STUDY QUESTION What is the additional value of the comprehensive complication index (CCI) and ClassIntra system (classification for intraoperative adverse events (ioAEs)) in adverse event (AE)... Show moreSTUDY QUESTION What is the additional value of the comprehensive complication index (CCI) and ClassIntra system (classification for intraoperative adverse events (ioAEs)) in adverse event (AE) reporting in (deep) endometriosis (DE) surgery compared to only using the Clavien-Dindo (CD) system? SUMMARY ANSWER The CCI and ClassIntra are useful additional tools alongside the CD system for a complete and uniform overview of the total AE burden in patients with extensive surgery (such as DE), and with this uniform data registration, it is possible to provide greater insight into the quality of care. WHAT IS KNOWN ALREADY Uniform comparison of AEs reported in the literature is hampered by scattered registration. In endometriosis surgery, the usage of the CD complication system and the CCI is internationally recommended; however, the CCI is not routinely adapted in endometriosis care and research. Furthermore, a recommendation for ioAEs registration in endometriosis surgery is lacking, although this is vital information in surgical quality assessments. STUDY DESIGN, SIZE, DURATION A prospective mono-center study was conducted with 870 surgical DE cases from a non-university DE expertise center between February 2019 and December 2021. PARTICIPANTS/MATERIALS, SETTING, METHODS Endometriosis cases were collected with the EQUSUM system, a publicly available web-based application for registration of surgical procedures for endometriosis. Postoperative adverse events (poAEs) were classified with the CD complication system and CCI. Differences in reporting and classifying AEs between the CCI and the CD were assessed. ioAEs were assessed with the ClassIntra. The primary outcome measure was to assess the additional value toward the CD classification with the introduction of the CCI and ClassIntra. In addition, we report a benchmark for the CCI in DE surgery. MAIN RESULTS AND THE ROLE OF CHANCE A total of 870 DE procedures were registered, of which 145 procedures with one or more poAEs, resulting in a poAE rate of 16.7% (145/870), of which in 36 cases (4.1%), the poAE was classified as severe (>= Grade 3b). The median CCI (interquartile range) of patients with poAEs was 20.9 (20.9-31.7) and 33.7 (33.7-39.7) in the group of patients with severe poAEs. In 20 patients (13.8%), the CCI was higher than the CD because of multiple poAEs. There were 11 ioAEs reported (11/870, 1.3%) in all procedures, mostly minor and directly repaired serosa injuries. LIMITATIONS, REASONS FOR CAUTION This study was conducted at a single center; thus, trends in AE rates and type of AEs could differ from other centers. Furthermore, no conclusion could be drawn on ioAEs in relation to the postoperative course because the power of this database is not robust enough for that purpose. WIDER IMPLICATIONS OF THE FINDINGS From our data, we would advise to use the Clavien-Dindo classification system together with the CCI and ClassIntra for a complete overview of AE registration. The CCI appeared to provide a more complete overview of the total burden of poAEs compared to only reporting the most severe poAEs (as with CD). If the use of the CD, CCI, and ClassIntra is widely adapted, uniform data comparison will be possible at (inter)national level, providing better insight into the quality of care. Our data could be used as a first benchmark for other DE centers to optimize information provision in the shared decision-making process. STUDY FUNDING/COMPETING INTEREST(S) No funding was received for this study.The authors have no conflicts of interest to declare. Show less
Background: Deep Endometriosis (DE) classification studies with Enzian never compared solitary (A, B, C, F), and combinations of anatomical locations (A&B, A&C, B&C, A&B&C), in... Show moreBackground: Deep Endometriosis (DE) classification studies with Enzian never compared solitary (A, B, C, F), and combinations of anatomical locations (A&B, A&C, B&C, A&B&C), in correlation to pain. Therefore, the results of these studies are challenging to translate to the clinical situation.Objectives: We studied pain symptoms and their correlation with the solitary and combinations of anatomical locations of deep endometriosis lesion(s) classified by the Enzian score.Materials and Methods: A prospective multi-centre study was conducted with data from university and non -university hospitals. A total of 419 surgical DE cases were collected with the web-based application called EQUSUM (www.equsum.org).Main outcome measures: Preoperative reported numeric rating scale (NRS) were collected along with the Enzian classification. Baseline characteristics, pain scores, surgical procedure and extent of the disease were also collected.Results: In general, more extensive involvement of DE does not lead to an increase in the numerical rating scale for pain measures. However, dysuria and bladder involvement do show a clear correlation AUC 0.62 (SE 0.04, CI 0.54-0.71, p< 0.01). Regarding the predictive value of dyschezia, we found a weak, but significant correlation with ureteric involvement; AUC 0.60 (SE 0.04, CI 0.53-0.67, p< 0.01).Conclusions:TPain symptoms poorly correlate with anatomical locations of deep endometriosis in almost all pain scores, with the exception of bladder involvement and dysuria which did show a correlation. Also, dyschezia seems to have predictive value for DE ureteric involvement and therefore MRI or ultrasound imaging (ureter and kidney) could be recommended in the preoperative workup of these patients.What's new? Dyschezia might have a predictive value in detecting ureteric involvement. Show less
Background: Subfertility occurs in 30-40% of endometriosis patients. Regarding the fertilisation rate with in vitro fertilisation (IVF) and endometriosis, conflicting data has been published. This... Show moreBackground: Subfertility occurs in 30-40% of endometriosis patients. Regarding the fertilisation rate with in vitro fertilisation (IVF) and endometriosis, conflicting data has been published. This study aimed to compare endometriosis patients to non-endometriosis cycles assessing fertilisation rates in IVF.Methods: A population-based cohort study was conducted at the Leiden University Medical Center. IVF cycles of endometriosis patients and controls (unexplained infertility and tubal pathology) were analysed. The main outcome measurement was fertilisation rate.Results: 503 IVF cycles in total, 191 in the endometriosis group and 312 in the control. The mean fertilisation rate after IVF did not differ between both groups, 64.1%+/- 25.5 versus 63.9%+/- 24.8 (p=0.95) respectively, independent of age and r-ASRM classification. The median number of retrieved oocytes was lower in the endometriosis group (7.0 versus 8.0 respectively, p=0.19) and showed a significant difference when corrected for age (p=0.02). When divided into age groups, the statistical effect was only seen in the group of <= 35 years (p=0.04). In the age group <= 35, the endometriosis group also showed significantly more surgery on the internal reproductive organs compared to the control group (p<0.001). All other outcomes did not show significant differences.Conclusion: Similar fertilisation rates were found in endometriosis IVF cycles compared to controls. The oocyte retrieval was lower in the endometriosis group, however this effect was only significant in the age group <= 35 years. All other secondary outcomes did not show significant differences. In general, endometriosis patients with an IVF indication can be counselled positively regarding the chances of becoming pregnant, and do not need a different IVF approach. Show less
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... Show moreBACKGROUND 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. Show less
Although hospitals increasingly opt for the laparoscopic over the conventional approach and the decline in diagnostic procedures is well compensated by an increase in numbers of all types of... Show moreAlthough hospitals increasingly opt for the laparoscopic over the conventional approach and the decline in diagnostic procedures is well compensated by an increase in numbers of all types of therapeutic procedures, the implementation of laparoscopic hysterectomy in the Netherlands seems to be hampered and scattered (chapter 2). The majority of hospitals that apply laparoscopic hysterectomy perform only a minority of the total volume of procedures, whereas the minority of hospitals performs a high annual caseload of procedures. From our studies, preference and referral tendencies seem to be suboptimal, despite knowledge indication and advantages of this minimally invasive technique (chapter 4). Gynecologists employed in a hospital that did not perform laparoscopic hysterectomies were much less likely to refer candidates for this procedure, despite basic knowledge about the indication and limitations of the approach. Furthermore, patient related factors, such as body mass index and uterus weight, might play a role in this tendency. The level of experience (expressed in number of laparoscopic hysterectomies performed) did not significantly influence the laparoscopist__s opinion on body mass index, uterus weight and previous abdominal surgery as restrictive characteristics for the laparoscopic approach. Both, performers as well as referring colleagues regarded a high body mass index, big uterus weight and previous abdominal surgery as restricting parameters for the laparoscopic approach. This is worrisome, as we know that the majority of these __challenging__ patients have an uneventful procedure (85%) and especially since there is evidence that the obese patient is better served by a laparoscopic approach than by conventional abdominal surgery. Furthermore, it was shown that with growing popularity of this procedure (half of laparoscopic hysterectomy performing gynecologists had less than five years experience), a steady state of implementation of this advanced laparoscopic surgical procedure has yet not been reached. The Laparoscopic Assisted Vaginal Hysterectomy (LAVH), a variant of laparoscopic hysterectomy, showed to be generally performed by inexperienced surgeons in low volume hospitals, while adverse events and blood loss were increased compared to Total Laparoscopic Hysterectomy (chapter 3 and chapter 5). In our prospective study in 79 surgeons (the LapTop! study), we observed that the success of surgical outcomes was significantly influenced by uterus weight, body mass index, ASA classification and previous abdominal surgeries, next to the type of laparoscopic hysterectomy (chapter 5). Surgical experience also predicted the successful outcome of laparoscopic hysterectomy with respect to blood loss and adverse events. However, also an experience independent surgical skills factor was identified, representing a crucial determinant in measuring quality of surgery. This skills factor was also present in the probability of conversion to laparotomy in the same cohort (chapter 6). The majority of conversions were performed because of strategic considerations, while uncontrollable bleeding was the main adverse event leading to a reactive conversion. A high body mass index and increased uterus weight predicted conversion probability, while experience did not.vaginal and abdominal hysterectomy (chapter 7). Therefore, minimally invasive surgery is not necessarily minimally painful. However, patients in the minimally invasive group reported a steeper decline in pain scores postoperatively. Acquiring and maintaining skills in laparoscopic hysterectomy by mentorship showed to be effective, safe and durable, as indication, operative time and adverse event rates were comparable to those of the mentor in his own hospital during and after completing the mentorship program (chapter 8). Assessment of skills in advanced laparoscopic surgery is increasingly demanded. Prediction of surgical skills based on __in vitro__ box trainers outcomes was not conclusive as surgeons with suboptimal average clinical outcomes could not be indicated by means of a box trainer task (chapter 9). However, __real time__ risk-adjusted clinical monitoring of performance by means of cumulative sum (CUSUM) analysis appeared to be a valuable tool in order to signal derailing performance in a timely fashion (chapter 10). This is paramount, as in laparoscopic hysterectomy no definitive accomplishment of the proficiency curve is foreseen and applying relevant predictors of quality of surgery should guard patient safety. Show less
Study Objectives: To compare preferences for laparoscopic hysterectomy (LH) over abdominal hysterectomy (AH) by gynecologists who perform LH (group 1), their colleagues (group 2), and gynecologists... Show moreStudy Objectives: To compare preferences for laparoscopic hysterectomy (LH) over abdominal hysterectomy (AH) by gynecologists who perform LH (group 1), their colleagues (group 2), and gynecologists employed by a hospital that does not provide LH (group 3), and to estimate boundary values of patient characteristics that influence preference for mode of hysterectomy. Differences in referral tendencies between groups 2 and 3 are compared. Design: Group comparison study (Canadian Task Force classification II-2). Setting: Nationwide conjoint preference study in groups 1, 2, and 3. Intervention: Web-based choice-based conjoint analysis questionnaire. Measurements and Main Results: In general, group I preferred LH significantly more often (86.3%; 95% confidence interval [Cl], 81.6-91.0) than did group 2 (70.9%; 95% CI, 63.4-78.4). Group 3 preferred LH significantly less frequently (50.3%; 95% CI, 35.7-64.9). Increases in body mass index, estimated uterus size, and number of previous abdominal surgeries caused a significant drop in shares of preferences in all groups. Conclusions: The presence of a gynecologist who performs LH positively influences the referral behavior of colleagues. The effect of an increased body mass index seems to be a restrictive parameter for choosing LH according to both referring gynecologists and those who perform LH. Level of experience does not influence preference of laparoscopists. The observed discrepancy between reported and simulated referral behavior in group 3 demonstrates that practical impediments significantly decrease referral tendencies, consequently hampering implementation of this minimally invasive approach. Journal of Minimally Invasive Gynecology (2011) 18, 582-588 (C) 2011 AAGL. All rights reserved. Show less
Background: To evaluate the implementation and maintenance of advanced laparoscopic skills after a structured mentorship program in laparoscopic hysterectomy (LH). Methods: Cohort retrospective... Show moreBackground: To evaluate the implementation and maintenance of advanced laparoscopic skills after a structured mentorship program in laparoscopic hysterectomy (LH). Methods: Cohort retrospective analysis of 104 successive LHs performed by two gynecologists during and after a mentorship program. LHs were compared for indication, patient characteristics and intraoperative characteristics. As a frame of reference, 94 LHs performed by the mentor were analyzed. Results: With regard to indication, blood loss and adverse outcomes, both trainees performed LHs during their mentorship program comparable with the LHs performed by the mentor. The difference in mean operating time between trainees and mentor was not clinically significant. Both trainees progressed along a learning curve, while operating time remained statistically constant and comparable to that of the mentor. After completing the mentorship program, both gynecologists maintained their acquired skills as blood loss, adverse outcome rates and operating time were comparable with the results during their traineeship. Conclusion: A mentorship program is an effective and durable tool for implementing a new surgical procedure in a teaching hospital with respect to patient safety aspects, as indications, operating time and adverse outcome rates are comparable to those of the mentor in his own hospital during and after completing the mentorship program. Copyright (C) 2010 S. Karger AG, Basel Show less
Study Objective: To estimate the implementation of laparoscopic surgery in operative gynecology. Design: Observational multicenter study (Canadian Task Force classification II-2). Setting: All... Show moreStudy Objective: To estimate the implementation of laparoscopic surgery in operative gynecology. Design: Observational multicenter study (Canadian Task Force classification II-2). Setting: All hospitals in the Netherlands. Sample: Nationwide annual statistics for 2002 and 2007. Interventions: A national survey of the number of performed laparoscopic and conventional procedures was performed. Laparoscopy was categorized for complexity in level 1, 2, and 3 procedures. Outcomes were compared with results from 2002 to evaluate trends. Measurements and Main Results: In 2002, 21 414 laparoscopic and 9325 conventional procedures were performed in 74 hospitals (response rate, 74%), and in 2007, 16 863 laparoscopic and 10 973 conventional procedures were performed in 80 hospitals (response rate, 80%). Compared with 2002, in 2007, level 1 procedures were performed significantly less often and level 2 and level 3 procedures were performed significantly more often. The mean number of performed laparoscopic procedures per hospital decreased from 289 to 211 procedures. Teaching hospitals performed more than twice as many therapeutic laparoscopic procedures as nonteaching hospitals do. Cystectomy, oophorectomy, and ectopic pregnancy surgery were preferably performed using the laparoscopic approach. Laparoscopic hysterectomy was performed significantly more often, accounting for 10% of all hysterectomies. Annually, 20% of hospitals in which laparoscopic hysterectomy was implemented performed 50% of all laparoscopic hysterectomies, and 50% of the hospitals performed 20% of laparoscopic hysterectomies. Conclusion: This study describes increasing implementation of therapeutic laparoscopic gynecologic surgery. Clinics increasingly opt to perform laparoscopic surgery rather than conventional surgery. However, implementation of advanced procedures such as laparoscopic hysterectomy seems to be hampered. journal of Minimally Invasive Gynecology (2010) 17, 487-492 (c) 2010 AAGL. All rights reserved. Show less
Objective The central aim of this study was to assess the feasibility of the developed adverse outcome registration method. Furthermore, it was tested whether the information gathered through the... Show moreObjective The central aim of this study was to assess the feasibility of the developed adverse outcome registration method. Furthermore, it was tested whether the information gathered through the registration system allowed for comparative analyses. Design Prospective observational multicentre study. Setting The obstetrics and gynaecology departments of three Dutch university and three general hospitals. Population Every consecutive admission to these departments during the 12-month study period. Methods All complications, during admission and up to 6 weeks after discharge, were registered using a standardised form. The complication type and origin were noted and the severity of the complications were graded. Main outcome measures The differences in relative frequencies of complications between the participating university and general hospitals. Results A total of 10 470 admissions were observed at the obstetrics and gynaecology departments of the six hospitals combined. The standard complication registration form was completed for approximately 90% of these admissions. A total of 351 gynaecological (9.1%) and 960 obstetrical (14.5%) complications were reported. There was no significant difference in the percentage of complications between general hospitals and university hospitals. The severity of complications, however, varied significantly between the participating hospitals. Conclusions A feasible framework for complication registration in the field of obstetrics and gynaecology has been developed. Before comparing frequencies of adverse events between hospitals, such outcome measures first need to be risk-adjusted to overcome the problem of patient variation and acuity between hospitals as a source of difference, leaving quality of care as a primary source of variation. Show less
