Pulmonary oedema in the course of severe maternal outcome in South Africa: A cohort study combined with clinical audit.

OBJECTIVES: To describe the incidence and outcomes of pulmonary oedema in women with severe maternal outcome during childbirth and identify possible modifiable factors through audit. METHODS: All women with severe maternal outcome (maternal deaths or near misses) who were referred to Tygerberg referral hospital from health facilities in Metro East district, South Africa, during 2014-2015 were included. Women with severe maternal outcome and pulmonary oedema during pregnancy or childbirth were evaluated using three types of critical incident audit: criterion-based case review by one consultant gynaecologist, monodisciplinary critical incident audit by a team of gynaecologists, multidisciplinary audit with expert review from anaesthesiologists and cardiologists. RESULTS: Of 32,161 pregnant women who gave birth in the study period, 399 (1.2%) women had severe maternal outcome and 72/399 (18.1%) had pulmonary oedema with a case fatality rate of 5.6% (4/72). Critical incident audit demonstrated that pre-eclampsia/HELLP-syndrome and chronic hypertension were the main conditions underlying pulmonary oedema (44/72, 61.1%). Administration of volumes of intravenous fluids in already sick women, undiagnosed underlying cardiac illness, administration of magnesium sulphate as part of pre-eclampsia management and oxytocin for augmentation of labour were identified as possible contributors to the pathophysiology of pulmonary oedema. Women-related factors (improved antenatal care attendance) and health care-related factors (earlier diagnosis and management) would potentially have improved maternal outcome. CONCLUSIONS: Although pulmonary oedema in pregnancy is rare, among women with severe maternal outcome a considerable proportion had pulmonary oedema (18.1%). Audit identified options for prevention of pulmonary oedema and improved outcome. These included early detection and management of preeclampsia with close monitoring of fluid intake and cardiac evaluation in case of suspected pulmonary oedema. Therefore, a multidisciplinary clinical approach is recommended.

Great saves or near misses? Severe maternal outcome in Metro East, South Africa: A region-wide population-based case-control study.

OBJECTIVE: To assess the incidence of severe maternal outcome (SMO), comprising maternal mortality (MM) and maternal near miss (MNM), in Metro East health district, Western Cape Province, South Africa between November 2014 and November 2015 and to identify associated determinants leading to SMO with the aim to improve maternity care. METHODS: Region-wide population-based case-control study. Women were included in the study, if they were maternal deaths or met MNM criteria, both as defined by WHO. Characteristics of women with SMO were compared with those of a sample of women without SMO, matched for age and parity, taken from midwifery-led obstetrical units from two residential areas in Metro East, using multivariate regression analysis. RESULTS: Incidence of SMO was 9.1 per 1000 live births, and incidence of MNM was 8.6 per 1000 live births. Main causes of SMO were obstetrical hemorrhage and hypertensive disorders. Factors associated with SMO were HIV (adjusted odds ratio [aOR] 24.8; 95% confidence interval [CI] 10.0-61.6), pre-eclampsia (aOR 17.5; 95% CI 7.9-38.7), birth by cesarean section (aOR 8.4; 95% CI 5.8-12.3), and chronic hypertension (aOR 2.4; 95% CI 1.1-5.1). CONCLUSION: Evaluation of SMO incidence and associated determinants supports optimizing tailored guidelines in Metro-East health district to improve maternal health.

Reproductive Outcomes following Use of Barbed Suture during Laparoscopic Myomectomy.

STUDY OBJECTIVE: To review pregnancy outcomes after laparoscopic myomectomy with the use of barbed suture. DESIGN: Retrospective cohort study and follow-up survey. SETTING: Single, large academic medical center. PATIENTS: Patients who underwent laparoscopic myomectomy with the use of barbed suture for myometrial closure between 2008 and 2016. INTERVENTION: Laparoscopic myomectomy and a follow-up survey regarding pregnancy outcome. MEASUREMENTS AND MAIN RESULTS: A total of 486 patients met inclusion criteria and underwent a laparoscopic myomectomy between 2008 and 2016. Of the 428 with viable contact information, 240 agreed to participate (56%). Of those who responded to the survey, 101 (42%) attempted to get pregnant, and there were 4 unplanned pregnancies. There were 110 pregnancies among 76 survey respondents. In total, of the women attempting a postoperative pregnancy, 71% had at least 1 pregnancy. Comparing the women who did and did not conceive postoperatively, the group who got pregnant was on average younger, 33.8 ± 4.5 years vs 37.5 ± 6.5 years (p = .001); had fewer myomas removed, median = 2 (range 1-9) vs median = 2 (range 1-16) myomas (p = .038); and had a longer follow-up period, 30 months ( vs 30 (11-93 months) ± 20 (p <.001). The mean time to first postoperative pregnancy was 18.0 months (range 2-72 months). Of the 110 reported postoperative pregnancies, there were 60 live births (55%), 90% by means of cesarean section. The mean gestational age at birth was 37.8 weeks. In the cohort, there were 8 preterm births, 3 cases of abnormal placentation, 2 cases of fetal growth restriction, 3 cases of hypertensive disorders of pregnancy, and 2 cases of myoma degeneration requiring hospitalization for pain control. There were no uterine ruptures reported. CONCLUSION: According to our findings, pregnancy outcomes after laparoscopic myomectomy with barbed suture are comparable with available literature on pregnancy outcomes with conventional smooth suture.

Towards spill-free in-bag morcellation: a health failure mode and effects analysis.

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.

Urinary catheterisation management after laparoscopic hysterectomy: a national overview and a nurse preference survey.

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.

Increased single-balloon Foley catheter volume for induction of labor and time to delivery: a systematic review and meta-analysis.

INTRODUCTION: Induction of labor is a common intervention. The objective was to investigate whether larger Foley catheter volumes for labor induction decrease the total time from induction to delivery. MATERIAL AND METHODS: Randomized controlled trials comparing larger single-balloon volumes (60-80 mL) during Foley catheter cervical ripening with usual volume (30 mL) in women undergoing labor induction were identified by searching electronic databases (MEDLINE, Scopus, ClinicalTrials.gov, PROSPERO, EMBASE, Scielo and the Cochrane Central Register of Controlled Trials) from inception through 2017. The primary outcome was mean time from induction to delivery in hours. Secondary outcomes included time from induction to vaginal delivery, delivery within 24 h, time to Foley expulsion, cesarean section, chorioamnionitis, epidural use, hemorrhage, meconium staining, and neonatal intensive care unit admission. Meta-analysis was performed using the random effects model of DerSimonian and Laird (PROSPERO CRD42017058885). RESULTS: Seven randomized controlled trials including 1432 singleton gestations were included in the systematic review. Women randomized to larger volumes of balloon had a significantly shorter time from induction to delivery (mean difference 1.97 h, 95% CI -3.88 to -0.06). There was no difference in cesarean section between groups (16 vs. 18%, relative risk 0.84, 95% CI 0.6-1.17). A larger balloon volume was associated with a nonsignificant decrease in time from induction to delivery in multiparous (mean difference 2.67 h, 95% CI -6.1 to 0.76) and nulliparous women (mean difference 1.82 h, 95% CI -4.16 to 0.53). CONCLUSION: Balloon volumes larger than 30 mL during Foley catheter induction reduce total time to delivery by approximately 2 h.

Reintervention risk and quality of life outcomes after uterine-sparing interventions for fibroids: a systematic review and meta-analysis.

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

Surgical outcomes of laparoscopic hysterectomy with concomitant endometriosis without bowel or bladder dissection: a cohort analysis to define a case-mix variable.

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

Laparoscopic hysterectomy for benign indications: clinical practice guideline.

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.

Medical malpractice claims in laparoscopic gynecologic surgery: a Dutch overview of 20 years.

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.

Foley catheter for induction of labour filled with 30mL or 60mL: A randomized controlled trial.

OBJECTIVES: One of the methods used to induce labour is the placement of a transcervical Foley catheter (FC). The aim of this randomized controlled study was to assess in term pregnant women with an unfavourable cervix, whether there is a difference in efficacy between the two most commonly used insufflation volumes of FC (30mL and 60mL). STUDY DESIGN: Randomized controlled trial. RESULTS: Women were randomized to induction of labour with a Foley catheter filled with 30mL or with 60mL. Primary outcome was delivery within eight hours after amniotomy. Secondary outcomes included the time interval between placement of the Foley and amniotomy, the mode of delivery, complications and neonatal outcomes. In total, 174 women (87 in each arm) were randomized. The number of deliveries within eight hours after amniotomy was not significantly different between the two groups (40.7% versus 48.83%, OR=0.71(CI; 0.39-1.3)). Sub-analysis showed that more multiparous women in the 60mL group delivered within eight hours (93.10% versus 65.22%, OR=7.2 (CI; 1.35-38.37)). For the nulliparous, the 30mL Foley catheter was associated with a higher caesarean section rate (31.75% versus 15.52% (OR 2.53; CI; 1.1-6.2)). The 60mL Foley catheter was also associated with a higher chance of spontaneous labour after placement (OR 2.35; CI; 1.1-5.1), a shorter time interval for cervical ripening (OR=4.5; CI: 1.2-16.7) and less blood loss. (p=0.002). The Foley catheter ruptured twelve times in the 60mL group whereas this did not happen once in the 30mL group. One case of umbilical cord prolapse was observed in the 60mL group. No differences in neonatal outcomes and patient satisfaction were seen. CONCLUSIONS: For our primary outcome, no difference was observed between the Foley catheter balloon filled with 60mL and the one filled with 30mL. Yet, a Foley catheter filled with 60mL was associated in multiparous women with a higher rate of deliveries within eight hours after amniotomy and in nulliparous with a significantly lower caesarean section rate. These latest findings should be interpreted with cautious as underpowered.

Laparoendoscopic single-site surgery versus conventional laparoscopy for hysterectomy: a systematic review and meta-analysis.

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.

Identification of risk factors in minimally invasive surgery: a prospective multicenter study.

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.

Total Laparoscopic Hysterectomy Versus Vaginal Hysterectomy: A Systematic Review and Meta-Analysis.

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.

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.

Case-Mix Variables and Predictors for Outcomes of Laparoscopic Hysterectomy: A Systematic Review.

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.

Power Morcellator Features Affecting Tissue Spill in Gynecologic Laparoscopy: An In-Vitro Study.

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.

Analysis of Risk Factors for Intraoperative Conversion of Laparoscopic Myomectomy.

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.

Molecular changes in endometriosis-associated ovarian clear cell carcinoma.

BACKGROUND: Endometriosis is frequently associated with and thought of having propensity to develop into ovarian clear cell carcinoma (OCCC), although the molecular transformation mechanism is not completely understood. METHODS: We employed immunohistochemical (IHC) staining for marker expression along the potential progression continuum. Expression profiling of microdissected endometriotic and OCCC cells from patient-matched formalin-fixed, paraffin-embedded samples was performed to explore the carcinogenic pathways. Function of novel biomarkers was confirmed by knockdown experiments. RESULTS: PTEN was significantly lost in both endometriosis and invasive tumour tissues, while oestrogen receptor (ER) expression was lost in OCCC relative to endometriosis. XRCC5, PTCH2, eEF1A2 and PPP1R14B were significantly overexpressed in OCCC and associated endometriosis, but not in benign endometriosis (p ⩽ 0.004). Knockdown experiments with XRCC5 and PTCH2 in a clear cell cancer cell line resulted in significant growth inhibition. There was also significant silencing of a panel of target genes with histone H3 lysine 27 trimethylation, a signature of polycomb chromatin-remodelling complex in OCCC. IHC confirmed the loss of expression of one such polycomb target gene, the serous ovarian cancer lineage marker Wilms' tumour protein 1 (WT1) in OCCC, while endometriotic tissues showed significant co-expression of WT1 and ER. CONCLUSIONS: Loss of PTEN expression is proposed as an early and permissive event in endometriosis development, while the loss of ER and polycomb-mediated transcriptional reprogramming for pluripotency may play an important role in the ultimate transformation process. Our study provides new evidence to redefine the pathogenic programme for lineage-specific transformation of endometriosis to OCCC.