Browsing by Author "Jelovsek, J Eric"
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Item Open Access A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery.(Obstetrics and gynecology, 2014-02) Jelovsek, J Eric; Chagin, Kevin; Brubaker, Linda; Rogers, Rebecca G; Richter, Holly E; Arya, Lily; Barber, Matthew D; Shepherd, Jonathan P; Nolen, Tracy L; Norton, Peggy; Sung, Vivian; Menefee, Shawn; Siddiqui, Nazema; Meikle, Susan F; Kattan, Michael W; Pelvic Floor Disorders NetworkTo construct and validate a prediction model for estimating the risk of de novo stress urinary incontinence (SUI) after vaginal pelvic organ prolapse (POP) surgery and compare it with predictions using preoperative urinary stress testing and expert surgeons' predictions.Using the data set (n=457) from the Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial, a model using 12 clinical preoperative predictors of de novo SUI was constructed. De novo SUI was determined by Pelvic Floor Distress Inventory responses through 12 months postoperatively. After fitting the multivariable logistic regression model using the best predictors, the model was internally validated with 1,000 bootstrap samples to obtain bias-corrected accuracy using a concordance index. The model's predictions were also externally validated by comparing findings against actual outcomes using Colpopexy and Urinary Reduction Efforts trial patients (n=316). The final model's performance was compared with experts using a test data set of 32 randomly chosen Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial patients through comparison of the model's area under the curve against: 1) 22 experts' predictions; and 2) preoperative prolapse reduction stress testing.A model containing seven predictors discriminated between de novo SUI status (concordance index 0.73, 95% confidence interval [CI] 0.65-0.80) in Outcomes Following Vaginal Prolapse Repair and Midurethral Sling participants and outperformed expert clinicians (area under the curve 0.72 compared with 0.62, P<.001) and preoperative urinary stress testing (area under the curve 0.72 compared with 0.54, P<.001). The concordance index for Colpopexy and Urinary Reduction Efforts trial participants was 0.62 (95% CI 0.56-0.69).This individualized prediction model for de novo SUI after vaginal POP surgery is valid and outperforms preoperative stress testing, prediction by experts, and preoperative reduction cough stress testing. An online calculator is provided for clinical use.III.Item Open Access A model to predict risk of blood transfusion after gynecologic surgery.(Am J Obstet Gynecol, 2017-05) Stanhiser, Jamie; Chagin, Kevin; Jelovsek, J EricBACKGROUND: A model that predicts a patient's risk of receiving a blood transfusion may facilitate selective preoperative testing and more efficient perioperative blood management utilization. OBJECTIVE: We sought to construct and validate a model that predicts a patient's risk of receiving a blood transfusion after gynecologic surgery. STUDY DESIGN: In all, 18,319 women who underwent gynecologic surgery at 10 institutions in a single health system by 116 surgeons from January 2010 through June 2014 were analyzed. The data set was split into a model training cohort of 12,219 surgeries performed from January 2010 through December 2012 and a separate validation cohort of 6100 surgeries performed from January 2013 through June 2014. In all, 47 candidate risk factors for transfusion were collected. Multiple logistic models were fit onto the training cohort to predict transfusion within 30 days of surgery. Variables were removed using stepwise backward reduction to find the best parsimonious model. Model discrimination was measured using the concordance index. The model was internally validated using 1000 bootstrapped samples and temporally validated by testing the model's performance in the validation cohort. Calibration and decision curves were plotted to inform clinicians about the accuracy of predicted probabilities and whether the model adds clinical benefit when making decisions. RESULTS: The transfusion rate in the training cohort was 2% (95% confidence interval, 1.72-2.22). The model had excellent discrimination and calibration during internal validation (bias-corrected concordance index, 0.906; 95% confidence interval, 0.890-0.928) and maintained accuracy during temporal validation using the separate validation cohort (concordance index, 0.915; 95% confidence interval, 0.872-0.954). Calibration curves demonstrated the model was accurate up to 40% then it began to overpredict risk. The model provides superior net benefit when clinical decision thresholds are between 0-50% predicted risk. CONCLUSION: This model accurately predicts a patient's risk of transfusion after gynecologic surgery facilitating selective preoperative testing and more efficient perioperative blood management utilization.Item Open Access Are prediction models for vaginal birth after cesarean accurate?(American journal of obstetrics and gynecology, 2019-05) Harris, Benjamin S; Heine, R Phillips; Park, Jinyoung; Faurot, Keturah R; Hopkins, Maeve K; Rivara, Andrew J; Kemeny, Hanna R; Grotegut, Chad A; Jelovsek, J EricBACKGROUND:The use of trial of labor after cesarean delivery calculators in the prediction of successful vaginal birth after cesarean delivery gives physicians an evidence-based tool to assist with patient counseling and risk stratification. Before deployment of prediction models for routine care at an institutional level, it is recommended to test their performance initially in the institution's target population. This allows the institution to understand not only the overall accuracy of the model for the intended population but also to comprehend where the accuracy of the model is most limited when predicting across the range of predictions (calibration). OBJECTIVE:The purpose of this study was to compare 3 models that predict successful vaginal birth after cesarean delivery with the use of a single tertiary referral cohort before continuous model deployment in the electronic medical record. STUDY DESIGN:All cesarean births for failed trial of labor after cesarean delivery and successful vaginal birth after cesarean delivery at an academic health system between May 2013 and March 2016 were reviewed. Women with a history of 1 previous cesarean birth who underwent a trial of labor with a term (≥37 weeks gestation), cephalic, and singleton gestation were included. Women with antepartum intrauterine fetal death or fetal anomalies were excluded. The probability of successful vaginal birth after cesarean delivery was calculated with the use of 3 prediction models: Grobman 2007, Grobman 2009, and Metz 2013 and compared with actual vaginal birth after cesarean delivery success. Each model's performance was measured with the use of concordance indices, Brier scores, and calibration plots. Decision curve analysis identified the range of threshold probabilities for which the best prediction model would be of clinical value. RESULTS:Four hundred four women met the eligibility criteria. The observed rate of successful vaginal birth after cesarean delivery was 75% (305/404). Concordance indices were 0.717 (95% confidence interval, 0.659-0.778), 0.703 (95% confidence interval, 0.647-0.758), and 0.727 (95% confidence interval, 0.669-0.779), respectively. Brier scores were 0.172, 0.205, and 0.179, respectively. Calibration demonstrated that Grobman 2007 and Metz vaginal birth after cesarean delivery models were most accurate when predicted probabilities were >60% and were beneficial for counseling women who did not desire to have vaginal birth after cesarean delivery but had a predicted success rates of 60-90%. The models underpredicted actual probabilities when predicting success at <60%. The Grobman 2007 and Metz vaginal birth after cesarean delivery models provided greatest net benefit between threshold probabilities of 60-90% but did not provide a net benefit with lower predicted probabilities of success compared with a strategy of recommending vaginal birth after cesarean delivery for all women . CONCLUSION:When 3 commonly used vaginal birth after cesarean delivery prediction models are compared in the same population, there are differences in performance that may affect an institution's choice of which model to use.Item Open Access Assessing intraoperative judgment using script concordance testing through the gynecology continuum of practice.(Med Teach, 2014-08) Kow, Nathan; Walters, Mark D; Karram, Mickey M; Sarsotti, Carlos J; Jelovsek, J EricOBJECTIVE: To measure surgical judgment across the Obstetrics and Gynecology (OBGYN) continuum of practice and identify factors that correlate with improved surgical judgment. METHODS: A 45-item written examination was developed using script concordance theory, which compares an examinee's responses to a series of "ill-defined" surgical scenarios to a reference panel of experts. The examination was administered to OBGYN residents, Female Pelvic Medicine and Reconstructive Surgery (FPMRS) fellows, practicing OBGYN physicians and FPMRS experts. Surgical judgment was evaluated by comparing scores against the experts. Factors related to surgical experience were measured for association with scores. RESULTS: In total, 147 participants including 11 residents, 37 fellows, 88 practicing physicians and 11 experts completed the 45-item examination. Mean scores for practicing physicians (65.2 ± 7.4) were similar to residents (67.2 ± 7.1), and worse than fellows (72.6 ± 4.2, p < 0.001) and experts (80 ± 5, p < 0.001). Positive correlations between scores and surgical experience included: annual number of vaginal hysterectomies (r = 0.32, p = <0.001), robotic hysterectomies (r = 0.17, p = 0.048), stress incontinence (r = 0.29, p < 0.001) and prolapse procedures (r = 0.37, p < 0.001). Inverse correlation was seen between test scores and years in practice. (r = -0.19, p = 0.02). CONCLUSION: Intraoperative judgment in practicing OBGYN physicians appears similar to resident physicians. Practicing physicians who perform FPMRS procedures perform poorly on this examination of surgical judgment; lower performance correlates with less surgical experience and the greater amount of time in practice.Item Open Access Assessing ureteral patency using 10% dextrose cystoscopy fluid: evaluation of urinary tract infection rates.(Am J Obstet Gynecol, 2016-07) Siff, Lauren N; Unger, Cecile A; Jelovsek, J Eric; Paraiso, Marie Fidela R; Ridgeway, Beri M; Barber, Matthew DBACKGROUND: Intravenous indigo carmine has routinely been used to confirm ureteral patency after urogynecologic surgery. Recent discontinuation of the dye has altered clinical practice. In the absence of indigo carmine, we have used 10% dextrose in sterile water (D10) as cystoscopic fluid to evaluate ureteral patency. Glucosuria has been associated with urinary tract infection (UTI) in vivo and significantly enhanced bacterial growth in vitro. The concern is that the use of D10 would mimic a state of glucosuria albeit transient and increase the risk of postoperative UTI. OBJECTIVES: The objectives of this study were to compare the rates of postoperative UTI and lower urinary tract (LUT) injuries between patients who underwent instillation of D10 vs normal saline at the time of intraoperative cystoscopy after urogynecological surgery. STUDY DESIGN: This was a retrospective cohort study of all women who underwent cystoscopic evaluation of ureteral patency at the time of urogynecological surgery from May through December 2014 at a tertiary care referral center. We compared patients who received D10 cystoscopy fluid vs those who used normal saline. Outcomes included UTI and diagnosis of ureteral or LUT injuries. UTI was diagnosed according to Centers for Disease Control and Prevention guidelines by symptoms alone, urine dipstick, urinalysis, or urine culture. Descriptive statistics compared the rates of UTI between the 2 groups, and a multivariable model was fit to the data to control for potential confounders and significant baseline differences between the groups. RESULTS: A total of 303 women were included. D10 was used in 113 cases and normal saline (NS) was used in 190. The rate of UTI was higher in the D10 group than the NS group: 47.8% (95% confidence interval [CI], 38.3-57.4) vs 25.9% (95% CI, 19.8-32.8, P < .001). After adjusting for age, pelvic organ prolapse stage, use of perioperative estrogen, days of postoperative catheterization, menopausal status, diabetes mellitus, and history of recurrent UTI, the UTI rate remained significantly higher with the use of D10 (adjusted odds ratio, 3.4 [95% CI, 1.6-7.5], P = .002) compared with NS. Overall, 3 cases of transient ureteral kinking (1.0%) and one cystotomy (0.3%) were identified intraoperatively. However, ureteral and LUT injuries were not different between groups. No unidentified injuries presented postoperatively. CONCLUSION: Although the use of D10 cystoscopy fluid has been successful in identifying ureteral patency in the absence of indigo carmine, it is associated with an increased rate of postoperative UTI compared with NS.Item Open Access Assessment of Long-Term Bowel Symptoms After Segmental Resection of Deeply Infiltrating Endometriosis: A Matched Cohort Study.(J Minim Invasive Gynecol, 2016-07) Soto, Enrique; Catenacci, Michelle; Bedient, Carrie; Jelovsek, J Eric; Falcone, TommasoSTUDY OBJECTIVE: To assess long-term bowel symptoms in women who underwent segmental bowel resection for deep-infiltrating endometriosis (DIE) compared with women who underwent resection of severe endometriosis without bowel resection. DESIGN: Cohort study with matched controls (Canadian Task Force classification II-2). SETTING: Cleveland Clinic. PATIENTS: 71 patients (36 cases and 35 controls). INTERVENTIONS: Patients who were at least 4 years out from undergoing segmental bowel resection due to DIE were matched with patients who had undergone resection of stage III/IV endometriosis without bowel resection. The patients completed validated questionnaires, and data were analyzed using the Wilcoxon rank-sum, χ(2), and Fisher exact tests. MEASUREMENTS AND MAIN RESULTS: The Bristol Stool Form Scale, Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM), and St Mark's Vaizey Fecal Incontinence Grading System were used to elicit information. The median duration of follow-up was 10.1 years (range, 4-18 years). The mean patient age and body mass index were comparable in the cases and the controls. A larger proportion of cases than controls reported new bowel symptoms (58% [21 of 36] vs 14% [5 of 35]; p = .001), as well as abdominal pain, incomplete bowel movements, and false alarms on the PAC-SYM questionnaire; however, total PAC-SYM and Vaizey Fecal Incontinence Grading System scores were similar in the 2 groups (median, 8 [interquartile range, 8-10] vs 8 [8-10]; p = .86). Similarly, the proportion of patients with normal stool consistency (Bristol Stool Form Scale score 2-6) was similar in the 2 groups (80.6% [29 of 36] vs 94.3% [33 of 35]; p = .59). CONCLUSION: Segmental bowel resection for DIE may be associated with a higher incidence of new bowel symptoms (possibly due to abdominal pain, incomplete bowel movements, and/or false alarms), but not with worse constipation or fecal incontinence, compared with surgery without bowel resection.Item Open Access Biofeedback or loperamide for faecal incontinence in women - Author's reply.(The lancet. Gastroenterology & hepatology, 2019-12) Jelovsek, J Eric; CAPABLe investigatorsItem Open Access Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial(The Lancet Gastroenterology & Hepatology, 2019-07) Jelovsek, J Eric; Markland, Alayne D; Whitehead, William E; Barber, Matthew D; Newman, Diane K; Rogers, Rebecca G; Dyer, Keisha; Visco, Anthony G; Sutkin, Gary; Zyczynski, Halina M; Carper, Benjamin; Meikle, Susan F; Sung, Vivian W; Gantz, Marie G; National Institute of Child Health and Human Development Pelvic Floor Disorders NetworkItem Open Access Development and Validation of a Model for Opioid Prescribing Following Gynecological Surgery.(JAMA network open, 2022-07) Rodriguez, Isabel V; Cisa, Paige McKeithan; Monuszko, Karen; Salinaro, Julia; Habib, Ashraf S; Jelovsek, J Eric; Havrilesky, Laura J; Davidson, BrittanyImportance
Overprescription of opioid medications following surgery is well documented. Current prescribing models have been proposed in narrow patient populations, which limits their generalizability.Objective
To develop and validate a model for predicting outpatient opioid use following a range of gynecological surgical procedures.Design, setting, and participants
In this prognostic study, statistical models were explored using data from a training cohort of participants undergoing gynecological surgery for benign and malignant indications enrolled prospectively at a single institution's academic gynecologic oncology practice from February 2018 to March 2019 (cohort 1) and considering 39 candidate predictors of opioid use. Final models were internally validated using a separate testing cohort enrolled from May 2019 to February 2020 (cohort 2). The best final model was updated by combining cohorts, and an online calculator was created. Data analysis was performed from March to May 2020.Exposures
Participants completed a preoperative survey and weekly postoperative assessments (up to 6 weeks) following gynecological surgery. Pain management was at the discretion of clinical practitioners.Main outcomes and measures
The response variable used in model development was number of pills used postoperatively, and the primary outcome was model performance using ordinal concordance and Brier score.Results
Data from 382 female adult participants (mean age, 56 years; range, 18-87 years) undergoing gynecological surgery (minimally invasive procedures, 158 patients [73%] in cohort 1 and 118 patients [71%] in cohort 2; open surgical procedures, 58 patients [27%] in cohort 1 and 48 patients [29%] in cohort 2) were included in model development. One hundred forty-seven patients (38%) used 0 pills after hospital discharge, and the mean (SD) number of pills used was 7 (10) (median [IQR], 3 [0-10] pills). The model used 7 predictors: age, educational attainment, smoking history, anticipated pain medication use, anxiety regarding surgery, operative time, and preoperative pregabalin administration. The ordinal concordance was 0.65 (95% CI, 0.62-0.68) for predicting 5 or more pills (Brier score, 0.22), 0.65 (95% CI, 0.62-0.68) for predicting 10 or more pills (Brier score, 0.18), and 0.65 (95% CI, 0.62-0.68) for predicting 15 or more pills (Brier score, 0.14).Conclusions and relevance
This model provides individualized estimates of outpatient opioid use following a range of gynecological surgical procedures for benign and malignant indications with all model inputs available at the time of procedure closing. Implementation of this model into the clinical setting is currently ongoing, with plans for additional validation in other surgical populations.Item Open Access Development and Validation of a Model for Predicting Surgical Site Infection After Pelvic Organ Prolapse Surgery.(Urogynecology (Hagerstown, Md.), 2022-10) Sheyn, David; Gregory, W Thomas; Osazuwa-Peters, Oyomoare; Jelovsek, J EricImportance
Surgical site infection (SSI) is a common and costly complication. Targeted interventions in high-risk patients may lead to a reduction in SSI; at present, there is no method to consistently identify patients at increased risk of SSI.Objective
The aim of this study was to develop and validate a model for predicting risk of SSI after pelvic organ prolapse surgery.Study design
Women undergoing surgery between 2011 and 2017 were identified using Current Procedural Terminology codes from the Centers for Medicare and Medicaid Services 5% Limited Data Set. Surgical site infection ≤90 days of surgery was the primary outcome, with 41 candidate predictors identified, including demographics, comorbidities, and perioperative variables. Generalized linear regression was used to fit a full specified model, including all predictors and a reduced penalized model approximating the full model. Model performance was measured using the c-statistic, Brier score, and calibration curves. Accuracy measures were internally validated using bootstrapping to correct for bias and overfitting. Decision curves were used to determine the net benefit of using the model.Results
Of 12,334 women, 4.7% experienced SSI. The approximated model included 10 predictors. Model accuracy was acceptable (bias-corrected c-statistic [95% confidence interval], 0.603 [0.578-0.624]; Brier score, 0.045). The model was moderately calibrated when predicting up to 5-6 times the average risk of SSI between 0 and 25-30%. There was a net benefit for clinical use when risk thresholds for intervention were between 3% and 12%.Conclusions
This model provides estimates of probability of SSI within 90 days after pelvic organ prolapse surgery and demonstrates net benefit when considering prevention strategies to reduce SSI.Item Open Access Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial.(JAMA, 2018-04) Jelovsek, J Eric; Barber, Matthew D; Brubaker, Linda; Norton, Peggy; Gantz, Marie; Richter, Holly E; Weidner, Alison; Menefee, Shawn; Schaffer, Joseph; Pugh, Norma; Meikle, Susan; NICHD Pelvic Floor Disorders NetworkUterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) are commonly performed pelvic organ prolapse procedures despite a lack of long-term efficacy data.To compare outcomes in women randomized to (1) ULS or SSLF and (2) usual care or perioperative behavioral therapy and pelvic floor muscle training (BPMT) for vaginal apical prolapse.This 2 × 2 factorial randomized clinical trial was conducted at 9 US medical centers. Eligible participants who completed the Operations and Pelvic Muscle Training in the Management of Apical Support Loss Trial enrolled between January 2008 and March 2011 and were followed up 5 years after their index surgery from April 2011 through June 2016.Two randomizations: (1) BPMT (n = 186) or usual care (n = 188) and (2) surgical intervention (ULS: n = 188 or SSLF: n = 186).The primary surgical outcome was time to surgical failure. Surgical failure was defined as (1) apical descent greater than one-third of total vaginal length or anterior or posterior vaginal wall beyond the hymen or retreatment for prolapse (anatomic failure), or (2) bothersome bulge symptoms. The primary behavioral outcomes were time to anatomic failure and Pelvic Organ Prolapse Distress Inventory scores (range, 0-300).The original study randomized 374 patients, of whom 309 were eligible for this extended trial. For this study, 285 enrolled (mean age, 57.2 years), of whom 244 (86%) completed the extended trial. By year 5, the estimated surgical failure rate was 61.5% in the ULS group and 70.3% in the SSLF group (adjusted difference, -8.8% [95% CI, -24.2 to 6.6]). The estimated anatomic failure rate was 45.6% in the BPMT group and 47.2% in the usual care group (adjusted difference, -1.6% [95% CI, -21.2 to 17.9]). Improvements in Pelvic Organ Prolapse Distress Inventory scores were -59.4 in the BPMT group and -61.8 in the usual care group (adjusted mean difference, 2.4 [95% CI, -13.7 to 18.4]).Among women who had undergone vaginal surgery for apical pelvic organ vaginal prolapse, there was no significant difference between ULS and SSLF in rates of surgical failure and no significant difference between perioperative behavioral muscle training and usual care on rates of anatomic success and symptom scores at 5 years. Compared with outcomes at 2 years, rates of surgical failure increased during the follow-up period, although prolapse symptom scores remained improved.clinicaltrials.gov Identifier: NCT01166373.Item Open Access Establishing cutoff scores on assessments of surgical skills to determine surgical competence.(Am J Obstet Gynecol, 2010-07) Jelovsek, J Eric; Walters, Mark D; Korn, Abner; Klingele, Christopher; Zite, Nikki; Ridgeway, Beri; Barber, Matthew DOBJECTIVE: The aim of this study was to establish minimum cutoff scores on intraoperative assessments of surgical skills to determine surgical competence for vaginal hysterectomy. STUDY DESIGN: Two surgical rating scales, the Global Rating Scale of Operative Performance and the Vaginal Surgical Skills Index, were used to evaluate trainees while performing vaginal hysterectomy. Cutoff scores were determined using the Modified Angoff method. RESULTS: Two hundred twelve evaluations were analyzed on 76 surgeries performed by 27 trainees. Trainees were considered minimally competent to perform vaginal hysterectomy if total absolute scores (95% confidence interval) on Global Rating Scale = 18 (16.5-20.3) and Vaginal Surgical Skills Index = 32 (27.7-35.5). On average, trainees met new cutoffs after performing 21 and 27 vaginal hysterectomies, respectively. With the new cutoffs applied to the same cohort of fourth-year obstetrics and gynecology trainees, all residents achieved competency in performing vaginal hysterectomy by the end of their gynecology rotations. CONCLUSION: Standard-setting methods using cutoff scores may be used to establish competence in vaginal surgery.Item Open Access Impact of treatment for Fecal Incontinence on Constipation Symptoms.(American journal of obstetrics and gynecology, 2019-11-22) Andy, Uduak U; Jelovsek, J Eric; Carper, Benjamin; Meyer, Isuzu; Dyer, Keisha Y; Rogers, Rebecca G; Mazloomdoost, Donna; Korbly, Nicole B; Sassani, Jessica C; Gantz, Marie G; Pelvic Floor Disorders NetworkOBJECTIVE:Defecatory symptoms, such as sense of incomplete emptying and straining with bowel movements, are paradoxically present in women with fecal incontinence (FI). Treatments for FI, such as loperamide and biofeedback, can worsen or improve defecatory symptoms, respectively. The primary aim of this study was to compare changes in constipation symptoms in women undergoing treatment for FI with education only, loperamide, anal muscle exercises with biofeedback, or both loperamide and biofeedback. Our secondary aim was to compare changes in constipation symptoms among responders and non-responders to FI treatment. METHODS:This was a planned secondary analysis of a randomized controlled trial comparing 2 first-line therapies for FI in a 2x2 factorial design. Women with at least monthly FI and normal stool consistency were randomized to 4 groups: 1) oral placebo plus education only, 2) oral loperamide plus education only, 3) placebo plus anorectal manometry-assisted biofeedback and 4) loperamide plus biofeedback. Defecatory symptoms were measured using the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at baseline, 12 weeks and 24 weeks. The PAC-SYM consists of 12 items that contribute to a global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps). Scores for each subscale as well as the global score range from 0 (no symptoms) to 4 (maximum score), with negative change scores representing improvement in defecatory symptoms. Responders to FI treatment were defined as women with a minimally important clinical improvement of ≥5-points on the St. Mark's (Vaizey) scale between baseline and 24 weeks. Intent-to-treat analysis was performed using a longitudinal mixed model, controlling for baseline scores, to estimate changes in PAC-SYM scores from baseline through 24 weeks. RESULTS:At 24 weeks, there were small changes in PAC-SYM global scores in all four groups: oral placebo plus education (-0.3; 95% CI -0.5, -0.1), loperamide plus education (-0.1, 95% CI -0.3, 0.0), oral placebo plus biofeedback (-0.3, 95% CI -0.4, -0.2), and loperamide plus biofeedback (-0.3, 95% CI -0.4, -0.2). No differences were observed in change in PAC-SYM scores between women randomized to placebo plus education and those randomized to loperamide plus education (p=0.17) or placebo plus biofeedback (p=0.82). Change in PAC-SYM scores in women randomized to combination loperamide plus biofeedback therapy was not different from that of women randomized to treatment with loperamide or biofeedback alone. Responders had greater improvement in PAC-SYM scores than non-responders (-0.4; 95% CI -0.5, -0.3 vs. -0.2; 95% CI -0.3, -0.0, p<0.01, mean difference 0.2, 95% CI 0.1, 0.4). CONCLUSION:Change in constipation symptoms following treatment of FI in women are small and are not significantly different between groups. Loperamide treatment for FI does not worsen constipation symptoms among women with normal consistency stool. Women with clinically significant improvement in FI symptoms report greater improvement in constipation symptoms.Item Open Access Incidence of adverse events after uterosacral colpopexy for uterovaginal and posthysterectomy vault prolapse.(Am J Obstet Gynecol, 2015-05) Unger, Cecile A; Walters, Mark D; Ridgeway, Beri; Jelovsek, J Eric; Barber, Matthew D; Paraiso, Marie Fidela ROBJECTIVE: We sought to describe perioperative and postoperative adverse events associated with uterosacral colpopexy, to describe the rate of recurrent pelvic organ prolapse (POP) associated with uterosacral colpopexy, and to determine whether surgeon technique and suture choice are associated with these rates. STUDY DESIGN: This was a retrospective chart review of women who underwent uterosacral colpopexy for POP from January 2006 through December 2011 at a single tertiary care center. The electronic medical record was queried for demographic, intraoperative, and postoperative data. Strict definitions were used for all clinically relevant adverse events. Recurrent POP was defined as the following: symptomatic vaginal bulge, prolapse to or beyond the hymen, or any retreatment for POP. RESULTS: In all, 983 subjects met study inclusion criteria. The overall adverse event rate was 31.2% (95% confidence interval [CI], 29.2-38.6), which included 20.3% (95% CI, 17.9-23.6) of subjects with postoperative urinary tract infections. Of all adverse events, 3.4% were attributed to a preexisting medical condition, while all other events were ascribed to the surgical intervention. Vaginal hysterectomy, age, and operative time were not significantly associated with any adverse event. The intraoperative bladder injury rate was 1% (95% CI, 0.6-1.9) and there were no intraoperative ureteral injuries; 4.5% (95% CI, 3.4-6.0) of cases were complicated by ureteral kinking requiring suture removal. The rates of pulmonary and cardiac complications were 2.3% (95% CI, 1.6-3.5) and 0.8% (95% CI, 0.4-1.6); and the rates of postoperative ileus and small bowel obstruction were 0.1% (95% CI, 0.02-0.6) and 0.8% (95% CI, 0.4-1.6). The composite recurrent POP rate was 14.4% (95% CI, 12.4-16.8): 10.6% (95% CI, 8.8-12.7) of patients experienced vaginal bulge symptoms, 11% (95% CI, 9.2-13.1) presented with prolapse to or beyond the hymen, and 3.4% (95% CI, 2.4-4.7) required retreatment. Number and type of suture used were not associated with a higher rate of recurrence. Of the subjects who required unilateral removal of sutures to resolve ureteral kinking, 63.6% did not undergo suture replacement; this was not associated with a higher rate of POP recurrence. CONCLUSION: Perioperative and postoperative complication rates associated with severe morbidity after uterosacral colpopexy appear to be low. Uterosacral colpopexy remains a safe option for the treatment of vaginal vault prolapse.Item Open Access Incidence of lower urinary tract injury at the time of total laparoscopic hysterectomy.(JSLS, 2007-10) Jelovsek, J Eric; Chiung, Chi; Chen, Grace; Roberts, Soldrea L; Paraiso, Marie Fidela R; Falcone, TommasoOBJECTIVES: To determine the incidence of and risk factors for injury to the lower urinary tract during total laparoscopic hysterectomy. METHODS: All patients who underwent total laparoscopic hysterectomy for benign disease from January 1, 2002 to December 31, 2005, at an academic medical center are included. Subjects undergoing laparoscopic-assisted vaginal hysterectomy, supracervical hysterectomy, or hysterectomy for malignancy were excluded. Intraoperative cystoscopy with intravenous indigo carmine was routinely performed. Relevant data were abstracted to determine the incidence of lower urinary tract injury, predictors of injury, and postoperative complications. RESULTS: Total laparoscopic hysterectomy was performed in 126 consecutive subjects. Two (1.6%) cystotomies were noted and repaired before cystoscopy was performed. Two (1.6%) additional cystotomies were detected during cystoscopy. Absent ureteral spill of indigo carmine was detected in 2 subjects: 1 (0.8%) with previously unknown renal disease and 1 (0.8%) with ureteral obstruction that was relieved with subsequent suture removal. Only 40% (2/5) of injuries were recognized without the use of cystoscopy with indigo carmine. The overall incidence of injury to the lower urinary tract was 4.0%. No subjects required postoperative intervention to the lower urinary tract within the 6-week perioperative period. Performing a ureterolysis was associated with an increased rate (odds ratio 8.7, 95%CI, 1.2-170, P=0.024) of lower urinary tract injury. CONCLUSION: Surgeons should consider performing cystoscopy with intravenous indigo carmine dye at the time of total laparoscopic hysterectomy.Item Open Access Incorporating simulation into gynecologic surgical training(American Journal of Obstetrics and Gynecology, 2017-01-01) Wohlrab, Kyle; Jelovsek, J Eric; Myers, DeborahToday's educational environment has made it more difficult to rely on the Halstedian model of "see one, do one, teach one" in gynecologic surgical training. There is decreased surgical volume, but an increased number of surgical modalities. Fortunately, surgical simulation has evolved to fill the educational void. Whether it is through skill generalization or skill transfer, surgical simulation has shifted learning from the operating room back to the classroom. This article explores the principles of surgical education and ways to introduce simulation as an adjunct to residency training. We review high- and low-fidelity surgical simulators, discuss the progression of surgical skills, and provide options for skills competency assessment. Time and money are major hurdles when designing a simulation curriculum, but low-fidelity models, intradepartmental cost sharing, and utilizing local experts for simulation proctoring can aid in developing a simulation program.Item Open Access Irritable Bowel Syndrome and Quality of Life in Women With Fecal Incontinence.(Female Pelvic Med Reconstr Surg, 2017-08-01) Markland, Alayne D; Jelovsek, J Eric; Rahn, David D; Wang, Lu; Merrin, Leah; Tuteja, Ashok; Richter, Holly E; Meikle, Susan; Pelvic Floor Disorders NetworkOBJECTIVES: The objectives of this work were to determine the prevalence of irritable bowel syndrome (IBS) and IBS subtypes in women presenting for fecal incontinence (FI) treatment and to assess the impact of IBS on FI symptoms and quality of life (QOL). METHODS: In this multicenter prospective cohort study, women reported at least monthly solid, liquid, or mucus FI. Rome III clinical criteria defined IBS. Women also self-reported having an IBS diagnosis. Baseline questionnaires included the following: Modified Manchester Health Questionnaire, Fecal Incontinence Severity Index, Bristol Stool Scale, Pelvic Floor Distress Inventory, and the Pelvic Floor Impact Questionnaire. RESULTS: Of the 133 women enrolled, 119 completed Rome III IBS questionnaires, and 111 reported on whether they had a previous diagnosis of IBS. The prevalence of IBS was 31% (95% confidence interval [CI], 22.9%-40.2%) according to the Rome III IBS criteria. The most common subtypes were IBS-mixed (41%) and IBS-diarrhea (35%). Twenty-four (22%) of 111 patients had a previous diagnosis of IBS. Among women who met Rome III IBS criteria, 23 (66%) of 35 women had never had a diagnosis of IBS. Women with FI and IBS reported significantly worse QOL compared to women without IBS despite similar FI severity and stool consistency. CONCLUSIONS: Irritable bowel syndrome negatively affects QOL and affects one third of women with FI presenting for care in tertiary centers. Our findings suggest that assessment of IBS symptoms and diagnosis may be important for women presenting for FI treatment.Item Open Access Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial.(Obstet Gynecol, 2011-11) Paraiso, Marie Fidela R; Jelovsek, J Eric; Frick, Anna; Chen, Chi Chung Grace; Barber, Matthew DOBJECTIVE: To compare conventional laparoscopic and robotic-assisted laparoscopic sacrocolpopexy for vaginal apex prolapse. METHODS: This single-center, blinded randomized trial included participants with stage 2-4 posthysterectomy vaginal prolapse. Participants were randomized to laparoscopic or robotic sacrocolpopexy. The primary outcome was total operative time from incision to closure. Secondary outcomes were postoperative pain, functional activity, bowel and bladder symptoms, quality of life, anatomic vaginal support, and cost from a health care system perspective. RESULTS: A total of 78 patients enrolled and were randomized (laparoscopic n=38; robotic n=40). Total operative time was significantly longer in the robotic group compared with the laparoscopic group (+67-minute difference; 95% confidence interval [CI] 43-89; P<.001). Anesthesia time, total time in the operating room, total sacrocolpopexy time, and total suturing time were all significantly longer in the robotic group. Participants in the robotic group also had significantly higher pain at rest and with activity during weeks 3 through 5 after surgery and required longer use of nonsteroidal anti-inflammatory drugs (median, 20 compared with 11 days, P<.005). The robotic group incurred greater cost than the laparoscopic group (mean difference +$1,936; 95% CI $417-$3,454; P=.008). Both groups demonstrated significant improvement in vaginal support and functional outcomes 1 year after surgery with no differences between groups. CONCLUSION: Robotic-assisted sacrocolpopexy results in longer operating time and increased pain and cost compared with the conventional laparoscopic approach.Item Open Access Long-Term Effectiveness of Uterosacral Colpopexy and Minimally Invasive Sacral Colpopexy for Treatment of Pelvic Organ Prolapse.(Female Pelvic Med Reconstr Surg, 2017-08-01) Unger, Cecile A; Barber, Matthew D; Walters, Mark D; Paraiso, Marie Fidela R; Ridgeway, Beri; Jelovsek, J EricOBJECTIVES: The objective of this study was to estimate rates of recurrent pelvic organ prolapse (POP) 6 years after patients underwent transvaginal uterosacral colpopexy, or laparoscopic or robotic sacral colpopexy at a large tertiary care center. We hypothesized that recurrence rates would be higher than those previously reported. METHODS: This is a retrospective study of women who underwent uterosacral colpopexy, laparoscopic, and robotic sacral colpopexy for treatment of POP between 2006 and 2012. A composite outcome for recurrent POP was defined as subjective failure (vaginal bulge symptoms), objective failure (prolapse to or beyond the hymen), or any retreatment for POP (reoperation or use of a pessary). Kaplan-Meier survival curves were generated from each patient's date of follow-up, and parametric survival modeling was used to estimate recurrent POP over 6 years. Annual estimated recurrence rates by type of colpopexy are reported using the composite and individual definitions for recurrent POP. RESULTS: One thousand three hundred eighty-one subjects met inclusion criteria: 983 (71.1 %) uterosacral, 256 (18.5%) laparoscopic, and 142 (11.2%) robotic colpopexies. Median (range) months to failure using composite recurrence were as follows: uterosacral, 17.1 (7.6-41); laparoscopic, 10.1 (4.7-25.1); robotic, 9.7 (1.6-17.2). By year 6 in the model, the estimated composite recurrence rates for the uterosacral colpopexy, robotic, and laparoscopic sacral colpopexy groups were 43%, 49%, and 57%, respectively. CONCLUSIONS: Estimated recurrence rates for uterosacral ligament colpopexy, laparoscopic, and robotic sacral colpopexy may be as high as 40% to 60% 6 years after surgery.Item Open Access Measuring surgical trainee perceptions to assess the operating room educational environment.(J Surg Educ, 2010-07) Diwadkar, Gouri B; Jelovsek, J EricOBJECTIVE: To determine measurable differences in the perception of learning between junior and senior residents in the operating rooms of an obstetrics and gynecology (OBGYN) residency program. DESIGN, SETTING, AND PARTICIPANTS: Using a cross-sectional design, the Operating Room Educational Environment Measure (OREEM), a 40-item educational environment inventory, was administered to 28 OBGYN residents from 1 training program, who train at 3 hospital sites. The OREEM measures a trainee's perceptions of the teaching surgeon, learning opportunities, operating room atmosphere, and workload. The primary outcome was total OREEM scores and secondary outcomes were OREEM subscale scores, global impression of education, and internal consistency and validity of the OREEM scale. Group sample sizes of 10 and 10 achieved 80% power to detect a 10% difference between group mean OREEM scores +/- 10% with a significance level of 0.05. RESULTS: Twenty-four residents including 11 junior (postgraduate years 1 and 2) and 13 senior (postgraduate years 3 and 4) residents were included in the analysis. Total OREEM scores, learning opportunities, and workload/support subscale scores were significantly lower for junior residents compared with senior residents across all sites. Perceptions of learning at a multispecialty tertiary referral hospital were lower than the community and regional hospitals. This was secondary to complexity of cases, subspecialty fellows, and decreased opportunities to first-assist in the operating room. The OREEM demonstrated acceptable reliability and construct validity. CONCLUSIONS: There are measurable differences in perception of the operating room educational environment between junior and senior OBGYN residents using the reliable and valid Operating Room Educational Environment Measure.