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BACKGROUND: Current evidence supports that many patients do not use prescribed opioids following reconstructive pelvic surgery, yet it remains unclear if it is feasible to eliminate routine opioid prescriptions without a negative impact on patients or providers. OBJECTIVE: To determine if there is a difference in the proportion of patients discharged without opioids after implementing a bundle of opioid-sparing strategies and tiered prescribing protocol compared to usual care after minimally invasive pelvic reconstructive surgery (transvaginal, laparoscopic, or robotic). Secondary objectives include measures of patient-perceived pain control and provider workload. STUDY DESIGN: The bundle of opioid-sparing strategies and tiered prescribing protocol intervention was implemented as a division-wide evidence-based practice change on August 1, 2022. This retrospective cohort compares a 6-month postintervention (bundle of opioid-sparing strategies and tiered prescribing protocol) cohort to 6-month preintervention (usual care) of patients undergoing minimally invasive pelvic reconstructive surgery. A 3-month washout period was observed after bundle of opioid-sparing strategies and tiered prescribing protocol initiation. We excluded patients <18 years, failure to consent to research, combined surgery with other specialties, urge urinary incontinence or urinary retention procedures alone, and minor procedures not typically requiring opioids. Primary outcome was measured by proportion discharged without opioids and total oral morphine equivalents prescribed. Pain control was measured by pain scores, postdischarge prescriptions and refills, phone calls and visits related to pain, and satisfaction with pain control. Provider workload was demonstrated by phone calls and postdischarge prescription refills. Data were obtained through chart review on all patients who met inclusion criteria. Primary analysis only included patients prescribed opioids according to the bundle of opioid-sparing strategies and tiered prescribing protocol protocol. Two sample t tests compared continuous variables and chi-square tests compared categorical variables. RESULTS: Four hundred sixteen patients were included in the primary analysis (207 bundle of opioid-sparing strategies and tiered prescribing protocol, 209 usual care). Baseline demographics were similar between groups, except a lower proportion of irritable bowel syndrome (13% vs 23%; P<.01) and pelvic pain (15% vs 24.9%; P=.01), and higher history of prior gynecologic surgery (69.1% vs 58.4%; P=.02) in the bundle of opioid-sparing strategies and tiered prescribing protocol cohort. The bundle of opioid-sparing strategies and tiered prescribing protocol cohort was more likely to be discharged without opioids (68.1% vs 10.0%; P<.01). In those prescribed opioids, total oral morphine equivalents on discharge was significantly lower in the bundle of opioid-sparing strategies and tiered prescribing protocol cohort (48.1 vs 81.8; P<.01). The bundle of opioid-sparing strategies and tiered prescribing protocol cohort had a 20.6 greater odds (confidence interval 11.4, 37.1) of being discharged without opioids after adjusting for surgery type, arthritis/joint pain, IBS, pelvic pain, and contraindication to nonsteroidal anti-inflammatory drugs. The bundle of opioid-sparing strategies and tiered prescribing protocol cohort was also less likely to receive a rescue opioid prescription after discharge (1.4% vs 9.5%; P=.03). There were no differences in opioid prescription refills (19.7% vs 18.1%; P=.77), emergency room visits for pain (3.4% vs 2.9%; P=.76), postoperative pain scores (mean 4.7 vs 4.0; P=.07), or patient satisfaction with pain control (81.5% vs 85.6%; P=.21). After bundle of opioid-sparing strategies and tiered prescribing protocol implementation, the proportion of postoperative phone calls for pain also decreased (12.6% vs 21.5%; P=.02). Similar results were identified when nonadherent prescribing was included in the analysis. CONCLUSION: A bundle of evidence-based opioid sparing strategies and tiered prescribing based on inpatient use increases the proportion of patients discharged without opioids after minimally invasive pelvic reconstructive surgery without evidence of uncontrolled pain or increased provider workload.
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Analgésicos Opioides , Prescrições de Medicamentos , Dor Pós-Operatória , Padrões de Prática Médica , Humanos , Analgésicos Opioides/uso terapêutico , Feminino , Dor Pós-Operatória/tratamento farmacológico , Estudos Retrospectivos , Pessoa de Meia-Idade , Padrões de Prática Médica/estatística & dados numéricos , Prescrições de Medicamentos/estatística & dados numéricos , Procedimentos Cirúrgicos em Ginecologia , Idoso , Adulto , Manejo da Dor/métodos , Procedimentos de Cirurgia Plástica , Procedimentos Cirúrgicos Minimamente Invasivos , Estudos de CoortesRESUMO
This is a single Institute, prospective cohort study. We collected twenty- two postmenopausal women with pelvic organ prolapse planning to undergo vaginal hysterectomy with transvaginal pelvic reconstructive surgery, with or without a concomitant anti-incontinence procedure. Vaginal swabs and urine samples were longitudinally collected at five time points: preoperative consult visit (T1), day of surgery prior to surgical scrub (T2), immediately postoperative (T3), day of hospital discharge (T4), and at the postoperative exam visit (T5). Women experiencing urinary tract infection symptoms provided a sample set prior to antibiotic administration (T6). Microbiome analysis on vaginal and urinary specimens at each time point. Region V3-V5 of the 16S ribosomal RNA gene was amplified and sequenced. Sample DNA was analyzed with visit T1, T2, T5 and T6. Six (27.3%) participants developed postoperative urinary tract infection whose vaginal sample at first clinical visit (T1) revealed beta-diversity analysis with significant differences in microbiome structure and composition. Women diagnosed with a postoperative urinary tract infection had a vaginal microbiome characterized by low abundance of Lactobacillus and high prevalence of Prevotella and Gardnerella species. In our cohort, preoperative vaginal swabs can predict who will develop a urinary tract infection following transvaginal surgery for pelvic organ prolapse.
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IMPORTANCE: Racial and ethnic disparities exist in urogynecologic surgery; however, literature identifying specific disparities after sling operations for stress incontinence are limited. OBJECTIVE: The objective of this study was to evaluate racial and ethnic disparities in surgical complications within 30 days of midurethral sling operations. STUDY DESIGN: This retrospective cohort study identified women who underwent an isolated midurethral sling operation between 2014 and 2021 using the American College of Surgeons National Surgical Quality Improvement Program database. Women were stratified by racial and ethnic category to assess the primary outcome, 30-day surgical complications, and the secondary outcome, comparison of urinary tract infections (UTIs). RESULTS: There were 20,066 patients included. Mean age and body mass index were 53.9 years and 30.8, respectively. More Black or African American women had diabetes and hypertension, and more American Indian or Alaska Native women used tobacco. The only difference in 30-day complications was stroke/cerebrovascular accident, which occurred in only 1 Asian, Native Hawaiian or other Pacific Islander patient (0.1%, P < 0.0001). The most frequent complication was UTI (3.3%). Black or African American women were significantly less likely to have a diagnosis of UTI than non-Hispanic White (P = 0.04), Hispanic White (P = 0.03), and American Indian or Alaska Native women (P = 0.04). CONCLUSIONS: Surgical complications within 30 days of sling operations are rare. No clinically significant racial and ethnic differences in serious complications were observed. Urinary tract infection diagnoses were lower among Black or African American women than in non-Hispanic White, Hispanic White, and American Indian or Alaska Native women despite a greater comorbidity burden. No known biologic reason exists to explain lower UTI rates in this population; therefore, this finding may represent a disparity in diagnosis and treatment.
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Grupos Raciais , Incontinência Urinária , Infecções Urinárias , Feminino , Humanos , Etnicidade , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Infecções Urinárias/epidemiologia , Pessoa de Meia-IdadeRESUMO
IMPORTANCE: Obesity adds complexity to the decision of surgical approach for pelvic organ prolapse; data regarding perioperative complications are needed. OBJECTIVE: The aim of the study was to evaluate associations of body mass index (BMI) and surgical approach (vaginal vs laparoscopic) on perioperative complications. STUDY DESIGN: Patients who underwent prolapse surgery were identified via the Current Procedural Terminology codes from the American College of Surgeons National Surgical Quality Improvement Program database 2007-2018. Thirty-day major complications were compared across BMI to identify an inflection point, to create a dichotomous BMI variable. Multivariable logistic regression was used to assess the association between BMI and complications. An interaction term was introduced to evaluate for effect modification by operative approach. RESULTS: A total of 26,940 patients were identified (25,933 BMI < 40, 1,007 BMI ≥ 40). The proportion of patients experiencing a major complication was higher in the BMI ≥ 40 group (2.0 vs 1.1%, P = 0.007). In multivariate analysis, the odds of a major complication was 1.8 times higher for women with a BMI ≥ 40 (95% confidence interval, 1.1-2.9, P = 0.04). There was a significant interaction between operative approach and BMI; therefore, further analyses were restricted to either vaginal or laparoscopic operative approaches. Among women who underwent vaginal prolapse repair, there was no difference in the odds of a major complication (adjusted odds ratio, 1.4; 0.8-2.4; P = 0.06). Among women who underwent laparoscopic repair, those with a BMI ≥ 40 were 6 times more likely to have a major complication (adjusted odds ratio, 6.0; 2.5-14.6; P < 0.001). CONCLUSIONS: Body mass index ≥ 40 was associated with an increased odds of a 30-day major complication. This association was greatest in women who underwent a laparoscopic prolapse repair.
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PURPOSE: Pelvic organ prolapse (POP) surgery is performed with and without concomitant hysterectomy depending on a variety of factors. The objective was to compare 30-day major complications following POP surgery with and without concomitant hysterectomy. METHODS: This was a retrospective cohort study using the National Surgical Quality Improvement Program (NSQIP) multicenter database to compare 30-day complications using Current Procedural Terminology (CPT) codes for POP with or without concomitant hysterectomy. Patients were grouped by procedure: Vaginal prolapse repair (VAGINAL), minimally invasive sacrocolpopexy (MISC), and open abdominal sacrocolpopexy (OASC). 30-day postoperative complications and other relevant data were evaluated in patients who underwent concomitant hysterectomy compared to those who did not. Multivariable logistic regression models assessed the association of concomitant hysterectomy on 30-day major complications stratified by surgical approach. RESULTS: 60,201 women undergoing POP surgery comprised our cohort. Within 30 days of surgery, there were 1722 major complications in 1432 patients (2.4%). Prolapse surgery alone had a significantly lower overall complication rate than with concomitant hysterectomy (1.95% vs 2.81%; p < .001). Multivariable analysis revealed odds of complications following POP surgery was higher among women who underwent concomitant hysterectomy compared to those who did not have hysterectomy in VAGINAL (OR 1.53, 95% CI 1.36-1.72), OASC (OR 2.70, 95% CI 1.69-4.33), and overall (OR 1.46, 95% CI 1.31-1.62), but not in MISC (OR 0.99, 95% CI 0.67-1.46.) CONCLUSION: Concomitant hysterectomy at the time of pelvic organ prolapse (POP) surgery increases the risk of 30-day postoperative complications in comparison to prolapse surgery alone in our overall cohort.
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Histerectomia , Prolapso de Órgão Pélvico , Feminino , Humanos , Estudos Retrospectivos , Histerectomia/efeitos adversos , Prolapso de Órgão Pélvico/cirurgia , Prolapso de Órgão Pélvico/etiologia , Vagina/cirurgia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgiaRESUMO
IMPORTANCE: Improving opioid stewardship is important, given the common use of opioids and resultant adverse events. Evidence-based prescribing recommendations for surgeons may help reduce opioid prescribing after specific procedures. OBJECTIVE: The aim of this study was to assess longitudinal prescribing patterns for patients undergoing pelvic organ prolapse surgery in the 2 years before and after implementing evidence-based opioid prescribing recommendations. STUDY DESIGN: In December 2017, a 3-tiered opioid prescribing recommendation was created based on prospective data on postoperative opioid use after pelvic organ prolapse surgery. For this follow-up study, prescribing patterns, including quantity of opioids prescribed (in oral morphine equivalents [OMEs]) and refill rates, were retrospectively compared for patients undergoing prolapse surgery before (November 2015-November 2017; n = 238) and after (December 2017-December 2019; n = 361) recommendation implementation. Univariate analysis was performed using the Wilcoxon rank sum and χ2 tests. Cochran-Armitage trend tests and interrupted time-series analysis tested for significance in the change in OMEs prescribed before versus after recommendation implementation. RESULTS: After recommendation implementation, the quantity of postoperative opioids prescribed decreased from median 225 mg OME (interquartile range, 225, 300 mg OME) to 71.3 mg OME (interquartile range, 0, 112.5 mg OME; P < 0.0001). Decreases also occurred within each subgroup of prolapse surgery: native tissue vaginal repair ( P < 0.0001), robotic sacrocolpopexy ( P < 0.0001), open sacrocolpopexy ( P < 0.0001), and colpocleisis ( P < 0.003). The proportion of patients discharged following prolapse surgery without opioids increased (4.2% vs 36.6%; P < 0.0001), and the rate of opioid refills increased (2.1% vs 6.0%; P = 0.02). CONCLUSIONS: With 2 years of postimplementation follow-up, the use of procedure-specific, tiered opioid prescribing recommendations at our institution was associated with a significant, sustained reduction in opioids prescribed. This study further supports using evidence-based recommendations for opioid prescribing.
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Analgésicos Opioides , Prolapso de Órgão Pélvico , Feminino , Humanos , Analgésicos Opioides/efeitos adversos , Estudos Retrospectivos , Dor Pós-Operatória/tratamento farmacológico , Estudos Prospectivos , Seguimentos , Padrões de Prática Médica , Prolapso de Órgão Pélvico/cirurgia , MorfinaRESUMO
OBJECTIVE: The aim of this study was to investigate trends and outcomes of ambulatory minimally invasive sacrocolpopexy (MISC) using data from a contemporary multicenter nationwide cohort. METHODS: We used the American College of Surgeons National Surgical Quality Improvement Program database to identify women who underwent nonemergent MISC (laparoscopic and robotic) from 2012 to 2018. Exclusion criteria were age <18 or ≥90 years, rectal prolapse, postoperative discharge day ≥3, and concomitant hysterectomy, transvaginal mesh repair, colpocleisis, and/or colorectal surgery. Baseline demographics and 30-day outcomes were compared between patients who underwent same-day discharge (SDD; discharge on postoperative day [POD] 0) and those discharged on POD 1-2 using Kruskal-Wallis, Fisher exact, and Pearson χ2 tests. A 2-sided Cochran-Armitage trend test assessed SDD over time, and person-years methodology was used to assess readmission rates. Multivariable logistic regression and Cox proportional hazards modeling evaluated associations between SDD and postoperative outcomes. We hypothesized that SDD increased over the study time frame and is not associated with adverse outcomes. RESULTS: Of 2,928 women, 362 (12.4%) were SDD, and 2,566 (87.6%) were discharged POD 1-2. The proportion of SDD nearly quadrupled over time (5.6% [2012], 20.6% [2018]; P < 0.001). The SDD group was younger (mean age, 61.9 vs 63.6; P = 0.04), with lower proportion of American Society of Anesthesiologists class III or higher (21.8% vs 27.5%; P = 0.02) and hypertension (37.3% vs.46.5%; P < 0.001), shorter total operation time (median, 142 vs 172 minutes; P < 0.001), and fewer concomitant slings (21.5% vs 33.0%; P < 0.001). Outcomes were similar for SDD: 30-day overall complications (3.0% vs 4.4%; P = 0.23), readmissions (1.1% vs 2.0%; P = 0.28), and reoperations (1.1% vs 0.9%; P = 0.55) and persisted with multivariable analysis. CONCLUSION: Ambulatory MISC significantly increased during the study period and appears safe and feasible in select patients.
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Laparoscopia , Prolapso de Órgão Pélvico , Idoso de 80 Anos ou mais , Bases de Dados Factuais , Feminino , Humanos , Tempo de Internação , Pessoa de Meia-Idade , Duração da Cirurgia , Alta do Paciente , Prolapso de Órgão Pélvico/cirurgia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Estudos RetrospectivosRESUMO
INTRODUCTION AND HYPOTHESIS: The objective of this video was to demonstrate the build and use of a single robotic simulation model for a double-layer vaginal cuff closure and sacrocolpopexy vaginal mesh attachment. Simulation models are frequently used to improve surgical skills and augment operating room experience for surgical trainees. METHODS: To create our robotic simulation model, we utilized the Advincula arch manipulator handle with a sacrocolpopexy tip attached to the ALLY Uterine Positioning System. To simulate the vagina, we used a pink, slim can cooler/coozie attached to the sacrocolpopexy tip. The edges of the coozie represented the vaginal cuff following a hysterectomy. Mesh attachment was demonstrated using a precut Y-shaped polypropylene mesh. CONCLUSIONS: Simulation has become a critical part of education in surgical training programs as it enhances learner knowledge and improves surgical confidence and preparedness in the operative setting.
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Laparoscopia , Prolapso de Órgão Pélvico , Procedimentos Cirúrgicos Robóticos , Feminino , Humanos , Histerectomia , Prolapso de Órgão Pélvico/cirurgia , Polipropilenos , Procedimentos Cirúrgicos Robóticos/educação , Telas Cirúrgicas , Vagina/cirurgiaRESUMO
PURPOSE: We compared the degree of pelvic floor symptom improvement between pessary use and prolapse surgery. MATERIALS AND METHODS: Pessary-naïve women who elected prolapse surgery were enrolled and used a pessary preoperatively (for ≥7 days and ≤30 days). Pelvic floor symptoms were assessed at baseline, after pessary use, and at 3 months postoperatively. The primary outcome was concordance in the degree of symptoms improvement between pessary use and surgery, as assessed by Patient Global Impression of Improvement (PGI-I). Secondary outcomes were related to prolapse specific symptoms on validated questionnaires (POPDI-6, PFIQ-7). The McNemar test was used for comparisons of discordant pairs for comparisons of the PGI-I ratings after pessary use and surgery. RESULTS: Sixty-one participants were enrolled (March 2016 through April 2019) and 58 patients used a pessary. Mean±standard deviation age was 60.7±10.7 years; 24.1% had prior hysterectomy, and 13.8% had prior prolapse surgery. While both treatments demonstrated symptomatic improvement, concordance in the degree of overall improvement on the PGI-I score was poor (n=40); responses significantly favored more improvement postoperatively (p<0.001). Pessary use and surgery were associated with significant improvements in prolapse symptoms from baseline on POPDI-6 (both p<0.001) and POPIQ-7 (pessary, p=0.002; surgery, p<0.001). The degree of improvement was larger postoperatively compared to post-pessary use on POPDI-6 (p<0.001) and PFIQ-7 (p=0.004). CONCLUSIONS: Both pessary use and surgery significantly improved pelvic floor symptoms from baseline. However, concordance in degrees of improvement between these treatments was poor, with more favorable outcomes after surgery for prolapse symptoms.
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Prolapso de Órgão Pélvico , Pessários , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Diafragma da Pelve , Prolapso de Órgão Pélvico/cirurgia , Estudos ProspectivosRESUMO
OBJECTIVE: The aim of this study was to perform a cost-effectiveness analysis comparing the management for ongoing voiding dysfunction after midurethral sling placement, including early sling loosening and delayed sling lysis. METHODS: A Markov model was created to compare the cost-effectiveness of early sling loosening (2 weeks) versus delayed sling lysis (6 weeks) for the management of persisting voiding dysfunction/retention after midurethral sling placement. A literature review provided rates of resolution of voiding dysfunction with conservative management, complications, recurrent stress urinary incontinence, or ongoing retention, as well as quality-adjusted life years (QALYs). Costs were based on 2020 Medicare reimbursement rates. Incremental cost-effectiveness ratios were compared using a willingness-to-pay threshold of $100,000/QALY. One-way and probabilistic sensitivity analyses were performed. RESULTS: At 1 year, early sling loosening resulted in increased costs ($3,575 vs $1,836) and higher QALYs (0.948 vs 0.925) compared with delayed sling lysis. This translated to early sling loosening being the most cost-effective strategy, with an incremental cost-effectiveness ratio of $74,382/QALY. The model was sensitive to multiple variables on our 1-way sensitivity analysis. For example, delayed sling lysis became cost-effective if the rate of voiding dysfunction resolution with conservative management was greater than or equal to 57% or recurrent stress urinary incontinence after early loosening was greater than or equal to 9.6%. At a willingness-to-pay threshold of 100,000/QALY, early sling loosening was cost-effective in 82% of microsimulations in probabilistic sensitivity analysis. CONCLUSIONS: Early sling loosening represents a more cost-effective management method in resolving ongoing voiding dysfunction after sling placement. These findings may favor early clinical management in patients with voiding dysfunction after midurethral sling placement.
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Slings Suburetrais , Incontinência Urinária por Estresse , Idoso , Análise Custo-Benefício , Feminino , Humanos , Masculino , Medicare , Anos de Vida Ajustados por Qualidade de Vida , Slings Suburetrais/efeitos adversos , Estados Unidos , Incontinência Urinária por Estresse/cirurgiaRESUMO
INTRODUCTION AND HYPOTHESIS: This video demonstrates surgical repair of a vesicouterine fistula via a robotic, uterine-sparing approach. METHODS: In this video, we present a vesicouterine fistula, which occurred after cesarean delivery. The patient presented with cyclical hematuria 4 years following delivery. She underwent uterine-conserving robotic repair via excision of the fistula tract through an intentional cystotomy. The uterus and bladder were closed in multiple layers. RESULTS: The patient tolerated the procedure well, and CT cystogram 6 weeks following surgery demonstrated no concern for defect or recurrent fistulization. The patient was asymptomatic 9 months following her procedure. CONCLUSION: Repair of a vesicouterine fistula may be safely completed via a minimally invasive approach without need for routine hysterectomy.
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Fístula , Procedimentos Cirúrgicos Robóticos , Robótica , Fístula da Bexiga Urinária , Doenças Uterinas , Feminino , Fístula/etiologia , Fístula/cirurgia , Humanos , Gravidez , Fístula da Bexiga Urinária/etiologia , Fístula da Bexiga Urinária/cirurgia , Doenças Uterinas/cirurgiaRESUMO
OBJECTIVES: The purpose of this study was to explore the utility of an injectable purified exosome product derived from human apheresis blood to (1) augment surgical closure of vaginal mesh exposures, and (2) serve as a stand-alone therapy for vaginal mesh exposure. METHODS: Sixteen polypropylene meshes (1×1-3×3 cm) were implanted in the vaginas of 7 Yorkshire-crossed pigs by urogynecologic surgeons (day 0). On day 7, group 1 underwent surgical intervention via vaginal tissue suture reclosure with (n=2 pigs, n=4 meshes) or without (n=2 pigs, n=4 meshes) exosome injection; group 2 underwent medical intervention with an exosome injection (n=3, n=8 meshes). One animal in group 2 was given oral 2'-deoxy-5-ethynyluridine to track cellular regeneration. Euthansia occurred at 5 weeks. RESULTS: Mesh exposures treated with surgical closure alone experienced reexposure of the mesh. Exosome treatment with or without surgical closure resulted in partial to full mesh exposure resolution up to 3×3 cm. Exosome-treated tissues had significantly thicker regenerated epithelial tissue (208 µm exosomes-only and 217 µm surgery+exosomes, versus 80 µm for surgery-only; P < 0.05); evaluation of 2'-deoxy-5-ethynyluridine confirmed de novo regeneration throughout the epithelium and underlying tissues. Capillary density was significantly higher in the surgery+exosomes group (P = 0.03). Surgery-only tissues had a higher inflammatory and fibrosis response as compared with exosome-treated tissues. CONCLUSIONS: In this pilot study, exosome treatment augmented healing in the setting of vaginal mesh exposure, reducing the incidence of mesh reexposure after suture closure and decreasing the area of mesh exposure through de novo tissue regeneration after exosome injection only. Further study of varied local tissue conditions and mesh configurations is warranted.
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Exossomos , Telas Cirúrgicas , Animais , Feminino , Humanos , Projetos Piloto , Polipropilenos , Telas Cirúrgicas/efeitos adversos , Suínos , Vagina/cirurgiaRESUMO
The objective was to demonstrate the build and use of a low-cost, moderate-fidelity simulation model for LeFort colpocleisis. We a present a video demonstrating the creation of a LeFort colpocleisis model, the mounting of this model to a pre-existing vaginal hysterectomy simulator (SimVaHT), and the use of the model to teach the steps of the LeFort colpocleisis procedure. This LeFort colpocleisis model is easy to make, from readily available materials, and is inexpensive. It can help trainees to enhance their intraoperative learning.
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Prolapso de Órgão Pélvico , Colpotomia , Simulação por Computador , Feminino , Procedimentos Cirúrgicos em Ginecologia , Humanos , Prolapso de Órgão Pélvico/cirurgia , Gravidez , Vagina/cirurgiaRESUMO
OBJECTIVE: The aim of the study was to compare vaginal wound healing after exosome injection in a porcine mesh exposure model with (1) single versus multiple dose regimens and (2) acute versus subacute exposure. METHODS: Six 80-kg Yorkshire-crossed swine each had 2 polypropylene meshes implanted to create the vaginal mesh exposure model. Animals were divided into 3 groups based on number and timing of exosome injection: (1) single purified exosome product (PEP) injection (acute-single), (2) weekly PEP injections (acute-weekly, 4 total injections), and (3) delayed single injection (subacute-single). Acute and subacute injections occurred 1 and 8 weeks after mesh implantation, respectively. EdU, a thymidine analog, was given twice weekly after the first injection to track tissue regeneration. Euthanasia and tissue analysis occurred 4 weeks after the first injection. ImageJ was used to quantify epithelial thickness, cellular proliferation, and capillary density. Statistical analysis was performed using analysis of variance and post hoc Tukey test. RESULTS: Acute-single PEP injection tissues mirrored pilot study results, validating replication of protocol. Within the acute groups, weekly dosing resulted in 1.5× higher epithelial thickness (nonsignificant), 1.8× higher epithelial proliferation (P < 0.05), and 1.5× higher regenerated capillary density (P < 0.05) compared with single injection. Regarding chronicity of the exposure, the subacute group showed 1.7× higher epithelial proliferation (nonsignificant) and similar capillary density and epithelial thickness as compared with the acute group. CONCLUSIONS: Exosome redosing resulted in significantly greater epithelial proliferation with significantly higher regenerated capillary density, leading to a trend toward thicker epithelium. Subacute exposure exhibited similar regeneration to acute exposure despite a delayed injection timeline. These results contribute to a growing body of preclinical research demonstrating utility of exosomes in pelvic floor disorders.
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Exossomos/metabolismo , Telas Cirúrgicas/efeitos adversos , Vagina/cirurgia , Cicatrização/efeitos dos fármacos , Animais , Feminino , Humanos , Prolapso de Órgão Pélvico/cirurgia , Slings Suburetrais , SuínosRESUMO
INTRODUCTION AND HYPOTHESIS: It is predicted that the number of women aged 80 years or older will more than triple by 2050. In the US, women have a 13% lifetime risk of undergoing pelvic organ prolapse surgery. Our aim was to compare the perioperative outcomes following various reconstructive approaches for apical prolapse surgery in the very elderly. METHODS: The National Surgical Quality Improvement Program database was used to identify women age ≥ 80 years of age who underwent reconstructive apical prolapse surgery from 2010 to 2017. Perioperative morbidity of vaginal colpopexy, minimally invasive sacrocolpopexy (MISC) and abdominal sacrocolpopexy (ASC) were compared. The primary outcome was the rate of composite serious complications. Univariate and multivariate logistic regression was used to identify independent predictors of serious complications. RESULTS: A total of 1012 patients were identified: vaginal (n = 792), MISC (n = 151) and ASC (n = 69). The composite serious complication rate was higher in the ASC group compared to vaginal/MISC groups (18.8% vs. 9.3% and 9.3%, p < 0.05). ASC had higher rates of blood transfusion, thromboembolism and reintubation. Life-threatening complications, readmission, pneumonia, stroke and 30-day mortality were lowest in the vaginal group. ASC (aOR 2.27), age > 85 years (aOR 1.98), operative time > 3 h (aOR 2.02), baseline dyspnea (aOR 2.17), "other race" (aOR 2.04), preoperative coagulopathy (aOR 2.92) and ASA (aOR 1.47) were associated with composite serious complications. CONCLUSION: ASC is associated with higher perioperative morbidity in the very elderly population. MISC and vaginal colpopexy have similar rates of composite serious complications; however, vaginal colpopexy is overall the safest approach in this population.
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Prolapso de Órgão Pélvico , Procedimentos de Cirurgia Plástica , Idoso , Idoso de 80 Anos ou mais , Feminino , Procedimentos Cirúrgicos em Ginecologia , Humanos , Prolapso de Órgão Pélvico/cirurgia , Complicações Pós-Operatórias , Estudos RetrospectivosRESUMO
STUDY OBJECTIVE: The objectives of this study were to (1) pilot a robotic console configuration methodology to optimize ergonomic posture, and (2) determine the effect of this intervention on surgeon posture and musculoskeletal discomfort. DESIGN: This was an institutional review board-approved prospective cohort study conducted from February 2017 to October 2017. SETTING: A single tertiary care midwestern academic medical center. PARTICIPANTS: Six fellowship-trained gynecologic surgeons, proficient in robotic hysterectomy, were recruited: 3 men and 3 women. INTERVENTIONS: Each surgeon performed 3 robotic hysterectomies using their self-selected robotic console settings (preintervention). Then, a robotic console ergonomic intervention protocol was implemented by trained ergonomists to improve posture and decrease time in poor ergonomic positions. Each surgeon then performed 3 robotic hysterectomies using the ergonomic intervention settings (postintervention). All surgeries used the da Vinci Xi surgical system (Intuitive Surgical, Inc., Sunnyvale, CA) and were the first case of the day. The surgeons wore inertial measurement unit (IMU) sensors on their head, chest, and bilateral upper arms during surgery. The IMU sensors are equipped with accelerometers, gyroscopes, and magnetometers to give objective measurements of body posture. IMU data were then analyzed to determine the percentage of time spent in ergonomically risky postures as categorized using a modified rapid upper limb assessment. Before and after each hysterectomy, the surgeons completed identical questionnaires for an assessment of musculoskeletal pain/discomfort. The outcome measurements were compared pre- versus postintervention on the basis of fitting generalized linear mixed models that handled the individual surgeon as a random effect and "setting" as a fixed effect. MEASUREMENTS AND MAIN RESULTS: With regard to the IMU posture results, there was a significant decrease in time spent in the moderate- to high-risk neck position and a decrease in average neck angle after the ergonomic intervention. The average percentage of time spent in moderate- to high-risk categories was significantly lower for the neck (mean, 54.3% vs 21.0%; pâ¯=â¯.008) and right upper arm (mean, 15.5% vs 0.9%; pâ¯=â¯.02) when using the intervention settings compared with the surgeons' settings. Pain score results: There were fewer reported increases in neck (4 [22%] vs 1 [6%]) and right shoulder (4 [22%] vs 2 [11%]) pain or discomfort after completion of robotic hysterectomy postintervention versus preintervention; however, these differences did not attain statistical significance (pâ¯=â¯.12 and pâ¯=â¯.37, respectively). CONCLUSION: An ergonomic robotic console intervention demonstrated effectiveness and improved objective surgeon posture at the console when compared with the surgeons' self-selected settings.
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Doenças Profissionais , Procedimentos Cirúrgicos Robóticos , Ergonomia , Feminino , Procedimentos Cirúrgicos em Ginecologia , Humanos , Masculino , Estudos ProspectivosRESUMO
OBJECTIVES: The objective of this study was to evaluate perioperative complications in women who underwent minimally invasive sacrocolpopexy (MISC) versus mesh-augmented vaginal repair (vaginal mesh) for pelvic organ prolapse. METHODS: We identified patients undergoing MISC and vaginal mesh via Current Procedural Terminology codes from the American College of Surgeons National Surgical Quality Improvement Program database from 2005 to 2016. Those undergoing concomitant hysterectomy were excluded. Univariate analyses were performed to compare baseline characteristics and 30-day complications. Multivariable logistic regression models were constructed to assess the association between surgical approach and complications, prolonged hospitalization, reoperation, and blood transfusion. A multivariable Cox proportional hazard model was used to evaluate hospital readmission. RESULTS: A total of 5722 patients were identified (2573 MISC [45%], 3149 vaginal mesh [55%]). Those undergoing MISC repairs had a significantly lower rate of urinary tract infection (3.1 vs 4.2%; P = 0.03) and blood transfusion (0.5 vs 1.4%; P < 0.001). There was no difference in reoperation rate (1.3 vs 1.6%; P = 0.35). Multivariable analysis showed no significant association of MISC with overall (odds ratio [OR], 0.91; P = 0.44), major (OR, 1.30; P = 0.31), or minor complication (OR, 0.85; P = 0.26). There were lower odds of receiving a blood transfusion (OR, 0.44; P = 0.02) and higher odds of prolonged hospitalization (>2 days; OR, 1.47; P = 0.003) for the MISC group. There was no difference in reoperation (OR, 0.79; P = 0.38) or hospital readmissions (hazard ratio, 1.25, P = 0.32). CONCLUSIONS: Minimally invasive sacrocolpopexy was associated with a lower rate of blood transfusion than transvaginal mesh placement. There was no significant difference in 30-day complication rates, reoperation, or readmission between these prolapse procedures when performed without concomitant hysterectomy.
Assuntos
Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Laparoscopia , Prolapso de Órgão Pélvico/cirurgia , Telas Cirúrgicas/efeitos adversos , Transfusão de Sangue/estatística & dados numéricos , Estudos de Coortes , Conjuntos de Dados como Assunto , Feminino , Procedimentos Cirúrgicos em Ginecologia/métodos , Humanos , Tempo de Internação/estatística & dados numéricos , Pessoa de Meia-Idade , Readmissão do Paciente/estatística & dados numéricos , Complicações Pós-Operatórias , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Infecções Urinárias/etiologiaRESUMO
INTRODUCTION AND HYPOTHESIS: Growing literature details the critical importance of the microbiome in the modulation of human health and disease including both the gastrointestinal and genitourinary systems. Rectovaginal fistulae (RVF) are notoriously difficult to manage, many requiring multiple attempts at repair before correction is achieved. RVF involves two distinct microbiome communities whose characteristics and potential interplay have not been previously characterized and may influence surgical success. METHODS: In this pilot study, rectal and vaginal samples were collected from 14 patients with RVF. Samples were collected preoperatively, immediately following surgery, 6-8 weeks postoperatively and at the time of any fistula recurrence. Amplification of the 16S rDNA V3-V5 gene region was done to identify microbiota. Data were summarized using both α-diversity to describe species richness and evenness and ß-diversity to characterize the shared variation between communities. Differential abundance analysis was performed to identify microbial taxa associated with recurrence. RESULTS: The rectal and vaginal microbiome in patients undergoing successful fistula repair was different than in those with recurrence (ß-diversity, p = 0.005 and 0.018, respectively) and was characterized by higher species diversity (α-diversity, p = 0.07 and p = 0.006, respectively). Thirty-one taxa were enriched in patients undergoing successful repair to include Bacteroidetes, Alistipes and Rikenellaceae as well as Firmicutes, Subdoligranulum, Ruminococcaceae UCG-010 and NK4A214 group. CONCLUSIONS: Microbiome characteristics associated with fistula recurrence have been identified. The association of higher vaginal diversity with a favorable outcome has not been previously described. Expansion of this pilot project is needed to confirm findings. Taxa associated with successful repair could be targeted for subsequent therapeutic intervention.
Assuntos
Microbiota , Fístula Retovaginal , Feminino , Humanos , Projetos Piloto , Fístula Retovaginal/cirurgia , RetoRESUMO
OBJECTIVE: To compare the perioperative outcomes of transvaginal/perineal and abdominal approaches to rectovaginal fistula (RVF) repair using a national multicenter cohort. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was utilized to identify women undergoing RVF repair from 2005 to 2016. Emergent cases and those with concomitant bowel diversion were excluded. Baseline patient demographics, procedure characteristics, 30-day postoperative complications, return to the operating room, and readmission were evaluated. Baseline characteristics were compared across surgical approach. Multivariable logistic regression models identified preoperative characteristics independently associated with postoperative complications. RESULTS: A total of 2288 women underwent RVF repair: 1560 (68.2%) via transvaginal/perineal approach and 728 (31.8%) via abdominal approach. Patients undergoing transvaginal/perineal repair were significantly younger (median age, 46 years vs 63 years), with lower American Society for Anesthesiologist (ASA) scores, and less frequency of diabetes mellitus, dyspnea, severe chronic obstructive pulmonary disease, hypertension, disseminated cancer, and bleeding disorders (all P < 0.01). Those undergoing abdominal repair had higher rates of major complications (25.8% vs 8.7%), minor complications (13.5% vs 6.3%), and readmission (13.2% vs 7.8%). On multivariable analyses, ASA Class 3/4, disseminated cancer, and hematocrit <30% (P < 0.01) were associated with major complications in both groups. CONCLUSIONS: Patients undergoing RVF repair via abdominal approach were older with more comorbidities and had higher postoperative complications rates, likely secondary to underlying differences in the treated populations. Irrespective of surgical approach, ASA class, disseminated cancer, and preoperative anemia were associated with higher postoperative morbidity. This may enhance preoperative counseling and allow for careful patient selection.
Assuntos
Procedimentos Cirúrgicos em Ginecologia/métodos , Fístula Retovaginal/cirurgia , Abdome/cirurgia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Bases de Dados Factuais , Feminino , Humanos , Modelos Logísticos , Pessoa de Meia-Idade , Análise Multivariada , Readmissão do Paciente/estatística & dados numéricos , Períneo/cirurgia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Resultado do Tratamento , Vagina/cirurgia , Adulto JovemRESUMO
OBJECTIVE: To describe the unique presentation and surgical management of a complete uterovaginal septum. DESIGN: Video case report. SETTING: Tertiary care academic medical center. PATIENT(S): A 25-year-old woman, gravida 2, para 0-0-2-0, referred for evaluation after imaging and clinical examination revealed conflicting information. She was initially seen by her local provider for menorrhagia. Locally an ultrasound revealed a septate uterus, and examination under anesthesia with hysteroscopy noted a single vagina and cervix with a unicornuate uterus. Due to incongruous findings, she was referred for evaluation. INTERVENTION(S): Magnetic resonance imaging (MRI), examination under anesthesia, vaginal surgery, and operative hysteroscopy. MAIN OUTCOMES AND MEASURE(S): The MRI identified a complete uterovaginal septum with a single septate cervix. Vaginal gel was used to define vaginal anatomy, and the gel was noted to fill the right hemivagina with none noted on the left. Examination under anesthesia revealed an imperforate hymen with a small opening on the left as the cause for confusion in the clinical presentation. A hymenectomy was performed followed by guided surgical management of a complete uterovaginal septum, unicollis. RESULT(S): The patient was discharged home the same day of surgery. CONCLUSION(S): Presentation of müllerian anomalies are often complex, and anatomic variations in commonly described anomalies make misdiagnoses common. Advanced imaging with use of MRI with vaginal gel or three-dimensional ultrasonography and detailed examination are often helpful. Differentiating between unicollis and bicollis presentations in complete uterovaginal septum cases is an important distinction during surgical management.