The (cost-) effectiveness Of Surgical excision of Colorectal endometriosis compared to ART treatment trAjectory (TOSCA study) - a study protocol.

Currently, the optimal treatment to increase the chance of pregnancy and live birth in patients with colorectal endometriosis and subfertility is unknown. Evidence suggests that that both surgery and in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) are effective in improving live birth rate (LBR) among these women. However, the available evidence is of low quality, reports highly heterogeneous results, lacks direct comparison between both treatment options and does not assess whether a combination strategy results in a higher LBR compared to IVF/ICSI-only treatment. Additionally, the optimal timing of surgery within the treatment trajectory remains unclear. The primary objective of the TOSCA study is to assess the effectiveness of surgical treatment (potentially combined with IVF/ICSI) compared to IVF/ICSI-only treatment to increase the chance of an ongoing pregnancy resulting in a live birth in patients with colorectal endometriosis and subfertility, measured by cumulative LBR. Secondary objectives are to assess and compare quality of life and cost-effectiveness in both groups. Patients will be followed for 40 months after inclusion or until live birth. The TOSCA study is expected to be completed in 6 years.

Histological analysis of (antral) follicle density in ovarian cortex tissue attached to stripped endometriomas.

PURPOSE: When resecting endometriomas with the stripping technique, in the majority of cases, a thin line of adjacent ovarian cortex is attached to the endometrioma. In this study, we performed histological analysis to determine (antral) follicle density in the ovarian cortex tissue attached to stripped endometriomas and assessed patient- and surgical characteristics that could affect this. METHODS: Histological slides of previously removed endometriomas were assessed. Follicles in the attached ovarian tissue were classified according to maturation, and follicular density was determined. Immunofluorescent staining of antral follicles in a subset of endometriomas was also performed. RESULTS: In 90 out of 96 included endometriomas (93.7%), ovarian tissue attached to the cyst wall was observed. One thousand nine hundred forty-four follicles at different maturation stages were identified (3 follicles/mm3). Follicle density was negatively associated with age (p < 0.001). Antral follicles (< 7-mm diameter) were present in the ovarian tissue attached to 35 endometriomas (36.5%) derived from younger patients compared to endometriomas where none were detected (30 versus 35 years, p = 0.003). Antral follicle density was 1 follicle/mm3. Based on immunofluorescence, healthy antral follicles were identified in two out of four examined endometriomas. CONCLUSIONS: Ovarian tissue attached to stripped endometriomas holds potential as a non-invasive source for antral follicles. In theory, application of IVM could be an interesting alternative FP option in young patients with endometriomas who undergo cystectomy in order to transform the surgical collateral damage to a potential oocyte source. Our results encourage future research with fresh tissue to further assess the quality and potential of these follicles. TRIAL REGISTRATION: Clinical Trials.gov Identifier: B21.055 (METC LDD), date of registration 12-08-2021, retrospectively registered.

Evaluation of the effect of previous endometriosis surgery on clinical and surgical outcomes of subsequent endometriosis surgery.

PURPOSE: Patients often undergo repeat surgery for endometriosis, due to recurrent or residual disease. Previous surgery is often considered a risk factor for worse surgical outcome. However, data are scarce concerning the influence of subsequent endometriosis surgery. METHODS: A retrospective study in a centre of expertise for endometriosis was conducted. All endometriosis subtypes and intra-operative steps were included. Detailed information regarding surgical history of patients was collected. Surgical time, intra-operative steps and major post-operative complications were obtained as outcome measures. RESULTS: 595 patients were included, of which 45.9% had previous endometriosis surgery. 7.9% had major post-operative complications and 4.4% intra-operative complications. The patient journey showed a median of 3 years between previous endometriosis surgeries. Each previous therapeutic laparotomic surgery resulted on average in 13 additional minutes (p = 0.013) of surgical time. Additionally, it resulted in more frequent performance of adhesiolysis (OR 2.96, p < 0.001) and in a higher risk for intra-operative complications (OR 1.81, p = 0.045), however no higher risk for major post-operative complications (OR 1.29, p = 0.418). Previous therapeutic laparoscopic endometriosis surgery, laparotomic and laparoscopic non-endometriosis surgery showed no association with surgical outcomes. Regardless of previous surgery, disc and segmental bowel resection showed a higher risk for major post-operative complications (OR 3.64, p = 0.017 respectively OR 3.50, p < 0.001). CONCLUSION: Previous therapeutic laparotomic endometriosis surgery shows an association with longer surgical time, the need to perform adhesiolysis, and more intra-operative complications in the subsequent surgery for endometriosis. However, in a centre of expertise with experienced surgeons, no increased risk of major post-operative complications was observed.

Biomarker identification for endometriosis as a target for real-time intraoperative fluorescent imaging: A new approach using transcriptomic analysis to broaden the search for potential biomarkers.

Intra-operative fluorescent imaging of endometriosis could help to optimize surgical treatment. Potential biomarkers to use as target for endometriosis-binding fluorescent probes were identified using a new five-phase transcriptomics-based approach to broaden the search for biomarkers. Using publicly available datasets, a differentially expressed gene (DEG) analysis was performed for endometriosis versus surgically relevant surrounding tissue (peritoneum, bladder, sigmoid, rectum, transverse colon, small intestine, vagina, and fallopian tubes) for which data was available. The remaining relevant surrounding tissues were analyzed for low expression levels. DEGs with a predicted membranous or extracellular location and with low expression levels in surrounding tissue were identified as candidate targets. Modified Target Selection Criteria were used to rank candidate targets based on the highest potential for use in fluorescent imaging. 29 potential biomarkers were ranked, resulting in Folate receptor 1 as the most potential biomarker. This is a first step towards finding a fluorescent tracer for intra-operative visualization of endometriosis. Additionally, this approach, using transcriptomics analysis to identifying candidate targets for a specific type of tissue for use in fluorescence-guided surgery could be translated to other surgical fields. TWEETABLE ABSTRACT: A new approach using transcriptomics analysis is shown to identify candidate targets for intra-operative fluorescent imaging for endometriosis, resulting in 29 potential candidates.

Bowel preparation in MRI for detection of endometriosis: Comparison of the effect of an enema, no additional medication and intravenous butylscopolamine on image quality.

PURPOSE: To compare the effect of three different patient preparation strategies for reducing bowel motion on image quality in pelvic MRI. METHODS: Retrospective study in which 95 consecutive patients undergoing pelvic MRI were subdivided based on preparation type for reduction of bowel motion: group 1 (N = 31) fasted 4 h and applied an enema (Bisacodyl 10 mg); group 2 (N = 32) received no medication; group 3 (N = 32) received intravenous butylscopolamine (Buscopan® 50 mg). Image quality was reviewed by visual assessment of delineation (3-point-scale) of pelvic structures: uterus, adnexa, bladder, rectum, sigmoid, uterosacral ligaments, round ligaments and small bowel. As secondary endpoint the presence of rectal wall edema was evaluated. Interobserver agreement was calculated, as well as relative diagnostic odds ratios (RDOR) for the protocols to provide an outcome in the best delineation category. RESULTS: Interobserver agreement proportions varied from 0.48 to 1.00. The rectum and sigmoid colon respectively have a 5.4 and 2.6 RDOR when butylscopolamine is applied compared to Bisacodyl (P = 0.051; P = 0.008), and a 4.2 and 5.7 times higher RDOR with Bisacodyl preparation compared to no medical preparation (P = 0.006; P < 0.01). Small bowel delineation was significantly better with butylscopolamine compared to Bisacodyl (P = 0.007). There was no significant difference in delineation of the other structures between protocols. There is a significant higher chance of observing rectal wall edema with Bisacodyl compared to the other protocols (both P < 0.001). CONCLUSIONS: Butylscopolamine provides better delineation of the small bowel and rectosigmoid compared to Bisacodyl, which in turn, provides better delineation of the rectosigmoid compared to no medication. Moreover, Bisacodyl causes rectal wall edema in the majority of cases.

Measuring surgical safety during minimally invasive surgical procedures: a validation study.

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.

Surgical flow disturbances in dedicated minimally invasive surgery suites: an observational study to assess its supposed superiority over conventional suites.

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.

A dynamic quality assessment tool for laparoscopic hysterectomy to measure surgical outcomes.

BACKGROUND: The current healthcare 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 healthcare 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 healthcare providers may not be valid OBJECTIVE: 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 (.www.qusum.org) was developed with three main goals: to measure the surgeon's performance using three primary outcomes (blood loss, operative time, and complications); to provide immediate individual feedback using cumulative Observed-minus-Expected graphs; and 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±163ml, 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. CONCLUSIONS: 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.

A dynamic quality assessment tool for laparoscopic hysterectomy to measure surgical outcomes.

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.

Hysterectomy in very obese and morbidly obese patients: a systematic review with cumulative analysis of comparative studies.

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.

Learning from visual force feedback in box trainers: tissue manipulation in laparoscopic surgery.

BACKGROUND: Currently, task time and errors are often used as performance parameters in laparoscopic training. Training with the focus on task time improvement alone results in fast, but possibly less controlled, instrument movements and therefore suboptimal tissue handling skills. METHODS: Twenty-five medical students were randomly assigned in two groups. Both groups performed a tissue manipulation task six times. During this training session, the time feedback group (n = 13) received real-time visual feedback of the task time. The force feedback group (n = 12) received real-time visual feedback of the tissue manipulation force. After the training sessions, participants in both groups performed an entirely different task without visual feedback. Task time, force, and motion parameters of this posttest were used to compare the technical skills of the medical students. RESULTS: The training data of the group that received force feedback showed a learning curve for the mean and max absolute force, max force area, force volume, task time, and path length of both instruments. The data from the group that received time feedback showed a learning curve for the max force, task time, and path length of both instruments. In the posttest, the parameters of mean absolute force (p = 0.039), max force (p = 0.041), and force volume (p = 0.009) showed a significant difference in favor of the group that received force feedback. CONCLUSIONS: The learning curves and the posttest indicate that training with visual force feedback improves tissue handling skills with no negative effect on the task time and instrument motions. Conventional laparoscopic training with visual time feedback improves instrument motion and task time, but it does not improve tissue manipulation skills.

Visual force feedback improves knot-tying security.

BACKGROUND: Residents in surgical specialties suture multiple wounds in their daily routine and are expected to be able to perform simple sutures without supervision of experienced surgeons. To learn basic suture skills such as needle insertion and knot tying, applying an appropriate magnitude of force in the desired direction is essential. To investigate if training with real-time visual force feedback improves the suture skills of novices, a study was conducted using a training platform that measures all forces exerted on a skin pad, i.e., the ForceTRAP. METHOD: Two groups of novices were trained on this training platform during a suture task. One group (nov-c) received no visual force feedback during training, whereas the test group (nov-t) trained with visual feedback. The posttest and follow-up test were performed without visual force feedback. RESULTS: A significant difference in reaction force, (nov-c: mean 2.47N standard deviation [SD] ± 0.62, nov-t: mean 1.79N SD ± 0.37), suture strength (nov-c: median 25N interquartile range (IQR) 15, nov-t: median 50N interquartile range 25), and task time (nov-c: mean 109s SD ± 22, nov-t: mean 134s SD ± 31) was found between the control and training group of the posttest. CONCLUSION: Participants that are trained with visual force feedback produce the most secure knots in the posttest and their suturing results in lower applied forces. Therefore, the results of this study indicate that visual force feedback supports students while learning to insert the needle smoothly, to effectively align the suture threads and to balance the force between instruments during knot tying. However, for long-term learning effects, probably more than 1 training session is required.

An alternative approach for removal of placental remnants: hysteroscopic morcellation.

STUDY OBJECTIVE: To evaluate our initial experience with hysteroscopic morcellation for removal of placental remnants. DESIGN: Retrospective case series (Canadian Task Force classification II-3). SETTING: University hospital and 2 teaching hospitals. PATIENTS: Women with histologic confirmation of placental remnants after miscarriage, termination of pregnancy, or delivery. INTERVENTION: From January 2005 to May 2010, hysteroscopic morcellation was used for removal of placental remnants. Retrospective review of medical records was performed. MEASUREMENTS AND MAIN RESULTS: Analysis of 105 procedures was performed. In 99 procedures (94.3%), placental remnants were removed successfully at the first approach, and 90 procedures (85.7%) were without any adverse events. In 6 patients (5.7%), uterine perforation occurred, in 4 during cervical dilation and in 2 during the hysteroscopic procedure. Postoperatively, 3 patients had fever, 1 had hemorrhage, and 1 had abdominal pain. Routine second-look hysteroscopy in 23 patients revealed mild intrauterine adhesions in 1 patient (4.4%). CONCLUSION: Hysteroscopic morcellation seems to be an effective technique for management of placental remnants. Future studies comparing various surgical treatment methods are needed to define factors that influence the ability to obtain the safest and most complete removal of placental remnants because this remains a challenging pregnancy-related condition.

Achieving consensus on the definition of conversion to laparotomy: a Delphi study among general surgeons, gynecologists, and urologists.

BACKGROUND: In laparoscopic surgery, conversion to laparotomy is associated with worse clinical outcomes, especially if the conversion is due to a complication. Although apparently important, no commonly used definition of conversion exists. The aim of this study was to achieve multidisciplinary consensus on a uniform definition of conversion. METHODS: On the basis of definitions currently used in the literature, a web-based Delphi consensus study was conducted among members of all four Dutch endoscopic societies. The rate of agreement (RoA) was calculated; a RoA of >70% suggested consensus. RESULTS: The survey was completed by 268 respondents in the first Delphi round (response rate, 45.6%); 43% were general surgeons, 49% gynecologists, and 8% urologists. Average ± standard deviation laparoscopic experience was 12.5 ± 7.2 years. On the basis of the results of round 1, a consensus definition was compiled. Conversion to laparotomy is an intraoperative switch from a laparoscopic to an open abdominal approach that meets the criteria of one of the two subtypes: strategic conversion, a standard laparotomy that is made directly after the assessment of the feasibility of completing the procedure laparoscopically and because of anticipated operative difficulty or logistic considerations; and reactive conversion, the need for a laparotomy because of a complication or (extension of an incision) because of (anticipated) operative difficulty after a considerable amount of dissection (i.e., >15 min in time). A laparotomy after a diagnostic laparoscopy (i.e., to assess the curability of the disease) should not be considered a conversion. In the second Delphi round, a RoA of 90% was achieved with this definition. CONCLUSIONS: After two Delphi rounds, consensus on a uniform multidisciplinary definition of conversion was achieved within a representative group of general surgeons, gynecologists, and urologists. An unambiguous interpretation will result in a more reliable clinical registration of conversion and scientific evaluation of the feasibility of a laparoscopic procedure.

Clinical relevance of conversion rate and its evaluation in laparoscopic hysterectomy.

STUDY OBJECTIVES: To estimate the current conversion rate in laparoscopic hysterectomy (LH); to estimate the influence of patient, procedure, and performer characteristics on conversion; and to hypothesize the extent to which conversion rate can act as a means of evaluation in LH. DESIGN: Prospective cohort study (Canadian Task Force classification II-2). SETTING: The study included 79 gynecologists representing 42 hospitals throughout the Netherlands. This reflects 75% of all gynecologists performing LH in the Netherlands, and 68% of all hospitals. PATIENTS: Data from 1534 LH procedures were collected between 2008 and 2010. INTERVENTION: All participants in the nationwide LapTop registration study recorded each consecutive LH they performed during 1 year. MEASUREMENTS AND MAIN RESULTS: Conversion rate and odds ratios (OR) of risk factors for conversion were calculated. Conversions were described as reactive or strategic. The literature reported a conversion rate for LH of 0% to 19% (mean, 3.5%). In our cohort, 70 LH procedures (4.6%) were converted. Using a mixed-effects logistic regression model, we estimated independent risk factors for conversion. Body mass index (BMI) (p = .002), uterus weight (p < .001), type of LH (p = .004), and age (p = .02) had a significant influence on conversion. The risk of conversion was increased at BMI >35 (OR, 6.53; p < .001), age >65 years (OR, 6.97; p = .007), and uterus weight 200 to 500 g (OR, 4.05; p < .001) and especially >500 g (OR, 30.90; p < .001). A variation that was not explained by the covariates included in our model was identified and referred to as the "surgical skills factor" (average OR, 2.79; p = .001). CONCLUSION: Use of estimated risk factors (BMI, age, uterus weight, and surgical skills) provides better insight into the risk of conversion. Conversion rate can be used as a means of evaluation to ensure better outcomes of LH in future patients.

Predictors of successful surgical outcome in laparoscopic hysterectomy.

OBJECTIVE: To estimate, after correction for patient factors, to what extent blood loss, operative time, and adverse events are decisive factors for the successful outcome of laparoscopic hysterectomy. A secondary objective was to estimate to what extent a successful outcome can be predicted from surgical experience or other measures of surgical skill. METHODS: A nationwide multivariate 1-year cohort analysis was conducted with gynecologists who perform laparoscopic hysterectomy. The primary outcomes were blood loss, operative time, and adverse events. The procedures were corrected for multiple covariates in a mixed-effects logistic regression model. Furthermore, all primary outcomes were related to experience and the influence of individual surgical skills factors. RESULTS: One thousand five hundred thirty-four laparoscopic hysterectomies were analyzed for 79 surgeons. The success of the surgical outcome was significantly influenced by uterus weight, body mass index, American Society of Anesthesiologists Physical Status Classification, previous abdominal surgeries, and the type of laparoscopic hysterectomy. Surgical experience also predicted the successful outcome of laparoscopic hysterectomy with respect to blood loss and adverse events (P=.048 and .036, respectively). A significant improvement in surgical outcomes tends to continue up to approximately 125 procedures. Independently from surgical experience, an individual surgical skills factor was identified as odds ratio 1.67 and 3.60 for blood loss and operative time, respectively. CONCLUSION: After adjusting for risk factors, it was shown that an increase in experience positively predicted a successful outcome in laparoscopic hysterectomy with respect to blood loss and adverse events. However, the independent surgical skills factor shows a large variation in proficiency between individuals. The fact that a surgeon has performed many laparoscopic hysterectomies does not necessarily guarantee good surgical outcome. LEVEL OF EVIDENCE: II.

[Safe introduction of laparoscopic hysterectomy using a mentor]. / Veilige introductie van laparoscopische hysterectomie met een mentor.

OBJECTIVE: Evaluation of the introduction of laparoscopic hysterectomy in a teaching hospital by means of a structured mentor-traineeship. DESIGN: Retrospective, with prospectively designed database. METHODS: By means of a mentor-traineeship the technique of laparoscopic hysterectomy was introduced to two gynaecologists in a teaching hospital. The primary outcome measures of the laparoscopic hysterectomies were duration of the operation, blood loss and complications. In addition, patient characteristics as well as main indication for surgery were analysed. The training period was defined per trainee as the relationship between operation duration and consecutive operations. Similar outcome measures of all laparoscopic hysterectomies performed during the same period by the mentor in his own hospital were used as a reference. RESULTS: During both mentor-traineeships, the main indication for surgery, the operation characteristics and the percentage of complications were comparable between trainee and mentor (p = 0.633). The operating time did not differ clinically significantly between trainee and mentor. Both trainees realised a learning curve, while the operating time remained statistically constant and comparable to that of the mentor. During the mentor-traineeships and the two following years the number of laparoscopic hysterectomies increased (p = 0.001), while the number of abdominal hysterectomies diminished (p = 0.002). CONCLUSION: A mentor was able to effectively introduce laparoscopic hysterectomy in a clinic without jeopardizing patient safety, as main indication, operating time and percentage of complications were comparable to those of the mentor in his/her own hospital. Due to this safe method of introduction of the new procedure more patients are able to benefit from the advantages of this surgical technique.