min). The mean weight of the removed body of the uterus was 113.8 g (range, 13–896 g), the mean weight of tissue and fluid remaining in the bag after morcellation 7.9 g (range, 0–39 g). In the in vitro setting, the improved endobag signifies greater patient safety during bag extraction, along with less tissue traumatization due to a smaller incision in the abdominal wall. The improved ergonomic features of the bag permit the insertion of three trocars in the lower abdomen and avoid closure of unused access ports. Our preliminary experience has shown that the device can be used under routine conditions. Failure rates will be evaluated in future studies.

Late presentation of extrauterine adenomyomas after laparoscopic morcellation at hysterectomy: a case report

Background An adenomyoma is a well circumscribed form of adenomyosis and can be located within the myometrium, in the endometrium as a polyp, or extrauterine with the last being the rarest presentation amongst the three. With the ongoing advancement in gynecological surgery, the use of electromechanical morcellators have made the removal of large and dense specimens possible with minimally invasive techniques. However, it has also caused an increase in complications which were previously rare. Whilst the tissue is being grinded within the abdominal cavity, residual tissue can spread and remain inside, allowing for implantation to occur and thereby giving rise to recurrence of uterine tissue as a new late postoperative complication. Case presentation A 45-year-old woman presented with worsening constipation and right iliac fossa pain. Her past surgical history consists of laparoscopic supra-cervical hysterectomy that was indicated due to uterine fibroids. Computerized tomography and magnetic resonance imaging were done, which showed an irregular lobulated heterogeneous mass seen in the presacral space to the right, located on the right lateral aspect of the recto-sigmoid, measuring 4.5 × 4.3 × 4.3 cm in size. A transvaginal ultrasound revealed a cyst in the left ovary. The patient had a treatment course over several months that included Dienogest (progestin) and Goserelin (GnRH analogue) with add-back therapy. In line with the declining response to medications, the patient was advised for a laparoscopic ovarian cystectomy. During the surgery, an additional lesion was found as a suspected fibroid and the left ovarian cyst was identified as pockets of peritoneal fluid which was sent for cytology. The surgical pathology report confirmed adenomyosis in both specimens, namely the right mass and the initially suspected fibroid. Conclusion In this case report, we showcase a rare occurrence of an extrauterine adenomyoma presenting two years post laparoscopic morcellation at hysterectomy. This poses questions regarding the benefits versus risks of power morcellation in laparoscopic hysterectomy.

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.

Appraisal of national and international uterine fibroid management guidelines: a systematic review

Background Guidelines standardise high-quality evidence-based management strategies for clinicians. Uterine fibroids are a highly prevalent condition and may exert significant morbidity. Objectives The purpose of this study was to appraise national and international uterine fibroid guidelines using the validated AGREE-II instrument. Selection Strategy An electronic database search of PubMed and EMBASE from inception to October 2020 for all published English-language uterine fibroid clinical practice guidelines was undertaken. Data Collection and Analysis 939 abstracts were screened for eligibility by two reviewers independently. Three reviewers used the AGREE-II instrument to assess guideline quality in six domains (scope and purpose, stakeholder involvement, rigour of development, clarity of presentation, applicability, and editorial independence). Recommendations were mapped to allow a narrative synthesis regarding areas of consensus and disagreement. Main Results Eight national (AAGL, SOGC 2014, ACOG, ACR, SOGC 2019, CNGOF, ASRM, and SOGC 2015) and one international guideline (RANZOG) were appraised. The highest scoring guideline was RANZOG 2001(score 56.5%). None of the guidelines met the a priori criteria for being high-quality overall (score >= 66%). There were 166 recommendations across guidelines. There were several areas of disagreement and uncertainty. Conclusions There is a need for high-quality fibroid guidelines given heterogeneity across individuals and a large range of treatment modalities available. There are also areas of controversy in the management of fibroids (e.g. Ulipristal acetate, power morcellation) which also should be addressed in any guidelines. Future guidelines should be methodologically robust to allow high-quality decision-making regarding fibroid treatments.

Preoperative MRI and LDH in women undergoing intra-abdominal surgery for fibroids: Effect on surgical route

Introduction Our institution implemented a preoperative protocol to identify high-risk cases for which power morcellation should be avoided. Material and methods In this retrospective cohort study, an institutional protocol requiring preoperative Magnetic Resonance Imaging with diffusion-weighted imaging and serum Lactate Dehydrogenase levels was implemented. Chart review was performed including all women who underwent intra-abdominal surgery for symptomatic fibroids from 4/23/2013 to 4/23/2015. Results A total of 1,085 women were included, 479 before and 606 after implementation of the Magnetic Resonance Imaging / Lactate Dehydrogenase protocol. The pre-protocol group had more post-menopausal women (4% vs. 2%, p = 0.022) and women using tamoxifen (2% vs. 0%, p = 0.022) than those in the post-protocol group, but baseline patient characteristics were otherwise similar between groups. Incidence of malignant pathological diagnoses did not change significantly over the time period in relation to protocol implementation. The rate of open surgery for both hysterectomy and myomectomy remained the same in the year preceding and the year following initiation of the protocol (open hysterectomy rate was 19% vs. 16% in pre- and post-protocol groups, respectively, P = 0.463, and open myomectomy rate was 10% vs. 9% rates in pre- and post-protocol groups, respectively, P = 0.776). There was a significant decrease in the use of power morcellation (66% in pre- and 50% in post-protocol cohorts, p<0.001) and an increased use of containment bags (1% in pre- and 19% in post-protocol cohort). When analyzing the subset of women who had abnormal Magnetic Resonance Imaging / and Lactate Dehydrogenase results, abnormal Magnetic Resonance Imaging results alone resulted in higher rates of open approach (65% for abnormal vs. 35% for normal). Similarly, a combination of abnormal Magnetic Resonance Imaging and Lactate Dehydrogenase tests resulted in higher rates of open approach (70% for abnormal and 17% for normal). Abnormal Lactate Dehydrogenase results alone did not influence route. Conclusions Rates of MIS procedures were decreased for women with abnormal preoperative Magnetic Resonance Imaging results. False positive results appear to be one of the main drivers for the use of an open surgical route.