Enabling Technologies for Gynecologic Vaginal Surgery: A Systematic Review.

OBJECTIVE: To systematically review the literature to evaluate clinical and surgical outcomes for technologies that facilitate vaginal surgical procedures. DATA SOURCES: We systematically searched MEDLINE, EMBASE, and ClinicalTrials.gov from January 1990 to May 2022. METHODS OF STUDY SELECTION: Comparative and single-arm studies with data on contemporary tools or technologies facilitating intraoperative performance of vaginal gynecologic surgical procedures for benign indications were included. Citations were independently double screened, and eligible full-text articles were extracted by two reviewers. Data collected included study characteristics, technology, patient demographics, and intraoperative and postoperative outcomes. Risk of bias for comparative studies was assessed using established methods, and restricted maximum likelihood model meta-analyses were conducted as indicated. TABULATION, INTEGRATION, AND RESULTS: The search yielded 8,658 abstracts, with 116 eligible studies that evaluated pedicle sealing devices (n=32), nonrobotic and robotic vaginal natural orifice transluminal endoscopic surgery (n=64), suture capture devices (n=17), loop ligatures (n=2), and table-mounted telescopic cameras (n=1). Based on 19 comparative studies, pedicle sealing devices lowered vaginal hysterectomy operative time by 15.9 minutes (95% CI, -23.3 to -85), blood loss by 36.9 mL (95% CI, -56.9 to -17.0), hospital stay by 0.2 days (95% CI, -0.4 to -0.1), and visual analog scale pain scores by 1.4 points on a subjective 10-point scale (95% CI, -1.7 to -1.1). Three nonrandomized comparative studies and 53 single-arm studies supported the feasibility of nonrobotic vaginal natural orifice transluminal endoscopic surgery for hysterectomy, adnexal surgery, pelvic reconstruction, and myomectomy. Data were limited for robotic vaginal natural orifice transluminal endoscopic surgery, suture capture devices, loop ligatures, and table-mounted cameras due to few studies or study heterogeneity. CONCLUSION: Pedicle sealing devices lower operative time and blood loss for vaginal hysterectomy, with modest reductions in hospital stay and pain scores. Although other technologies identified in the literature may have potential to facilitate vaginal surgical procedures and improve outcomes, additional comparative effectiveness research is needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42022327490.

Repair of Vesicovaginal Fistulae: A Systematic Review.

OBJECTIVE: To assess and compile the current level of evidence regarding successful surgical treatment of vesicovaginal fistulae and how these perioperative interventions affect anatomic, patient-centered, and adverse outcomes. DATA SOURCES: PubMed and EMBASE were searched from inception through September 9, 2022. METHODS OF STUDY SELECTION: This review included comparative studies (of any sample size) and single-group studies (1,000 or more participants) of primary or recurrent vesicovaginal fistula (ie, vesicovaginal fistula, urethrovaginal fistula, and bladder neck-vaginal fistula). We evaluated preintervention assessment or management, various techniques for intraoperative management, and postoperative management. Outcomes of interest included anatomic and objective outcomes (such as successful repair, fistula closure, urinary incontinence, recurrent fistula, perioperative complications) and subjective outcomes (such as voiding symptoms and quality of life). Abstracts and full-text articles were screened in duplicate, and study descriptions and findings were extracted into standardized extraction forms. Risk of bias was assessed independently by two investigators and adjudicated by a third. Study quality was summarized with standardized tools. We conducted random-effects model and restricted maximum-likelihood meta-analyses of relative risks when at least three studies compared similar interventions and reported similar outcome measures. TABULATION, INTEGRATION, AND RESULTS: Forty-six studies met the inclusion criteria. Studies were categorized into 11 domains: 1) preoperative assessment, 2) preoperative and postoperative physical therapy, 3) route of surgery, 4) incorporation of a flap, 5) trimming, 6) layered closure, 7) intraoperative antibiotics, 8) fibrin glue, 9) fascial sling, 10) postoperative Foley catheter duration, and 11) quality of life. Although the strength of the data is insufficient, preoperative phenazopyridine, physical therapy, layered closure, and intraoperative antibiotics seemed to improve the rate of successful fistula repair. Route of surgery (vaginal vs abdominal laparotomy) was determined primarily by surgeon preference and showed no difference in successful fistula repair. In addition, use of interpositional flaps, trimming fistula edges, fibrin glue, and fascial sling did not show significant improvement in rates of fistula cure. Overall, quality-of-life scores improved postoperatively regardless of route of repair and use of interpositional flaps. CONCLUSION: Our findings highlight the limited information available to guide evidence-based treatment of vesicovaginal fistula repair. Overall, high-quality evidence is lacking to provide guidelines; therefore, expert opinion remains the primary influence for fistula repair recommendations. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021214948.

Nonestrogen Therapies for Treatment of Genitourinary Syndrome of Menopause: A Systematic Review.

OBJECTIVE: To systematically review the literature and provide clinical practice guidelines regarding various nonestrogen therapies for treatment of genitourinary syndrome of menopause (GSM). DATA SOURCES: MEDLINE, EMBASE, ClinicalTrials.gov , and Cochrane databases were searched from inception to July 2021. We included comparative and noncomparative studies. Interventions and comparators were limited to seven products that are commercially available and currently in use (vaginal dehydroepiandrosterone [DHEA], ospemifene, laser or energy-based therapies, polycarbophil-based vaginal moisturizer, Tibolone, vaginal hyaluronic acid, testosterone). Topical estrogen, placebo, other nonestrogen products, as well as no treatment were considered as comparators. METHODS OF STUDY SELECTION: We double-screened 9,131 abstracts and identified 136 studies that met our criteria. Studies were assessed for quality and strength of evidence by the systematic review group. TABULATION, INTEGRATION, AND RESULTS: Information regarding the participants, details on the intervention and comparator and outcomes were extracted from the eligible studies. Alternative therapies were similar or superior to estrogen or placebo with minimal increase in adverse events. Dose response was noted with vaginal DHEA and testosterone. Vaginal DHEA, ospemifene, erbium and fractional carbon dioxide (CO 2 ) laser, polycarbophil-based vaginal moisturizer, tibolone, hyaluronic acid, and testosterone all improved subjective and objective signs of atrophy. Vaginal DHEA, ospemifene, tibolone, fractional CO 2 laser, polycarbophil-based vaginal moisturizer, and testosterone improved sexual function. CONCLUSION: Most nonestrogen therapies are effective treatments for the various symptoms of GSM. There are insufficient data to compare nonestrogen options to each other.

Changes in Pelvic Floor Symptoms After Procedural Interventions for Uterine Leiomyomas: A Systematic Review.

OBJECTIVE: To conduct a systematic review to evaluate the effect of procedural interventions for leiomyomas on pelvic floor symptoms. DATA SOURCES: PubMed, EMBASE, and ClinicalTrials.gov were searched from inception to January 12, 2023, searching for leiomyoma procedures and pelvic floor disorders and symptoms, restricted to primary study designs in humans. METHODS OF STUDY SELECTION: Double independent screening for studies of any study design in all languages that reported pelvic floor symptoms before and after surgical (hysterectomy, myomectomy, radiofrequency volumetric thermal ablation) or radiologic (uterine artery embolization, magnetic resonance-guided focused ultrasonography, high-intensity focused ultrasonography) procedures for management of uterine leiomyomas. Data were extracted, with risk-of-bias assessment and review by a second researcher. Random effects model meta-analyses were conducted, as feasible. TABULATION, INTEGRATION, AND RESULTS: Six randomized controlled trials, one nonrandomized comparative study, and 25 single-group studies met criteria. The overall quality of the studies was moderate. Only six studies, reporting various outcomes, directly compared two procedures for leiomyomas. Across studies, leiomyoma procedures were associated with decreased symptom distress per the UDI-6 (Urinary Distress Inventory, Short Form) (summary mean change -18.7, 95% CI -25.9 to -11.5; six studies) and improved quality of life per the IIQ-7 (Incontinence Impact Questionnaire, Short Form) (summary mean change -10.7, 95% CI -15.8 to -5.6; six studies). There was a wide range of resolution of urinary symptoms after procedural interventions (7.6-100%), and this varied over time. Urinary symptoms improved in 19.0-87.5% of patients, and the definitions for improvement varied between studies. Bowel symptoms were inconsistently reported in the literature. CONCLUSION: Urinary symptoms improved after procedural interventions for uterine leiomyomas, although there is high heterogeneity among studies and few data on long-term outcomes or comparing different procedures. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021272678.

Adherence to Perioperative Behavioral Therapy With Pelvic Floor Muscle Training in Women Receiving Vaginal Reconstructive Surgery for Pelvic Organ Prolapse.

OBJECTIVE: The objective of this study was to describe adherence to behavioral and pelvic floor muscle training in women undergoing vaginal reconstructive surgery for organ prolapse and to examine whether adherence was associated with 24-month outcomes. METHODS: Participants were women ≥18 years of age, with vaginal bulge and stress urinary incontinence symptoms, planning to undergo vaginal reconstructive surgery for stages 2 to 4 vaginal or uterine prolapse. They were randomized to either sacrospinous ligament fixation or uterosacral ligament suspension and to perioperative behavioral and pelvic floor muscle training or usual care. Measurements included anatomic failure, pelvic floor muscle strength, participant-reported symptoms, and perceived improvement. Analyses compared women with lower versus higher adherence. RESULTS: Forty-eight percent of women performed pelvic floor muscle exercises (PFMEs) daily at the 4- to 6-week visit. Only 33% performed the prescribed number of muscle contractions. At 8 weeks, 37% performed PFMEs daily, and 28% performed the prescribed number of contractions. No significant relationships were found between adherence and 24-month outcomes. CONCLUSION: Adherence to a behavioral intervention was low following vaginal reconstructive surgery for pelvic organ prolapse. The degree of adherence to perioperative training did not appear to influence 24-month outcomes in women undergoing vaginal prolapse surgery. IMPACT: This study contributes to the understanding of participant adherence to PFMEs and the impact that participant adherence has on outcomes at 2, 4 to 6, 8, and 12 weeks and 24 months postoperatively. It is important to educate women to follow up with their therapist or physician to report new or unresolved pelvic symptoms.

Prescription Opioid Use for Acute Pain and Persistent Opioid Use After Gynecologic Surgery: A Systematic Review.

OBJECTIVE: To assess the amount of opioid medication used by patients and the prevalence of persistent opioid use after discharge for gynecologic surgery for benign indications. DATA SOURCES: We systematically searched MEDLINE, EMBASE, and ClinicalTrials.gov from inception to October 2020. METHODS OF STUDY SELECTION: Studies with data on gynecologic surgical procedures for benign indications and the amount of outpatient opioids consumed, or the incidence of either persistent opioid use or opioid-use disorder postsurgery were included. Two reviewers independently screened citations and extracted data from eligible studies. TABULATION, INTEGRATION, AND RESULTS: Thirty-six studies (37 articles) met inclusion criteria. Data were extracted from 35 studies; 23 studies included data on opioids consumed after hospital discharge, and 12 studies included data on persistent opioid use after gynecologic surgery. Average morphine milligram equivalents (MME) used in the 14 days after discharge were 54.0 (95% CI 39.9-68.0, seven tablets of 5-mg oxycodone) across all gynecologic surgery types, 35.0 (95% CI 0-75.12, 4.5 tablets of 5-mg oxycodone) after a vaginal hysterectomy, 59.5 (95% CI 44.4-74.6, eight tablets of 5-mg oxycodone) after laparoscopic hysterectomy, and 108.1 (95% CI 80.5-135.8, 14.5 tablets of 5-mg oxycodone) after abdominal hysterectomy. Patients used 22.4 MME (95% CI 12.4-32.3, three tablets of 5-mg oxycodone) within 24 hours of discharge after laparoscopic procedures without hysterectomy and 79.8 MME (95% CI 37.1-122.6, 10.5 tablets of 5-mg oxycodone) from discharge to 7 or 14 days postdischarge after surgery for prolapse. Persistent opioid use occurred in about 4.4% of patients after gynecologic surgery, but this outcome had high heterogeneity due to variation in populations and definitions of the outcome. CONCLUSION: On average, patients use the equivalent of 15 or fewer 5-mg oxycodone tablets (or equivalent) in the 2 weeks after discharge after major gynecologic surgery for benign indications. Persistent opioid use occurred in 4.4% of patients who underwent gynecologic surgery for benign indications. Our findings could help surgeons minimize overprescribing and reduce medication diversion or misuse. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42020146120.

Characteristics associated with subjective and objective measures of treatment success in women undergoing percutaneous tibial nerve stimulation vs sham for accidental bowel leakage.

INTRODUCTION AND HYPOTHESIS: In randomized trials both percutaneous tibial nerve stimulation (PTNS) and sham result in clinically significant improvements in accidental bowel leakage (ABL). We aimed to identify subgroups who may preferentially benefit from PTNS in women enrolled in a multicenter randomized trial. METHODS: This planned secondary analysis explored factors associated with success for PTNS vs sham using various definitions: treatment responder using three cutoff points for St. Mark's score (≥3-, ≥4-, and ≥5-point reduction); Patient Global Impression of Improvement (PGI-I) of ≥ much better; and ≥50% reduction in fecal incontinence episodes (FIEs). Backward logistic regression models were generated using elements with significance of p<0.2 for each definition and interaction terms assessed differential effects of PTNS vs sham. RESULTS: Of 166 women randomized, 160 provided data for at least one success definition. Overall, success rates were 65% (102 out of 158), 57% (90 out of 158), and 46% (73 out of 158) for ≥3-, ≥4-, and ≥5-point St Mark's reduction respectively; 43% (68 out of 157) for PGI-I; and 48% (70 out of 145) for ≥50% FIEs. Of those providing data for all definitions of success, 77% (109 out of 142) met one success criterion, 43% (61 out of 142) two, and 29% (41 out of 142) all three success criteria. No reliable or consistent factors were associated with improved outcomes with PTNS over sham regardless of definition. CONCLUSIONS: Despite exploring diverse success outcomes, no subgroups of women with ABL differentially responded to PTNS over sham. Success results varied widely across subjective and objective definitions. Further investigation of ABL treatment success definitions that consistently and accurately capture patient symptom burden and improvement are needed.

Gynecologic surgical skill acquisition through simulation with outcomes at the time of surgery: a systematic review and meta-analysis.

OBJECTIVE: To evaluate the effect of simulation training vs traditional hands-on surgical instruction on learner operative skills and patient outcomes in gynecologic surgeries. DATA SOURCES: PubMed, Embase, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials from inception to January 12, 2021. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials, prospective comparative studies, and prospective single-group studies with pre- and posttraining assessments that reported surgical simulation-based training before gynecologic surgery were included. METHODS: Reviewers independently identified the studies, obtained data, and assessed the study quality. The results were analyzed according to the type of gynecologic surgery, simulation, comparator, and outcome data, including clinical and patient-related outcomes. The maximum likelihood random effects model meta-analyses of the odds ratios and standardized mean differences were calculated with estimated 95% confidence intervals. RESULTS: Twenty studies, including 13 randomized controlled trials, 1 randomized crossover trial, 5 nonrandomized comparative studies, and 1 prepost study were identified. Most of the included studies (14/21, 67%) were on laparoscopic simulators and had a moderate quality of evidence. Meta-analysis showed that compared with traditional surgical teaching, high- and low-fidelity simulators improved surgical technical skills in the operating room as measured by global rating scales, and high-fidelity simulators decreased the operative time. Moderate quality evidence was found favoring warm-up exercises before laparoscopic surgery. There was insufficient evidence to conduct a meta-analysis for other gynecologic procedures. CONCLUSION: Current evidence supports incorporating simulation-based training for a variety of gynecologic surgeries to increase technical skills in the operating room, but data on patient-related outcomes are lacking.

Recommended standardized anatomic terminology of the posterior female pelvis and vulva based on a structured medical literature review.

BACKGROUND: Anatomic terminology in both written and verbal forms has been shown to be inaccurate and imprecise. OBJECTIVE: Here, we aimed to (1) review published anatomic terminology as it relates to the posterior female pelvis, posterior vagina, and vulva; (2) compare these terms to "Terminologia Anatomica," the internationally standardized terminology; and (3) compile standardized anatomic terms for improved communication and understanding. STUDY DESIGN: From inception of the study to April 6, 2018, MEDLINE database was used to search for 40 terms relevant to the posterior female pelvis and vulvar anatomy. Furthermore, 11 investigators reviewed identified abstracts and selected those reporting on posterior female pelvic and vulvar anatomy for full-text review. In addition, 11 textbook chapters were included in the study. Definitions of all pertinent anatomic terms were extracted for review. RESULTS: Overall, 486 anatomic terms were identified describing the vulva and posterior female pelvic anatomy, including the posterior vagina. "Terminologia Anatomica" has previously accepted 186 of these terms. Based on this literature review, we proposed the adoption of 11 new standardized anatomic terms, including 6 regional terms (anal sphincter complex, anorectum, genital-crural fold, interlabial sulcus, posterior vaginal compartment, and sacrospinous-coccygeus complex), 4 structural terms (greater vestibular duct, anal cushions, nerve to the levator ani, and labial fat pad), and 1 anatomic space (deep postanal space). In addition, the currently accepted term rectovaginal fascia or septum was identified as controversial and requires further research and definition before continued acceptance or rejection in medical communication. CONCLUSION: This study highlighted the variability in the anatomic nomenclature used in describing the posterior female pelvis and vulva. Therefore, we recommended the use of standardized terminology to improve communication and education across medical and anatomic disciplines.

Standardized terminology of apical structures in the female pelvis based on a structured medical literature review.

The objectives of this study were to review the published literature and selected textbooks, to compare existing usage to that in Terminologia Anatomica, and to compile standardized anatomic nomenclature for the apical structures of the female pelvis. MEDLINE was searched from inception until May 30, 2017, based on 33 search terms generated by group consensus. Resulting abstracts were screened by 11 reviewers to identify pertinent studies reporting on apical female pelvic anatomy. Following additional focused screening for rarer terms and selective representative random sampling of the literature for common terms, accepted full-text manuscripts and relevant textbook chapters were extracted for anatomic terms related to apical structures. From an initial total of 55,448 abstracts, 193 eligible studies were identified for extraction, to which 14 chapters from 9 textbooks were added. In all, 293 separate structural terms were identified, of which 184 had Terminologia Anatomica-accepted terms. Inclusion of several widely used regional terms (vaginal apex, adnexa, cervico-vaginal junction, uretero-vesical junction, and apical segment), structural terms (vesicouterine ligament, paracolpium, mesoteres, mesoureter, ovarian venous plexus, and artery to the round ligament) and spaces (vesicocervical, vesicovaginal, presacral, and pararectal) not included in Terminologia Anatomica is proposed. Furthermore, 2 controversial terms (lower uterine segment and supravaginal septum) were identified that require additional research to support or refute continued use in medical communication. This study confirms and identifies inconsistencies and gaps in the nomenclature of apical structures of the female pelvis. Standardized terminology should be used when describing apical female pelvic structures to facilitate communication and to promote consistency among multiple academic, clinical, and surgical disciplines.

Vaginal Hysterectomy Suturing Skills Training Model and Curriculum.

BACKGROUND: Declining vaginal hysterectomy numbers in obstetrics and gynecology training programs highlights the need for innovative methods to teach vaginal surgical skills. We describe our experience with a vaginal hysterectomy skills simulation curriculum. INSTRUMENT: A low-fidelity bench model was constructed to simulate four vaginal hysterectomy suturing tasks. A polyvinyl chloride downspout adapter and low-cost materials simulate the Heaney pedicle stitch, simple pedicle stitch, double ligature, and continuous running stitch. EXPERIENCE: Faculty expert vaginal surgeons established proficiency levels for each task. Resident (N=30) pass rates for tasks 1, 2, and 3 were 1 of 30 (3.3%), 7 of 30 (23.3%), and 4 of 30 (13.3%), respectively, for the left side, and 3 of 30 (10%), 9 of 30 (30%), and 10 of 30 (33.3%), respectively, for the right side. For task 4, the pass rate was 14 of 30 (46.7%). The majority of residents felt that the model simulates the technical skills required for vaginal hysterectomy and agreed that vaginal skills laboratory training would improve their ability to perform procedures in the operating room. Ninety-two percent of residents felt that a vaginal surgery skills curriculum would be a useful addition to their simulation education. CONCLUSION: A proficiency-based vaginal hysterectomy skills simulation curriculum using a low-fidelity model may be an important training and evaluation tool for vaginal surgical skills training.

Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study.

BACKGROUND/AIMS: In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. METHODS: Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student's t-test (continuous) and chi-square or Fisher's exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05. RESULTS: Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being "very satisfied" overall with study information (97.7% vs 88.5%, p = 0.01); "strong agreement" for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being "very important" (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group. CONCLUSION: The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.

Recommended standardized terminology of the anterior female pelvis based on a structured medical literature review.

BACKGROUND: The use of imprecise and inaccurate terms leads to confusion amongst anatomists and medical professionals. OBJECTIVE: We sought to create recommended standardized terminology to describe anatomic structures of the anterior female pelvis based on a structured review of published literature and selected text books. STUDY DESIGN: We searched MEDLINE from its inception until May 2, 2016, using 11 medical subject heading terms to identify studies reporting on anterior female pelvic anatomy; any study type published in English was accepted. Nine textbooks were also included. We screened 12,264 abstracts, identifying 200 eligible studies along with 13 textbook chapters from which we extracted all pertinent anatomic terms. RESULTS: In all, 67 unique structures in the anterior female pelvis were identified. A total of 59 of these have been previously recognized with accepted terms in Terminologia Anatomica, the international standard on anatomical terminology. We also identified and propose the adoption of 4 anatomic regional terms (lateral vaginal wall, pelvic sidewall, pelvic bones, and anterior compartment), and 2 structural terms not included in Terminologia Anatomica (vaginal sulcus and levator hiatus). In addition, we identified 2 controversial terms (pubourethral ligament and Grafenberg spot) that require additional research and consensus from the greater medical and scientific community prior to adoption or rejection of these terms. CONCLUSION: We propose standardized terminology that should be used when discussing anatomic structures in the anterior female pelvis to help improve communication among researchers, clinicians, and surgeons.

Comparison of Vaginal Hysterectomy Techniques and Interventions for Benign Indications: A Systematic Review.

OBJECTIVE: To create evidence-based clinical practice guidelines based on a systematic review of published literature regarding the risks and benefits of available preoperative, intraoperative, and postoperative technical steps and interventions at the time of vaginal hysterectomy for benign indications. DATA SOURCES: We systematically searched the literature to identify studies that compared technical steps or interventions during the preoperative, intraoperative, and postoperative periods surrounding vaginal hysterectomy. We searched MEDLINE, Cochrane Central Register of Controlled Trials, Health Technology Assessments, and ClinicalTrials.gov from their inception until April 10, 2016, using the MeSH term "Hysterectomy, Vaginal" and associated text words. We included comparative studies, single-group studies, and systematic reviews published in English. METHODS OF STUDY SELECTION: We double-screened 4,250 abstracts, identifying 60 eligible studies. Discrepancies were adjudicated by a third reviewer. We followed standard systematic review methodology and the Grades for Recommendation, Assessment, Development and Evaluation approach to evaluate the evidence and generate guideline recommendations. TABULATION, INTEGRATION, AND RESULTS: Because of limited literature, only 16 perioperative risks, technical steps, and interventions were identified: obesity, large uteri, prior surgery, gonadotropin-releasing hormone agonists, vaginal antisepsis, bilateral salpingo-oophorectomy, morcellation, apical closure, uterine sealers, hemostatic injectants, hot cone, retractor, cystoscopy, vaginal packing, bladder management, and accustimulation. We organized and reported these as four domains: patient selection, preoperative, intraoperative, and postoperative. We did not identify any patient characteristics precluding a vaginal approach; chlorhexidine or povidone is appropriate for vaginal antisepsis; vasopressin decreases blood loss by 130 cc; tissue-sealing devices decrease blood loss by 44 cc and operative time by 15 minutes with uncertain complication implications; vertical cuff closure results in 1-cm increased vaginal length; either peritoneum or epithelium can be used for colpotomy closure; and routine vaginal packing is not advised. CONCLUSION: Minimal data exist to guide surgeons with respect to planning and performing a vaginal hysterectomy. This study identifies available information and future areas for investigation.

Effect of mesh width on apical support after sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: We evaluated the effect of polypropylene mesh width on vaginal apical support, mesh elongation, and mesh tensile strength for abdominal sacrocolpopexy. METHODS: Abdominal sacrocolpopexy was performed on ten cadavers using pieces of polypropylene mesh of width 1, 2, and 3 cm. Weights of 1, 2, 3, and 4 kg were sequentially applied to the vagina. The total distance moved by the vaginal apex, and the amount of stretch of the intervening mesh segment between the sacrum and the vagina were recorded for each width. The failure strengths of additional single and double layer sets of each width were also tested using a tensiometer. Data were analyzed with analysis of variance using a random effects model. RESULTS: The mean (standard error of the mean) maximum distance moved by the vaginal apex was 4.63 cm (0.37 cm) for the 1 cm mesh compared to 3.67 cm (0.26 cm) and 2.73 cm (0.14 cm) for the 2 and 3 cm meshes, respectively (P < 0.0001). The 1 cm width ruptured during testing in four of the ten cadavers. The results were similar for mesh elongation, with the 1 cm mesh stretching the most and the 3 cm mesh stretching the least. Mesh failure loads for double-layer mesh were 52.9 N (2.5 N), 124.4 N (2.7 N), and 201.2 N (4.5 N) for the 1, 2, and 3 cm meshes, respectively, and were higher than the failure loads for single mesh (P < 0.001). CONCLUSIONS: In a cadaver model, increasing mesh width is associated with better vaginal apical support, less mesh elongation, and higher failure loads. Mesh widths of 2-3 cm provide sufficient repair strength for sacrocolpopexy.

Distance From Cervicovaginal Junction to Anterior Peritoneal Reflection Measured During Vaginal Hysterectomy.

OBJECTIVE: To quantify the distance of the dissection plane from the cervicovaginal junction to the anterior peritoneal reflection for vaginal hysterectomy. METHODS: This is a descriptive study examining the dissection plane for anterior colpotomy in 22 surgical patients undergoing vaginal hysterectomy and in nine cadaver specimens. Intraoperatively, the distance from the vaginal incision to the anterior peritoneal reflection was measured on the uterus after removal. In nine of these patients, this distance was also measured before anterior peritoneal incision. Embalmed cadavers with intact pelvic viscera were dissected and the distance of the same dissection plane was measured. RESULTS: Median (interquartile range) surgical patient age was 51.5 (42-63) years and the main surgical indications were abnormal uterine bleeding and pelvic organ prolapse. In these patients, the median (interquartile range) distance from cervicovaginal incision to anterior peritoneal reflection was 3.4 (2.6-3.7) cm. In cadavers, the median (interquartile range) age was 81 (72-86) years with a measured distance of 2.7 (2.4-2.9) cm. CONCLUSION: When performing a vaginal hysterectomy, surgeons can expect a median (range) dissection distance of 3.4 (1.8-4.6) cm from initial incision to the peritoneal reflection for anterior colpotomy.

Pelvic Organ Support in Animals with Partial Loss of Fibulin-5 in the Vaginal Wall.

Compromise of elastic fiber integrity in connective tissues of the pelvic floor is most likely acquired through aging, childbirth-associated injury, and genetic susceptibility. Mouse models of pelvic organ prolapse demonstrate systemic deficiencies in proteins that affect elastogenesis. Prolapse, however, does not occur until several months after birth and is thereby acquired with age or after parturition. To determine the impact of compromised levels of fibulin-5 (Fbln5) during adulthood on pelvic organ support after parturition and elastase-induced injury, tissue-specific conditional knockout (cKO) mice were generated in which doxycycline (dox) treatment results in deletion of Fbln5 in cells that utilize the smooth muscle α actin promoter-driven reverse tetracycline transactivator and tetracycline responsive element-Cre recombinase (i.e., Fbln5f/f/SMA++-rtTA/Cre+, cKO). Fbln5 was decreased significantly in the vagina of cKO mice compared with dox-treated wild type or controls (Fbln5f/f/SMA++-rtTA/Cre-/-). In controls, perineal body length (PBL) and bulge increased significantly after delivery but declined to baseline values within 6-8 weeks. Although overt prolapse did not occur in cKO animals, these transient increases in PBL postpartum were amplified and, unlike controls, parturition-induced increases in PBL (and bulge) did not recover to baseline but remained significantly increased for 12 wks. This lack of recovery from parturition was associated with increased MMP-9 and nondetectable levels of Fbln5 in the postpartum vagina. This predisposition to prolapse was accentuated by injection of elastase into the vaginal wall in which overt prolapse occurred in cKO animals, but rarely in controls. Taken together, our model system in which Fbln5 is conditionally knock-downed in stromal cells of the pelvic floor results in animals that undergo normal elastogenesis during development but lose Fbln5 as adults. The results indicate that vaginal fibulin-5 during development is crucial for baseline pelvic organ support and is also important for protection and recovery from parturition- and elastase-induced prolapse.

Safety of Manual Morcellation After Vaginal or Laparoscopic-assisted Vaginal Hysterectomy.

UNLABELLED: STUDY OBJECTIVE: To determine the safety of manual vaginal morcellation by evaluating the rates of incidental uterine malignancy and manual vaginal morcellation after vaginal or laparoscopic-assisted vaginal hysterectomy. DESIGN: Retrospective analysis (Canadian Task Force classification II-2). SETTING: University of Texas Southwestern Medical Center, Dallas, TX. PATIENTS: Women (n = 1,629) undergoing vaginal or laparoscopic-assisted vaginal hysterectomy. INTERVENTIONS: Vaginal hysterectomy (n = 1,091) or laparoscopic-assisted vaginal hysterectomy (n = 538) with and without scalpel morcellation. MEASUREMENTS AND MAIN RESULTS: The number of uterine malignancies, rate of vaginal morcellation, surgical indications, pathology diagnoses, and uterine weights were evaluated. Chi-square analysis was used to compare categoric data, and analysis of variance was used to compare uterine weights. There were no cases of leiomyosarcomas. There were 2 other sarcomas, 4 smooth muscle tumors of uncertain malignant potential, and 8 endometrial adenocarcinomas. The vaginal morcellation rate was 19.4%, but no malignancy was morcellated. Myomas were more common preoperatively and histologically in morcellated specimens. Mean (± standard deviation) uterine weights for morcellated versus nonmorcellated laparoscopic-assisted vaginal hysterectomy specimens were 285.5 ± 159.3 versus 140.1 ± 83.6 g (p < .001), respectively, and 199.9 ± 92.8 versus 111.9 ± 61.4 (p < .001), respectively, for vaginal hysterectomy. CONCLUSION: Vaginal manual morcellation is safe with a low risk of incidental malignancy. Variables that influence the decision for the vaginal approach may also affect malignancy risk and morcellation decisions. Thus, all patients undergoing vaginal or laparoscopic-assisted vaginal hysterectomy should be counseled regarding incidental malignancy, risk of morcellation, and alternatives for intact specimen removal.