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Background. During the COVID-19 pandemic the question arises if laparoscopy, as an aerosol forming procedure, poses a potential risk for viral transmission of SARS-CoV-2 to healthcare workers. Methods. A literature search was conducted using PubMed, Embase and MEDLINE. Articles reporting information regarding COVID-19 or other relevant viruses and laparoscopy, surgical smoke, aerosols and viral transmission were included. Results. Although aerosols produced during laparoscopy do not originate from the respiratory tract, the main transmission route of SARS-CoV-2, research did show SARS-CoV-2 to be present in other body fluids. The transmission risk via this route is however considered very low. As previous research showed potential viral transmission during laparoscopy for viruses that spread through contaminated body fluids, there might be a potential risk of SARS-CoV-2 transmission during laparoscopy, albeit considered very small. Conclusion. Due to the small risk compared to widely known benefits of laparoscopy, there is no reason to replace laparoscopy by laparotomy due to COVID-19 infection. To avoid the potential small risk of viral transmission, additional safety measures are advised.

Introduction: The implementation of advanced minimally invasive surgical (MIS) techniques has broadened. An extensive body of literature shows that high hospital and surgeon volumes lead to better patient outcomes. However, no information is available regarding volume trends in the post-implementation phase of MIS. This study investigated these trends and poses suggestions to adjust these developments. This knowledge can provide guidance to optimize patient safe performance of new surgical techniques., Material and Methods: A national retrospective cohort study in the Netherlands. The number of advanced laparoscopic (level 3 and 4) and robotic procedures and the number of gynecologists performing them were collected through a web-based questionnaire to determine hospital and gynecological surgeon volume. These volumes were compared with our previously collected data from 2012., Results: The response rate was 85%. Hospitals produced larger volumes for advanced laparoscopic and robotic procedures. However, still 63% of the hospitals perform low-volume level 4 laparoscopic procedures. Additionally, gynecological surgeon volumes appeared to decrease for level 3 procedures, as the group of gynecologists performing fewer than 20 procedures expanded (64% vs. 44% in 2012), with 15% of the gynecologists performing fewer than ten procedures. Despite an increase in surgeon volumes for level 4 laparoscopy and robotic surgery, volumes continued to be low, as still 49% of gynecologists performed fewer than 10 level 4 procedures per year and 41% performed fewer than 20 robotic procedures per year., Conclusions: The broad implementation of advanced MIS procedures resulted in an increasing number of these procedures with increasing hospital volumes. However, as a side-effect, a disproportionate rise in number of gynecologists performing these procedures was observed. Therefore, surgeon volumes remain low and even decreased for some procedures. Centralization of complex procedures and training of specialized MIS gynecologists could improve surgeon volumes and therefore consequently enhance patient safety., (© 2021 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Objectives: To provide a systematic overview of the literature assessing the value of haptic and force feedback in current simulators teaching laparoscopic surgical skills., Data Sources: The databases of Pubmed, Cochrane, Embase, Web of Science, and Google Scholar were searched to retrieve relevant studies published until January 31st, 2017. The search included laparoscopic surgery, simulation, and haptic or force feedback and all relevant synonyms., Methods: Duplicates were removed, and titles and abstracts screened. The remaining articles were subsequently screened full text and included in this review if they followed the inclusion criteria. A total of 2 types of feedback have been analyzed and will be discussed separately: haptic- and force feedback., Results: A total of 4023 articles were found, of which 87 could be used in this review. A descriptive analysis of the data is provided. Results of the added value of haptic interface devices in virtual reality are variable. Haptic feedback is most important for more complex tasks. The interface devices do not require the highest level of fidelity. Haptic feedback leads to a shorter learning curve with a steadier upward trend. Concerning force feedback, force parameters are measured through force sensing systems in the instrument and/or the environment. These parameters, especially in combination with motion parameters, provide box trainers with an objective evaluation of laparoscopic skills. Feedback of force-use both real time and postpractice has been shown to improve training., Conclusions: Haptic feedback is added to virtual reality simulators to increase the fidelity and thereby improve training effect. Variable results have been found from adding haptic feedback. It is most important for more complex tasks, but results in only minor improvements for novice surgeons. Force parameters and force feedback in box trainers have been shown to improve training results., (Copyright © 2018 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

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 Statement What 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.

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.

Background: During the implementation of new interventions (i.e., surgical devices and technologies) in the operating room, surgical safety might be compromised. Current safety measures are insufficient in detecting safety hazards during this process. The aim of the study was to observe whether surgical teams are capable of measuring surgical safety, especially with regard to the introduction of new interventions., Methods: A Surgical Safety Questionnaire was developed that had to be filled out directly postoperative by three surgical team members. A potential safety concern was defined as at least one answer between (strongly) disagree and indifferent. The validity of the questionnaire was assessed by comparison with the results from video analysis. Two different observers annotated the presence and effect of surgical flow disturbances during 40 laparoscopic hysterectomies performed between November 2010 and April 2012., Results: The surgeon reported a potential safety concern in 16% (85/520 questions). With respect to the scrub nurse and anesthesiologist, this was both 9% (46/520). With respect to the preparation, functioning, and ease of use of the devices in 37.5-47.5% (15-19/40 procedures) a potential safety concern was reported by one or more team members. During procedures after which a potential safety concern was reported, surgical flow disturbances lasted a higher percentage of the procedure duration [9.3 ± 6.2 vs. 2.9 ± 3.7% (mean ± SD), p < .001]. After procedures during which a new instrument or device was used, more potential safety concerns were reported (51.2 vs. 23.1%, p < .001)., Conclusions: Potential safety concerns were especially reported during procedures in which a relatively high percentage of the duration consisted of surgical flow disturbances and during procedures in which a new instrument or device was used. The Surgical Safety Questionnaire can act as a validated tool to evaluate and maintain surgical safety during minimally invasive procedures, especially during the introduction of a new intervention.

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 = 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.

Background: The success of newly introduced surgical techniques is generally primarily assessed by surgical outcome measures. However, data on medical liability should concomitantly be used to evaluate provided care as they give a unique insight into substandard care from patient's point of view. The aim of this study was to analyze the number and type of medical claims after laparoscopic gynecologic procedures since the introduction of advanced laparoscopy two decades ago. Secondly, our objective was to identify trends and/or risk factors associated with these claims., Methods: To identify the claims, we searched the databases of the two largest medical liability mutual insurance companies in The Netherlands (MediRisk and Centramed), covering together 96% of the Dutch hospitals. All claims related to laparoscopic gynecologic surgery and filed between 1993 and 2015 were included., Results: A total of 133 claims met our inclusion criteria, of which 54 were accepted claims (41%) and 79 rejected (59%). The number of claims remained relatively constant over time. The majority of claims were filed for visceral and/or vascular injuries (82%), specifically to the bowel (40%) and ureters (20%). More than one-third of the injuries were entry related (38%) and 77% of the claims were filed after non-advanced procedures. A delay in diagnosing injuries was the primary reason for financial compensation (33%). The median sum paid to patients was €12,000 (500-848,689). In 90 claims, an attorney was defending the patient (83% for the accepted claims; 57% for the rejected claims)., Conclusion: The number of claims remained relatively constant during the study period. Most claims were provoked by bowel and ureter injuries. Delay in recognizing injuries was the most encountered reason for granting financial compensation. Entering the abdominal cavity during laparoscopy continues to be a potential dangerous step. As a result, gynecologists are recommended to thoroughly counsel patients undergoing any laparoscopic procedure, even regarding the risk of entry-related injuries.

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.

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.

Purpose: To assess the safety and effectiveness of LESS compared to conventional hysterectomy., Methods: The systematic review and meta-analysis was performed according to the MOOSE guideline, and quality of evidence was assessed using GRADE. Different databases were searched up to 4th of August 2016. Randomized controlled trials and cohort studies comparing LESS to the conventional laparoscopic hysterectomy were considered for inclusion., Results: Of the 668 unique articles, 23 were found relevant. We investigated safety by analyzing the complication rate and found no significant differences between both groups [OR 0.94 (0.61, 1.44), I 2  = 19%]. We assessed effectiveness by analyzing conversion risk, postoperative pain, and patient satisfaction. For conversion rates to laparotomy, no differences were identified [OR 1.60 (0.40, 6.38), I 2  = 45%]. In 3.5% of the cases in the LESS group, an additional port was needed during LESS. For postoperative pain scores and patient satisfaction, some of the included studies reported favorable results for LESS, but the clinical relevance was non-significant. Concerning secondary outcomes, only a difference in operative time was found in favor of the conventional group [MD 11.3 min (5.45-17.17), I 2  = 89%]. The quality of evidence for our primary outcomes was low or very low due to the study designs and lack of power for the specified outcomes. Therefore, caution is urged when interpreting the results., Conclusion: The single-port technique for benign hysterectomy is feasible, safe, and equally effective compared to the conventional technique. No clinically relevant advantages were identified, and as no data on cost effectiveness are available, there are currently not enough valid arguments to broadly implement LESS for hysterectomy.

Objective: Serious games are new in the field of laparoscopic surgical training. We evaluate the residents׳ opinion of a new laparoscopic simulator for the Nintendo Wii-U platform., Design: Prospective questionnaire study. Participants received a standardized introduction and completed level 3 and 4 of the game "Underground." They filled out a questionnaire concerning demographics and their opinion on realism, usefulness, suitability, haptic feedback, and home training-use of the game., Setting: Two tertiary teaching hospitals., Participants: Obstetrics and gynaecology residents postgraduate year 1 to 6 (n = 59) from several European countries., Results: Subjects (n = 59) were divided into 2 groups based on laparoscopic experience: Group A (n = 38) and Group B (n = 21). The realism of different aspects of the game received mean scores around 3 on a 5-point Likert scale. The hand-eye coordination was regarded most useful for training with a mean of 3.92 (standard deviation 0.93) and the game was considered most suitable for residents in the first part of their postgraduate training with a mean of 3.73 (standard deviation 0.97). Both groups differed especially concerning their opinion of the usefulness of the game as a training tool., Conclusions: Most residents liked the new serious game for the Nintendo Wii-U. The usefulness and suitability as a laparoscopic training tool were rated at an acceptable to high level. However, the game does require improvements such as inclusion of a good scoring system before it can be integrated in resident training curricula., (Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

Hysterectomies performed laparoscopically have greatly increased within the last few decades and even exceed the number of vaginal hysterectomies (VHs). This systematic review, conducted according to the Meta-analysis of Observational Studies in Epidemiology guidelines, compares surgical outcomes of total laparoscopic hysterectomy (TLH) and VH to evaluate which approach offers the most benefits. A literature search was performed in PubMed, Embase, and Web of Science for all relevant publications from January 2000 to February 2016. All randomized controlled trials and cohort studies for benign indication or low-grade malignancy comparing TLH with VH were considered for inclusion. From the literature search, 24 articles were found to be relevant and included in this review. The results of our meta-analysis showed no difference between the 2 groups for overall complications (OR 1.24 [.68, 2.28] for major complications; OR .83 [.53, 1.28] for minor complications), risk of ureter and bladder injuries (OR .81 [.34, 1.92]), intraoperative blood loss (mean difference [MD] -30 mL [-67.34, 7.60]), and length of hospital stay (-.61 days [-1.23, -.01]). VH was associated with a shorter operative time (MD 42 minute [29.34, 55.91]) and a lower rate of vaginal cuff dehiscence (OR 6.28 [2.38, 16.57]) and conversion to laparotomy (OR 3.89 [2.18, 6.95]). Although not significant, the costs of procedure were lower for VH (MD 3889.9 dollars [2120.3, 89 000]). Patients in the TLH group had lower postoperative visual analog scale scores (MD -1.08, [-1.74, -.42]) and required less analgesia during a shorter period of time (MD -.64 days, [-1.06, -.22]). Defining the best surgical approach is a dynamic process that requires frequent re-evaluation as techniques improve. Although TLH and VH result in similar outcomes, our meta-analysis showed that when both procedures are feasible, VH is currently still associated with greater benefits, such as shorter operative time, lower rate of vaginal dehiscence and conversion to laparotomy, and lower costs. Many factors influence the choice for surgical approach to hysterectomy, and shared decision-making is recommended., (Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare hospital versus individual surgeon's perioperative outcomes for laparoscopic hysterectomy (LH), and to assess the relationship between surgeon experience and perioperative outcomes., Methods: A retrospective analysis of all prospective collected LHs performed from 2003 to 2010 at one medical center was performed. Perioperative outcomes (operative time, blood loss, complication rate) were assessed on both a hospital level and surgeon level using Cumulative Observed minus Expected performance graphs., Results: A total of 1618 LHs were performed, 16 % total laparoscopic hysterectomies and 84 % laparoscopic supracervical hysterectomies. Overall outcomes included mean (SD±) blood loss 108.9 ± 69.2 mL, mean operative time 95.4 ± 39.7 min and a complication occurred in 76 (4.7 %) of cases. Suboptimal perioperative outcomes of an individual surgeon were not always detected on a hospital level. However, collective suboptimal outcomes were faster detected on a hospital level compared to individual surgeon's level. Evidence of a learning curve is seen; for the first 100 procedures, a decrease in operative time is observed as individual surgeon experience increases. Similarly, the risk of conversion decreases up to the first 50 procedures., Conclusion: An individual outlier (i.e., surgeon with consistently suboptimal performance) will not always be detected when monitoring outcome measures only on a hospital level. However, monitoring outcome measures on a hospital level will detect suboptimal performance earlier compared to monitoring only on an individual surgeon's level. To detect performance outliers timely, insight into an individual surgeon's outcome and skills is recommended. Furthermore, an experienced surgeon is no guarantee for acceptable surgical outcomes., Competing Interests: Compliance with ethical standards Funding This study was not funded. Conflict of interest All authors declare that they have no conflict of interest. Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent Because the requested patient data were completely anonymous, not identifiable and retrospective collected between 2003-2010, this study was exempt for informed consent from all participants.

Background: The current health care system has an urgent need for tools to measure quality. A wide range of quality indicators have been developed in an attempt to differentiate between high-quality and low-quality health care processes. However, one of the main issues of currently used indicators is the lack of case-mix correction and improvement possibilities. Case-mix is defined as specific (patient) characteristics that are known to potentially affect (surgical) outcome. If these characteristics are not taken into consideration, comparisons of outcome among health care providers may not be valid., Objective: The objective of the study was to develop and test a quality assessment tool for laparoscopic hysterectomy, which can serve as a new outcome quality indicator., Study Design: This is a prospective, international, multicenter implementation study. A web-based application was developed with 3 main goals: (1) to measure the surgeon's performance using 3 primary outcomes (blood loss, operative time, and complications); (2) to provide immediate individual feedback using cumulative observed-minus-expected graphs; and (3) to detect consistently suboptimal performance after correcting for case-mix characteristics. All gynecologists who perform laparoscopic hysterectomies were requested to register their procedures in the application. A patient safety risk factor checklist was used by the surgeon for reflection. Thereafter a prospective implementation study was performed, and the application was tested using a survey that included the System Usability Scale., Results: A total of 2066 laparoscopic hysterectomies were registered by 81 gynecologists. Mean operative time was 100 ± 39 minutes, blood loss 127 ± 163 mL, and the complication rate 6.1%. The overall survey response rate was 75%, and the mean System Usability Scale was 76.5 ± 13.6, which indicates that the application was good to excellent. The majority of surgeons reported that the application made them more aware of their performance, the outcomes, and patient safety, and they noted that the application provided motivation for improving future performance., Conclusion: We report the development and test of a real-time, dynamic, quality assessment tool for measuring individual surgical outcome for laparoscopic hysterectomy. Importantly, this tool provides opportunities for improving surgical performance. Our study provides a foundation for helping clinicians develop evidence-based quality indicators for other surgical procedures., (Copyright © 2016 Elsevier Inc. All rights reserved.)

The assessment of surgical quality is complex, and an adequate case-mix correction is missing in currently applied quality indicators. The purpose of this study is to give an overview of all studies mentioning statistically significant associations between patient characteristics and surgical outcomes for laparoscopic hysterectomy (LH). Additionally, we identified a set of potential case-mix characteristics for LH. This systematic review was conducted according to the Meta-Analysis of Observational Studies in Epidemiology guidelines. We searched PubMed and EMBASE from January 1, 2000 to August 1, 2015. All articles describing statistically significant associations between patient characteristics and adverse outcomes of LH for benign indications were included. Primary outcomes were blood loss, operative time, conversion, and complications. The methodologic quality of the included studies was assessed using the Newcastle-Ottawa Quality Assessment Scale. The included articles were summed per predictor and surgical outcome. Three sets of case-mix characteristics were determined, stratified by different levels of evidence. Eighty-five of 1549 identified studies were considered eligible. Uterine weight and body mass index (BMI) were the most mentioned predictors (described, respectively, 83 and 45 times) in high quality studies. For longer operative time and higher blood loss, uterine weight ≥ 250 to 300 g and ≥500 g and BMI ≥ 30 kg/m(2) dominated as predictors. Previous operations, adhesions, and higher age were also considered as predictors for longer operative time. For complications and conversions, the patient characteristics varied widely, and uterine weight, BMI, previous operations, adhesions, and age predominated. Studies of high methodologic quality indicated uterine weight and BMI as relevant case-mix characteristics for all surgical outcomes. For future development of quality indicators of LH and to compare surgical outcomes adequately, a case-mix correction is suggested for at least uterine weight and BMI. A potential case-mix correction for adhesions and previous operations can be considered. For both surgeons and patients it is valuable to be aware of potential factors predicting adverse outcomes and to anticipate this. Finally, to benchmark clinical outcomes at an international level, it is of the utmost importance to introduce uniform outcome definitions., (Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.)

Objectives: To report the surgical outcomes of laparoscopic myomectomy (LM) and abdominal myomectomy (AM) at a high-volume tertiary care hospital, to evaluate the risk of conversion during LM, and to analyze the associated risk factors., Design: Retrospective cohort study (Canadian Task Force classification II)., Patients: All patients who underwent LM and AM in a tertiary academic center in Boston, Massachusetts between 2009 and 2012., Intervention: Medical records were reviewed for baseline characteristics and perioperative outcomes. Robot-assisted laparoscopy was considered a subtype of LM., Results: A total of 966 patients underwent myomectomy during the study period, including 731 LM cases (75.67%) and 235 AM cases (24.33%). Compared with patients undergoing LM, those undergoing AM had more myomas removed and heavier specimens (mean number of myomas, 12.60 vs 3.54, p ≤ .001; mean weight, 592.75 g vs 263.4 g, p ≤ .001). Conversion was necessary in 8 LM cases (1.09%). All conversions were reactive in nature and were associated with greater blood loss (mean, 1381.25 vs 167.95 mL; p ≤ .001) and longer hospital stay (mean, 3.13 vs 0.55 days; p ≤ .001) compared with cases without conversion. Factors associated with conversion included both the number and the weight of myomas removed (mean number, 9.75 vs 3.48, p = .003; mean weight, 667.9 vs 259.25 g, p = .015), especially with myomas weighing >500 g (odds ratio = 8.551; p = .005)., Conclusion: The risk of conversion for LM was low (1.09%) in this cohort, and was associated both with the number and the weight of myomas removed. LM is a feasible approach for surgical management of myomas in the majority of cases; however, when myomas are expected to weigh >500 g, it may be prudent to consider referring those cases to specialized centers with highly experienced teams., (Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: To assess features of power morcellators (blade diameter, circular vs oscillating cutting, blade rotation speed, experience level) regarding their effect on the amount of tissue spill. In addition, the amount of tissue spill after the initial two-thirds and final one-third of the morcellated specimen was evaluated., Design: In vitro study (Canadian Task Force classification II-2)., Setting: Laparoscopic skills lab of an academic hospital., Patients: Not applicable., Intervention: Power morcellation of beef tongue specimens., Measurements and Main Results: Twenty-four trials were performed. Morcellation was performed in 2 phases (phase 1: initial two-thirds of the total tissue; phase 2: last one-third of the tissue). With larger blade diameter a decline was observed in both the weight of the spilled particles (phase 1) and the number of spilled particles (phases 1 and 2 and both combined) (weight phase 1: 6.5 g vs 6.3 g vs 2.2 g for 12.5 mm vs 15 mm vs 20 mm, respectively, p = .04; number particles: phase 1, 10.2 vs 7.2 vs 2.7, p = .01; phase 2, 22.9 vs 19.0 vs 8.9, p = .02; total, 34.7 vs 26.2 vs 11.6, p = .01). Also, spinning of the tissue mass due to torque applied by the rotating blade occurred later when blade size increased, and the size of the spilled particles was larger (weight of morcellated tissue at onset of torque: 136 g vs 198 g vs 222 g, p = .07; size: .6 g vs .9 g vs .8 g, p = .1). In the oscillation mode there was less total spill (6.8 g/100 g vs 21.3 g/100 g, p = .01, for oscillation and circular cutting, respectively)., Conclusion: The present study demonstrates that less spill is created by power morcellators with an oscillating blade and/or a large diameter (≥20 mm). Furthermore, when using a large-diameter blade the spilled particles are larger, and less morcellation repetitions are needed. By combining these features with currently introduced contained morcellation, the safety of the morcellation process with respect to tissue spill can be further improved., (Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.)

Background: Laparoscopic surgery has led to great clinical improvements in many fields of surgery; however, it requires the use of trocars, which may lead to complications as well as postoperative pain. The complications include intra-abdominal vascular and visceral injury, trocar site bleeding, herniation and infection. Many of these are extremely rare, such as vascular and visceral injury, but may be life-threatening; therefore, it is important to determine how these types of complications may be prevented. It is hypothesised that trocar-related complications and pain may be attributable to certain types of trocars. This systematic review was designed to improve patient safety by determining which, if any, specific trocar types are less likely to result in complications and postoperative pain., Objectives: To analyse the rates of trocar-related complications and postoperative pain for different trocar types used in people undergoing laparoscopy, regardless of the condition., Search Methods: Two experienced librarians conducted a comprehensive search for randomised controlled trials (RCTs) in the Menstrual Disorders and Subfertility Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, CINAHL, CDSR and DARE (up to 26 May 2015). We checked trial registers and reference lists from trial and review articles, and approached content experts., Selection Criteria: RCTs that compared rates of trocar-related complications and postoperative pain for different trocar types used in people undergoing laparoscopy. The primary outcomes were major trocar-related complications, such as mortality, conversion due to any trocar-related adverse event, visceral injury, vascular injury and other injuries that required intensive care unit (ICU) management or a subsequent surgical, endoscopic or radiological intervention. Secondary outcomes were minor trocar-related complications and postoperative pain. We excluded trials that studied non-conventional laparoscopic incisions., Data Collection and Analysis: Two review authors independently conducted the study selection, risk of bias assessment and data extraction. We used GRADE to assess the overall quality of the evidence. We performed sensitivity analyses and investigation of heterogeneity, where possible., Main Results: We included seven RCTs (654 participants). One RCT studied four different trocar types, while the remaining six RCTs studied two different types. The following trocar types were examined: radially expanding versus cutting (six studies; 604 participants), conical blunt-tipped versus cutting (two studies; 72 participants), radially expanding versus conical blunt-tipped (one study; 28 participants) and single-bladed versus pyramidal-bladed (one study; 28 participants). The evidence was very low quality: limitations were insufficient power, very serious imprecision and incomplete outcome data. Primary outcomesFour of the included studies reported on visceral and vascular injury (571 participants), which are two of our primary outcomes. These RCTs examined 473 participants where radially expanding versus cutting trocars were used. We found no evidence of a difference in the incidence of visceral (Peto odds ratio (OR) 0.95, 95% confidence interval (CI) 0.06 to 15.32) and vascular injury (Peto OR 0.14, 95% CI 0.0 to 7.16), both very low quality evidence. However, the incidence of these types of injuries were extremely low (i.e. two cases of visceral and one case of vascular injury for all of the included studies). There were no cases of either visceral or vascular injury for any of the other trocar type comparisons. No studies reported on any other primary outcomes, such as mortality, conversion to laparotomy, intensive care admission or any re-intervention. Secondary outcomesFor trocar site bleeding, the use of radially expanding trocars was associated with a lower risk of trocar site bleeding compared to cutting trocars (Peto OR 0.28, 95% CI 0.14 to 0.54, five studies, 553 participants, very low quality evidence). This suggests that if the risk of trocar site bleeding with the use of cutting trocars is assumed to be 11.5%, the risk with the use of radially expanding trocars would be 3.5%. There was insufficient evidence to reach a conclusion regarding other trocar types, their related complications and postoperative pain, as no studies reported data suitable for analysis., Authors' Conclusions: Data were lacking on the incidence of major trocar-related complications, such as visceral or vascular injury, when comparing different trocar types with one another. However, caution is urged when interpreting these results because the incidence of serious complications following the use of a trocar was extremely low. There was very low quality evidence for minor trocar-related complications suggesting that the use of radially expanding trocars compared to cutting trocars leads to reduced incidence of trocar site bleeding. These secondary outcomes are viewed to be of less clinical importance.Large, well-conducted observational studies are necessary to answer the questions addressed in this review because serious complications, such as visceral or vascular injury, are extremely rare. However, for other outcomes, such as trocar site herniation, bleeding or infection, large observational studies may be needed as well. In order to answer these questions, it is advisable to establish an international network for recording these types of complications following laparoscopic surgery.

Purpose: Some studies suggest that also regarding the patient with a body mass index (BMI) ≥35 kg/m(2) the minimally invasive approach to hysterectomy is superior. However, current practice and research on the preference of gynaecologists still show that the rate of abdominal hysterectomy (AH) increases as the BMI increases. A systematic review with cumulative analysis of comparative studies was performed to evaluate the outcomes of AH, laparoscopic hysterectomy (LH) and vaginal hysterectomy (VH) in very obese and morbidly obese patients (BMI ≥35 kg/m(2))., Methods: PubMed and EMBASE were searched for records on AH, LH and VH for benign indications or (early stage) malignancy through October 2014. Included studies were graded on level of evidence. Studies with a comparative design were pooled in a cumulative analysis., Results: Two randomized controlled trials, seven prospective studies and 14 retrospective studies were included (2232 patients; 1058 AHs, 959 LHs, and 215 VHs). The cumulative analysis identified that, compared to LH, AH was associated with more wound dehiscence [risk ratio (RR) 2.58, 95 % confidence interval (CI) 1.71-3.90; P = 0.000], more wound infection (RR 4.36, 95 % CI 2.79-6.80; P = 0.000), and longer hospital admission (mean difference 2.9 days, 95 % CI 1.96-3.74; P = 0.000). The pooled conversion rate was 10.6 %. Compared to AH, VH was associated with similar advantages as LH., Conclusions: Compared to AH, both LH and VH are associated with fewer postoperative complications and shorter length of hospital stay. Therefore, the feasibility of LH and VH should be considered prior the abdominal approach to hysterectomy in very obese and morbidly obese patients.

Objectives: To assess the current state of laparoscopic gynecologic surgery in the Dutch residency program, the level of competence among graduated residents, and whether they still perform these procedures. Furthermore, their current attitudes toward the implementation of minimally invasive surgery into residency training were assessed., Design: An online survey (Canadian Task Force Classification III) regarding the level of competence, performance, training, and interest for gynecologic laparoscopic procedures., Participants/setting: Gynecologists who finished residency training between 2008 and 2013 in the Netherlands., Results: Response rate was 73% (171/235). The scores for all basic and intermediate laparoscopic procedures performed immediately after residency showed the highest competence level (median 5, of scale 1-5). The competence level for advanced laparoscopic procedures was less at 3, indicating that the graduated residents are not able to perform these procedures without supervision. Overall, 56% of the gynecologists no longer perform any level 3 advanced procedures, and 86% do not perform level 4 advanced procedures. Gynecologists who still perform the inquired laparoscopic procedures scored a significantly higher competence level immediately after residency training for most of procedures compared with the gynecologists who do not perform these procedures., Conclusion: Residents are sufficiently trained for basic and intermediate laparoscopic procedures during residency training. However, they are not sufficiently equipped to perform advanced laparoscopic procedures without supervision. We should consider training advanced procedures especially to a selected group of residents because most gynecologists do not perform these procedures after residency. The learning curve for advanced procedures continues to rise after finishing residency for those who keep on performing these procedures, therefore an additional fellowship is recommended for this group., (Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

Study Objectives: To assess the implementation of advanced laparoscopic gynecologic surgical procedures, assess the number of gynecologists performing these procedures, and highlight the distribution of surgical approaches to hysterectomy., Design: Observational multicenter study., Design Classification: Canadian Task Force classification II-2., Setting: All hospitals in The Netherlands., Sample: Minimally invasive surgical procedures performed in all 90 hospitals in the year 2012, and the number of gynecologists performing these procedures. Data were compared with national surveys conducted in 2002 and 2007., Interventions: The number of advanced laparoscopic gynecologic procedures, the number of gynecologists performing these procedures, and the distribution of approaches to hysterectomy were collected through a Web-based questionnaire., Measurements and Main Results: The response rate was 96% (86 of 90 hospitals). A total of 4979 advanced laparoscopic gynecologic procedures were performed in 2012 (mean per hospital, 58; median, 50.5; SD, 44.4), which is a significant increase over 2007 (95% CI, 30.3-46.5; p < .001). The proportion of laparoscopic hysterectomy increased from 3% in 2002 to 10% in 2007 and to 36% in 2012. The proportions of abdominal hysterectomy (68% in 2002, 54% in 2007, and 39% in 2012) and vaginal hysterectomy (29% in 2002, 36% in 2007, and 25% in 2012) decreased significantly. However, approximately 37% of gynecologists (n = 76) and 12% of hospitals (n = 9) performed fewer than 20 advanced laparoscopic procedures (level 3 and level 4) annually., Conclusions: Implementation of advanced laparoscopic gynecologic procedures has accelerated tremendously in the last decade, owing mainly to the increased number of laparoscopic hysterectomies. A significant shift has occurred from abdominal and vaginal hysterectomies toward a laparoscopic approach. The vaginal hysterectomy should be brought back in focus, to prevent the deterioration of skills needed to perform this least invasive approach. Furthermore, the introduction of case volume as quality assessment is sure to have consequences for daily gynecologic surgical practice in The Netherlands., (Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: To assess the basic morcellation process in laparoscopic supracervical hysterectomy (LSH). Proper understanding of this process may help enhance future efficacy of morcellation regarding the prevention of tissue scatter., Design: Time-action analysis was performed based on video imaging of the procedures (Canadian Task Force classification II-2)., Setting: Procedures were performed at Leiden University Medical Centre and St Lucas Andreas Hospital, Amsterdam, the Netherlands., Patients: Women undergoing LSH for benign conditions., Interventions: Power morcellation of uterine tissue., Measurements and Main Results: The morcellation process was divided into 4 stages: tissue manipulation, tissue cutting, tissue depositing, and cleaning. Stages were timed, and perioperative data were gathered. Data were analyzed as a whole and after subdivision into 3 groups according to uterine weight: <350 g, 350 to 750 g, and >750 g. A cutoff point was found at a uterine weight of 350 g, after which an increase in uterine weight did not affect the cleaning stage. The tissue strip cutting time was used as a measure for tissue strip length. With progression of the morcellation process, the tissue strip cutting time decreases. The majority of cutting time is of short duration (i.e., 60% of the cutting lasts 5 seconds or less), and these occur later on in the morcellation process., Conclusion: With the current power morcellators, the amount of tissue spread peaks and is independent of uterine weight after a certain cutoff point (in this study 350 g). There is a relative inefficiency in the rotational mechanism because mostly small tissue strips are created. These small tissue strips occur increasingly later on in the procedure. Because small tissue strips are inherently more prone to scatter by the rotational mechanism of the morcellator, the risk of tissue spread is highest at the end of the morcellation procedure. This means that LSH and laparoscopic hysterectomy procedures may be at higher risk for tissue scatter than total laparoscopic hysterectomy. Finally, engineers should evaluate how to create only large tissue strips or assess alternatives to the rotational mechanism., (Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.)

Hysterectomy is still one of the most frequently performed gynaecological procedures. The use of the laparoscopic approach has increased over recent years and a shift in indication has been observed. However, not every clinic or gynaecologist is able to provide laparoscopic hysterectomy for more challenging patients. Therefore, referral to an expert centre is of the highest importance in order to offer the patient the least invasive approach to hysterectomy. The advantages of the laparoscopic approach have become more evident over recent years. The widespread introduction of minimally invasive surgery means that surgeons are encountering new challenges, such as the rapid introduction of new instruments, the absolute increased incidence of rare complications and the provision of post-operative counselling on recovery. Maintaining knowledge of these matters is essential in order to secure the quality of care.

Background: The success of newly introduced surgical techniques is generally primarily assessed by surgical outcome measures. However, data on medical liability should concomitantly be used to evaluate provided care as they give a unique insight into substandard care from patient's point of view. The aim of this study was to analyze the number and type of medical claims after laparoscopic gynecologic procedures since the introduction of advanced laparoscopy two decades ago. Secondly, our objective was to identify trends and/or risk factors associated with these claims.Methods: To identify the claims, we searched the databases of the two largest medical liability mutual insurance companies in The Netherlands (MediRisk and Centramed), covering together 96% of the Dutch hospitals. All claims related to laparoscopic gynecologic surgery and filed between 1993 and 2015 were included.Results: A total of 133 claims met our inclusion criteria, of which 54 were accepted claims (41%) and 79 rejected (59%). The number of claims remained relatively constant over time. The majority of claims were filed for visceral and/or vascular injuries (82%), specifically to the bowel (40%) and ureters (20%). More than one-third of the injuries were entry related (38%) and 77% of the claims were filed after non-advanced procedures. A delay in diagnosing injuries was the primary reason for financial compensation (33%). The median sum paid to patients was €12,000 (500-848,689). In 90 claims, an attorney was defending the patient (83% for the accepted claims; 57% for the rejected claims).Conclusion: The number of claims remained relatively constant during the study period. Most claims were provoked by bowel and ureter injuries. Delay in recognizing injuries was the most encountered reason for granting financial compensation. Entering the abdominal cavity during laparoscopy continues to be a potential dangerous step. As a result, gynecologists are recommended to thoroughly counsel patients undergoing any laparoscopic procedure, even regarding the risk of entry-related injuries. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Minimally invasive surgery (MIS) is frequently compromised by surgical flow disturbances due to technology- and equipment-related failures. Compared with MIS in a conventional cart-based OR, performing MIS in a dedicated integrated operating room (OR) is supposed to be beneficial to patient safety. The aim of this study was to compare a conventional OR with an integrated OR with regard to the incidence and effect of equipment-related surgical flow disturbances during an advanced laparoscopic gynecological procedure [laparoscopic hysterectomy (LH)].Methods: Using video recording, 40 LHs performed between November 2010 and April 2012 (20 in a conventional cart-based OR and 20 in an integrated OR) were analyzed by two different observers. Outcome measures were the number, duration and effect (on a seven-point ordinal scale) of the surgical flow disturbances (e.g., malfunctioning, intraoperative repositioning, setup device).Results: A total of 103 h and 45 min was observed. The interobserver agreement was high (kappa .85, p < .001). Procedure time was not significantly different (NS) [conventional OR vs. integrated OR, minutes ± standard deviation (SD), mean 161 ± 27 vs. 150 ± 34]. A total of 1651 surgical flow disturbances were observed (mean ± SD per procedure 40.8 ± 19.4 vs. 41.8 ± 15.9, NS). The mean number of surgical flow disturbances per procedure with regard to equipment was 6.3 ± 3.7 versus 8.5 ± 4.0, NS. No clinically relevant differences in the mean effect of these disturbances on the surgical flow between the two OR setups were observed.Conclusions: Performing LH in an integrated OR did not reduce the number of surgical flow disturbances nor the effect of these disturbances. Furthermore, in the integrated OR, repositioning of the monitors was a frequent and time-consuming source of disturbance. In order to maintain the high standard of surgical safety, the entire surgical team has to be aware that by performing surgery in an integrated OR different potential source for disruption arise. [ABSTRACT FROM AUTHOR]