Objective: To estimate the risk of uterine leiomyosarcoma in patients undergoing gynecological surgery and also to identify groups at risk for unrecognized uterine leiomyosarcoma. Methods: A national cohort study was performed evaluating all uterine leiomyosarcoma (ULMS) diagnosed in The Netherlands between January 2000 and September 2015. Cases were identified and supplied by the nationwide network and registry of histo- and cytopathology in The Netherlands (PALGA). Unexpected and expected ULMS were compared. Approval for this study was granted by the Medical Ethics Committee of all participating hospitals and by the review board of PALGA. Results: 262 original cases were included. The overall incidence of ULMS in our study was 0.25% or 1:400 patients. The incidence of unexpected ULMS was 0.12% or 1:865 patients. Preoperatively, a malignancy was unexpected in 46% of the cases and expected in 54%. Abnormal uterine bleeding constituted most of the symptoms. 90% of women underwent abdominal hysterectomy and/or bilateral salpingo-oophorectomy. Conclusions: Leiomyosarcoma are rare. Women aged 40–50 years with abnormal uterine bleeding are most at risk for unexpected ULMS. In contrast, this risk is low in postmenopausal women. ULMS were highly uncommon in women aged under 40 years.

@en

Background: To assess potential risks of new surgical procedures and devices before their introduction into daily practice, a prospective risk inventory (PRI) is a required step. This study assesses the applicability of the Health Failure Mode and Effects Analysis (HFMEA) as part of a PRI of new technology in minimally invasive gynecologic surgery. Methods: A reference case was defined of a patient with presumed benign leiomyoma undergoing a laparoscopic hysterectomy or myomectomy including in-bag power morcellation; however, pathology defined a stage I uterine leiomyosarcoma. Using in-bag morcellation as a template, a HFMEA was performed. All steps of the in-bag morcellation technique were identified. Next, the possible hazards of these steps were explored and possible measures to control these hazards were discussed. Results: Five main steps of the morcellation process were identified. For retrieval bags without openings to accommodate instruments inside the bag, 120 risks were identified. Of these risks, 67 should be eliminated. For containment bags with openings 131 risks were identified of which 68 should be eliminated. Of the 10 causes most at risk to cause spillage, two can be eliminated by using appropriate bag materials. Myomectomy appears to be more at risk for residual tissue spillage compared to total hysterectomy. Conclusion: The HFMEA has provided important new insights regarding potential weaknesses of the in-bag morcellation technique, particularly with respect to hazardous steps in the morcellation process as well as requirements that bags should meet. As such, this study has shown HFMEA to be a valuable method that identifies and quantifies potential hazards of new technology.@en

Objectives: To compare uterine-sparing treatment options for fibroids in terms of reintervention risk and quality of life. Design: Systematic review and meta-analysis according to PRISMA guidelines. Setting: Not applicable. Patient(s): Women with uterine fibroids undergoing a uterine-sparing intervention. Interventions(s): Not applicable. Main Outcome Measure(s): 1) Reintervention risk after uterine-sparing treatment for fibroids after 12, 36, and 60 months; and 2) quality of life outcomes, based on validated questionnaires. Two separate analyses were performed for the procedures that used an abdominal approach (myomectomy, uterine artery embolization [UAE], artery ligation, high-intensity focused ultrasound [HIFU], laparoscopic radiofrequency ablation [RFA]) and for the procedures managing intracavitary fibroids (hysteroscopic approach, including hysteroscopic myomectomy and hysteroscopic RFA). Result(s): There were 85 articles included for analysis, representing 17,789 women. Stratified by treatment options, reintervention risk after 60 months was 12.2% (95% confidence interval [CI] 5.2%–21.2%) for myomectomy, 14.4% (95% CI 9.8%–19.6%) for UAE, 53.9% (95% CI 47.2%–60.4%) for HIFU, and 7% (95% CI 4.8%–9.5%) for hysteroscopy. For the other treatment options, no studies were available at 60 months. For quality of life outcomes, symptoms improved after treatment for all options. The HIFU procedure had the least favorable outcomes. Conclusion(s): Despite the substantial heterogeneity of the study population, this meta-analysis provides valuable information on relative treatment efficacy of various uterine-sparing interventions for fibroids, which is relevant when counseling patients in daily practice. Furthermore, this study demonstrates that long-term data, particularly for the newest uterine-sparing interventions, are urgently needed.

@en

Objective: The aim of this study was to review musculoskeletal disorder (MSD) prevalence among surgeons performing minimally invasive surgery. Background: Advancements in laparoscopic surgery have primarily focused on enhancing patient benefits. However, compared with open surgery, laparoscopic surgery imposes greater ergonomic constraints on surgeons. Recent reports indicate a 73% to 88% prevalence of physical complaints among laparoscopic surgeons, which is greater than in the general working population, supporting the need to address the surgeons' physical health. Methods: To summarize the prevalence of MSDs among surgeons performing laparoscopic surgery, we performed a systematic review of studies addressing physical ergonomics as a determinant, and reporting MSD prevalence. On April 15 2016, we searched Pubmed, EMBASE, the Cochrane Library, Web of Science, CINAHL, and PsychINFO. Meta-analyses were performed using the Hartung-Knapp-Sidik-Jonkman method. Results: We identified 35 articles, including 7112 respondents. The weighted average prevalence of complaints was 74% [95% confidence interval (95% CI) 65-83]. We found high inconsistency across study results (I 2 = 98.3%) and the overall response rate was low. If all nonresponders were without complaints, the prevalence would be 22% (95% CI 16-30). Conclusions: From the available literature, we found a 74% prevalence of physical complaints among laparoscopic surgeons. However, the low response rates and the high inconsistency across studies leave some uncertainty, suggesting an actual prevalence of between 22% and 74%. Fatigue and MSDs impact psychomotor performance; therefore, these results warrant further investigation. Continuous changes are enacted to increase patient safety and surgical care quality, and should also include efforts to improve surgeons' well-being.

@en

BACKGROUND: New technology should be extensively tested before it is tried on patients. Unfortunately representative models are lacking. In theory, fresh frozen human cadavers are excellent models.

OBJECTIVE: To identify strengths and weaknesses of fresh frozen human cadavers as research models for new technology prior to implementation in gynecological surgery.

METHODS: During pre-clinical validation studies regarding the MobiSep uterine manipulator, test procedures were performed on fresh frozen cadavers. Both the experimental setup as the performance of the prototype were assessed.

RESULTS: Five tests including six human cadavers were performed. Major changes were made to the MobiSep prototype design. The cadavers of two tests closely resembled surgical experiences as found in live patients. The anatomy of 4 of the 6 cadavers was not fully representative due to atrophy of the internal genitalia caused by age and due to the presence of pathology such extensive tumorous tissue.

CONCLUSION: The cadaver tests provided vital information regarding design and functionality, that failed to emerge during the in-vitro testing. However, experiments are subject to anatomical uncertainties or restrictions. Consequently, the suitability of a cadaver should be carefully assessed before it is used for testing new technology.

@en