Browsing by Author "Ridgeway, Beri"
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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 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 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 Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial.(Int Urogynecol J, 2016-10) Sung, Vivian W; Borello-France, Diane; Dunivan, Gena; Gantz, Marie; Lukacz, Emily S; Moalli, Pamela; Newman, Diane K; Richter, Holly E; Ridgeway, Beri; Smith, Ariana L; Weidner, Alison C; Meikle, Susan; Pelvic Floor Disorders NetworkINTRODUCTION AND HYPOTHESIS: Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. METHODS: ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment. RESULTS: The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized. CONCLUSIONS: We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.