Beri Ridgeway

Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse

IMPORTANCE More than 225 000 surgeries are performed annually in the United States for pelvic organ prolapse (POP). Abdominal sacrocolpopexy is considered the most durable POP surgery, but little is known about safety and long-term effectiveness. OBJECTIVES To describe anatomic and symptomatic outcomes up to 7 years after abdominal sacrocolpopexy, and to determine whether these are affected by concomitant anti-incontinence surgery (Burch urethropexy). DESIGN, SETTING, AND PARTICIPANTS Long-term follow-up of the randomized, masked 2-year Colpopexy and Urinary Reduction Efforts (CARE) trial of women with stress continence who underwent abdominal sacrocolpopexy between 2002 and 2005 for symptomatic POP and also received either concomitant Burch urethropexy or no urethropexy. Ninety-two percent (215/233) of eligible 2-year CARE trial completers were enrolled in the extended CARE study; and 181 (84%) and 126 (59%) completed 5 and 7 years of follow-up, respectively. The median follow-up was 7 years. MAIN OUTCOMES AND MEASURES Symptomatic POP failure requiring retreatment or self-reported bulge; or anatomic POP failure requiring retreatment or Pelvic Organ Prolapse Quantification evaluation demonstrating descent of the vaginal apex below the upper third of the vagina, or anterior or posterior vaginal wall prolapse beyond the hymen. Stress urinary incontinence (SUI) with more than 1 symptom or interval treatment; or overall UI score of 3 or greater on the Incontinence Severity Index. RESULTS By year 7, the estimated probabilities of treatment failure (POP, SUI, UI) from parametric survival modeling for the urethropexy group and the no urethropexy group, respectively, were 0.27 and 0.22 for anatomic POP (treatment difference of 0.050; 95% CI, -0.161 to 0.271), 0.29 and 0.24 for symptomatic POP (treatment difference of 0.049; 95% CI, -0.060 to 0.162), 0.48 and 0.34 for composite POP (treatment difference of 0.134; 95% CI, -0.096 to 0.322), 0.62 and 0.77 for SUI (treatment difference of -0.153; 95% CI, -0.268 to 0.030), and 0.75 and 0.81 for overall UI (treatment difference of -0.064; 95% CI, -0.161 to 0.032). Mesh erosion probability at 7 years (estimated by the Kaplan-Meier method) was 10.5% (95% CI, 6.8% to 16.1%). CONCLUSIONS AND RELEVANCE During 7 years of follow-up, abdominal sacrocolpopexy failure rates increased in both groups. Urethropexy prevented SUI longer than no urethropexy. Abdominal sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00099372.

Biologic grafts and synthetic meshes in pelvic reconstructive surgery.

Despite the lack of evidence, augmenting pelvic organ prolapse surgery with biologic graft or synthetic mesh is increasing. The objective of this review is to examine the available grafts and meshes and discuss the current data addressing the use of these implants in correction of apical, anterior, and posterior prolapse. Most of the studies are retrospective with few randomized controlled trials. There is level I evidence suggesting that repair of apical prolapse with abdominal sacral colpopexy using synthetic mesh results in improved outcomes. However, most of the data concerning graft or mesh incorporation in anterior or posterior repairs do not support augmentation with prosthesis.

A randomized trial comparing conventional and robotically assisted total laparoscopic hysterectomy

OBJECTIVE The purpose of this study was to compare operative time and intra- and postoperative complications between total laparoscopic hysterectomy and robotic-assisted total laparoscopic hysterectomy. STUDY DESIGN This study was a blinded, prospective randomized controlled trial conducted at 2 institutions. Subjects consisted of women who planned laparoscopic hysterectomy for benign indications. Preoperative randomization to total laparoscopic hysterectomy or robotic-assisted total laparoscopic hysterectomy was stratified by surgeon and uterine size (> or ≤12 weeks). Validated questionnaires, activity assessment scales, and visual analogue scales were administered at baseline and during follow-up evaluation. RESULTS Sixty-two women gave consent and were enrolled and randomly assigned; 53 women underwent surgery (laparoscopic, 27 women; robot-assisted, 26 women). There were no demographic differences between groups. Compared with laparoscopic hysterectomy, total case time (skin incision to skin closure) was significantly longer in the robot-assisted group (mean difference, +77 minutes; 95% confidence interval, 33-121; P < .001] as was total operating room time (entry into operating room to exit; mean difference, +72 minutes; 95% confidence interval, 14-130; P = .016). Mean docking time was 6 ± 4 minutes. There were no significant differences between groups in estimated blood loss, pre- and postoperative hematocrit change, and length of stay. There were very few complications, with no difference in individual complication types or total complications between groups. Postoperative pain and return to daily activities were no different between groups. CONCLUSION Although laparoscopic and robotic-assisted hysterectomies are safe approaches to hysterectomy, robotic-assisted hysterectomy requires a significantly longer operative time.

A new measure of sexual function in women with pelvic floor disorders (PFD): the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)

Introduction and hypothesisThe objective of this study was to create a valid, reliable, and responsive sexual function measure in women with pelvic floor disorders (PFDs) for both sexually active (SA) and inactive (NSA) women.MethodsExpert review identified concept gaps and generated items evaluated with cognitive interviews. Women underwent Pelvic Organ Prolapse Quantification (POPQ) exams and completed the Incontinence Severity Index (ISI), a prolapse question from the Epidemiology of Prolapse and Incontinence Questionnaire (ISI scores), the Pelvic Floor Distress Inventory-20 (PFDI-20), and the Female Sexual Function Index (FSFI). Principle components and orthogonal varimax rotation and principle factor analysis with oblique rotation identified item grouping. Cronbach’s alpha measured internal consistency. Factor correlations evaluated criterion validation. Change scores compared to change scores in other measures evaluated responsiveness among women who underwent surgery.ResultsA total of 589 women gave baseline data, 200 returned surveys after treatment, and 147 provided test-retest data. For SA women, 3 subscales each in 2 domains (21 items) and for NSA women 2 subscales in each of 2 domains (12 items) emerged with robust psychometric properties. Cronbach’s alpha ranged from .63 to .91. For SA women, correlations were in the anticipated direction with PFDI-20, ISI, and FSFI scores, POPQ, and EPIQ question #35 (all p < .05). PFDI-20, ISI, and FSFI subscale change scores correlated with Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire International Urogynecological Association-revised (PISQ-IR) factor change scores and with mean change scores in women who underwent surgery (all p < .05). For NSA women, PISQ-IR scores correlated with PFDI-20, ISI scores, and with EPIQ question #35 (all p < .05). No items demonstrated differences between test and retest (all p ≥ .05), indicating stability over time.ConclusionsThe PISQ-IR is a valid, reliable, and responsive measure of sexual function.

Early experience with mesh excision for adverse outcomes after transvaginal mesh placement using prolapse kits

OBJECTIVE The purpose of this study was to determine the complications, treatments, and outcomes in patients choosing to undergo removal of mesh previously placed with a mesh procedural kit. STUDY DESIGN This was a retrospective review of all patients who underwent surgical removal of transvaginal mesh for mesh-related complications during a 3-year period at Cleveland Clinic. At last follow-up, patients reported degree of pain, level of improvement, sexual activity, and continued symptoms. RESULTS Nineteen patients underwent removal of mesh during the study period. Indications for removal included chronic pain (6/19), dyspareunia (6/19), recurrent pelvic organ prolapse (8/19), mesh erosion (12/19), and vesicovaginal fistula (3/19), with most patients (16/19) citing more than 1 reason. There were few complications related to the mesh removal. Most patients reported significant relief of symptoms. CONCLUSION Mesh removal can be technically difficult but appears to be safe with few complications and high relief of symptoms, although some symptoms can persist.

Attitudes toward hysterectomy in women undergoing evaluation for uterovaginal prolapse.

Objectives To investigate attitudes toward hysterectomy in women seeking care for pelvic organ prolapse. Methods Two hundred twenty women referred for evaluation of prolapse without evidence of previous hysterectomy were surveyed with the Pelvic Organ Prolapse Distress Inventory; the Control Preferences Scale; and questions regarding patients’ perception of the impact of hysterectomy on health, social life, and emotional well-being. Additional items presented hypothetical scenarios. Surveys were distributed in small batches until 100 responses were obtained from patients who met inclusion criteria. Results One hundred women with an intact uterus responded. Sixty percent indicated they would decline hysterectomy if presented with an equally efficacious alternative to a hysterectomy-based prolapse repair. The doctor’s opinion, risk of surgical complications, and risk of malignancy were the most important factors in surgical decision making. Conclusions Many women with prolapse prefer to retain their uterus at the time of surgery in the absence of a substantial benefit to hysterectomy. These findings should provide further impetus to investigate the efficacy of uterine-sparing procedures to help women make informed decisions regarding prolapse surgery.

Perioperative adverse events after minimally invasive abdominal sacrocolpopexy

OBJECTIVE Our first objective was to compare peri- and postoperative adverse events between robotic-assisted laparoscopic sacrocolpopexy (RSC) and conventional laparoscopic sacrocolpopexy (LSC) in a cohort of women who underwent these procedures at a tertiary care center. Our second objective was to explore whether hysterectomy and rectopexy at the time of sacrocolpopexy were associated with these adverse events. STUDY DESIGN This was a retrospective cohort study of women who underwent either RSC or LSC with or without concomitant hysterectomy and/or rectopexy from 2006-2012. Once patients were identified as either having undergone RSC or LSC, the electronic medical record was queried for demographic, peri-, and postoperative data. RESULTS Four hundred six women met study inclusion criteria. Mean age and body mass index of all the women were 58 ± 10 years and 27.9 ± 4.9 kg/m(2). The women who underwent RSC were older (60 ± 9 vs 57 ± 10 years, respectively; P = .009) and more likely to be postmenopausal (90.9% vs 79.1%, respectively; P = .05). RSC cases were associated with a higher intraoperative bladder injury rate (3.3% vs 0.4%, respectively; P = .04), a higher rate of estimated blood loss of ≥500 mL (2.5% vs 0, respectively; P = .01), and reoperation rate for pelvic organ prolapse (4.9% vs 1.1%, respectively; P = .02) compared with LSC. Concomitant rectopexy was associated with a higher risk of transfusion (2.8% vs 0.3%, respectively; P = .04), pelvic/abdominal abscess formation (11.1% vs 0.8%, respectively; P < .001), and osteomyelitis (5.6% vs 0, respectively; P < .001). The mesh erosion rate for all the women was 2.7% and was not statistically different between LSC and RSC and for patients who underwent concomitant hysterectomy and those who did not. CONCLUSION Peri- and postoperative outcomes after RSC and LSC are favorable, with few adverse outcomes. RSC is associated with a higher rate of bladder injury, estimated blood loss ≥500 mL, and reoperation for recurrent pelvic organ prolapse; otherwise, the rate of adverse events is similar between the 2 modalities. Concomitant rectopexy is associated with a higher rate of postoperative abscess and osteomyelitis complications.

The use of synthetic mesh in pelvic reconstructive surgery

The use of synthetic materials in pelvic reconstructive surgery is increasing. Abdominal sacral colpopexy with permanent, type I mesh is a durable and safe operation to treat apical prolapse. The incorporation of synthetic materials during surgery to correct anterior and posterior prolapse has variable anatomic results, with several studies demonstrating moderate rates of mesh-related complications. Procedural kits for vaginal placement of synthetic materials are becoming popular, though long-term outcome and safety data are lacking.

Establishing cutoff scores on assessments of surgical skills to determine surgical competence

OBJECTIVE 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.

Pyogenic spondylodiscitis associated with sacral colpopexy and rectopexy: report of two cases and evaluation of the literature

Pyogenic spondylodiscitis includes a spectrum of spinal infections such as discitis, osteomyelitis, epidural abscess, meningitis, subdural empyema, and spinal cord abscess. This is a rare complication of sacral colpopexy, but can lead to devastating consequences for the patient. We present two cases of pyogenic spondylodiscitis following sacral colpopexy. In addition, we discuss 26 cases of pyogenic spondylodiscitis reported in the literature from 1957 to 2012. Techniques to decrease rates of infection include proper identification of the S1 vertebra, awareness of the suture placement depth at the level of the sacrum and at the vagina, and early treatment of post-operative urinary tract and vaginal infections. Awareness of symptoms, timely diagnosis and multidisciplinary approach to management is essential in preventing long-term complications.