Objective: To evaluate if immediate catheter removal (ICR) after laparoscopic hysterectomy is associated with similar retention outcomes compared with delayed removal (DCR). Study design: Non-inferiority randomised controlled trial. Population: Women undergoing laparoscopic hysterectomy in six hospitals in the Netherlands. Methods: Women were randomised to ICR or DCR (between 18 and 24 hours after surgery). Primary outcome: The inability to void within 6 hours after catheter removal. Results: One hundred and fifty-five women were randomised to ICR (n = 74) and DCR (n = 81). The intention-to-treat and per-protocol analysis could not demonstrate the non-inferiority of ICR: ten women with ICR could not urinate spontaneously within 6 hours compared with none in the delayed group (risk difference 13.5%, 5.6–24.8, P = 0.88). However, seven of these women could void spontaneously within 9 hours without additional intervention. Regarding the secondary outcomes, eight women from the delayed group requested earlier catheter removal because of complaints (9.9%). Three women with ICR (4.1%) had a urinary tract infection postoperatively versus eight with DCR (9.9%, risk difference −5.8%, −15.1 to 3.5, P = 0.215). Women with ICR mobilised significantly earlier (5.7 hours, 0.8–23.3 versus 21.0 hours, 1.4–29.9; P ≤ 0.001). Conclusion: The non-inferiority of ICR could not be demonstrated in terms of urinary retention 6 hours after procedure. However, 70% of the women with voiding difficulties could void spontaneously within 9 hours after laparoscopic hysterectomy. It is therefore questionable if all observed urinary retention cases were clinically relevant. As a result, the clinical advantages of ICR may still outweigh the risk of bladder retention and it should therefore be considered after uncomplicated laparoscopic hysterectomy. Tweetable abstract: The advantages of immediate catheter removal after laparoscopic hysterectomy seem to outweigh the risk of bladder retention.

@en

The aim of this study was to evaluate the catheterisation regimes after a laparoscopic hysterectomy (LH) in Dutch hospitals and to assess the nurses’ opinion on this topic. This was particularly relevant as no consensus exists on the best moment to remove a urinary catheter after an LH. All 89 Dutch hospitals were successfully contacted and provided information on their catheterisation regime after LH: 69 (77.5%) hospitals reported removing the catheter the next morning after the LH, while nine hospitals (10.1%) removed it directly at the end of the procedure. The other 11 hospitals had different policies (four hours, up to two days). Additionally, all nurses working in the gynaecology departments of the hospitals affiliated to Leiden University were asked to fill in a self-developed questionnaire. Of the 111 nurses who completed the questionnaire (response rate 81%), 90% was convinced that a direct removal was feasible and 78% would recommend it to a family member or friend.Impact StatementWhat is already known on this subject? Although an indwelling catheter is routinely placed during a hysterectomy, it is unclear what the best moment is to remove it after an LH specifically. To fully benefit from the advantages associated with this minimally invasive approach, postoperative catheter management, should be, amongst others, optimal and LH-specific. A few studies have demonstrated that the direct removal of urinary catheter after an uncomplicated LH is feasible, but the evidence is limited.What the results of this study add? While waiting for the results of the randomised trials, this present study provides insight into the nationwide catheterisation management after an LH. Despite the lack of consensus on the topic, catheterisation management was quite uniform in the Netherlands: most Dutch hospitals removed the urinary catheter one day after an LH. Yet, this was not in line with the opinion of the surveyed nurses, as the majority would recommend a direct removal. This is interesting as nurses are closely involved in the patients’ postoperative care.What are the implications of these findings for clinical practice and/or further research? Although randomised trials are necessary to determine an optimal catheterisation management, the findings of this present study are valuable if a new urinary catheter regime has to be implemented.@en

Background: Pelvic endometriosis is often mentioned as one of the variables influencing surgical outcomes of laparoscopic hysterectomy (LH). However, its additional surgical risks have not been well established. The aim of this study was to analyze to what extent concomitant endometriosis influences surgical outcomes of LH and to determine if it should be considered as case-mix variable. Results: A total of 2655 LH’s were analyzed, of which 397 (15.0%) with concomitant endometriosis. For blood loss and operative time, no measurable association was found for stages I (n = 106) and II (n = 103) endometriosis compared to LH without endometriosis. LH with stages III (n = 93) and IV (n = 95) endometriosis were associated with more intra-operative blood loss (p = <.001) and a prolonged operative time (p = <.001) compared to LH without endometriosis. No significant association was found between endometriosis (all stages) and complications (p =.62). Conclusions: The findings of our study have provided numeric support for the influence of concomitant endometriosis on surgical outcomes of LH, without bowel or bladder dissection. Only stages III and IV were associated with a longer operative time and more blood loss and should thus be considered as case-mix variables in future quality measurement tools.@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

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

Background: Since the introduction of minimally invasive surgery (MIS), concerns for patient safety are more often brought to the attention. Knowledge about and awareness of patient safety risk factors are crucial in order to improve and enhance the surgical team, the environment, and finally surgical performance. The aim of this study was to identify and quantify patient safety risk factors in laparoscopic hysterectomy and to determine their influence on surgical outcomes. Methods: A prospective multicenter study was conducted from April 2014 to January 2016, participating gynecologists registered their performed laparoscopic hysterectomies (LHs). If deemed necessary, gynecologists could fill out a checklist with validated patient safety risk factors. Association between procedures with and without an occurred risk factor(s) and the surgical outcomes (blood loss, operative time, and complications) were assessed, using multivariate logistic regression and generalized estimation equations. Results: Eighty-five gynecologists participated in the study, registering a total of 2237 LHs. For 627(28 %) procedures, the checklist was entered (in total 920 items). The most reported risk factors were related to the surgeon (19.6 %), the surgical team (14.4 %), technology (16.6 %), and the patient (26.8 %). The procedures where a risk factor was registered had significantly less favorable outcomes, higher complication rate (10.5 vs. 4.8 % (p = 0.002), longer operative time [114 vs. 95 min (p < 0.001)], and more blood loss [110 vs. 168 mL (p = 0.047)], which was mainly due to the technological and patient-related risk factors. Conclusion: Technological incidents are the most important and clinically relevant risk factors affecting surgical outcomes of LH. Future improvements of MIS need to focus on this. As awareness of safety risk factors in MIS is important, embedding of a safety risk factor checklist in registration systems will help surgeons to evaluate and improve their individual performance. This will inherently improve the surgical outcomes and thus patient safety.

@en

Purpose: Since the introduction of minimally invasive gynecologic surgery, the percentage of advanced laparoscopic procedures has greatly increased worldwide. It seems therefore, timely to standardize laparoscopic gynecologic care according to the principles of evidence-based medicine. With this goal in mind—the Dutch Society of Gynecological Endoscopic Surgery initiated in The Netherlands the development of a national guideline for laparoscopic hysterectomy (LH). This present article provides a summary of the main recommendations of the guideline. Methods: This guideline was developed following the Dutch guideline of medical specialists and in accordance with the AGREE II tool. Clinically important issues were firstly defined and translated into research questions. A literature search per topic was then conducted to identify relevant articles. The quality of the evidence of these articles was rated following the GRADE systematic. An expert panel consisting of 18 selected gynecologists was consulted to formulate best practice recommendations for each topic. Results: Ten topics were considered in this guideline, including amongst others, the different approaches for hysterectomy, advice regarding tissue extraction, pre-operative medical treatment and prevention of ureter injury. This work resulted in the development of a clinical practical guideline of LH with evidence- and expert-based recommendations. The guideline is currently being implemented in The Netherlands. Conclusion: A guideline for LH was developed. It gives an overview of best clinical practice recommendations. It serves to standardize care, provides guidance for daily practice and aims to guarantee the quality of LH at an (inter)national level.

@en