A Bayesian nonparametric model for classification of longitudinal profiles.

Across several medical fields, developing an approach for disease classification is an important challenge. The usual procedure is to fit a model for the longitudinal response in the healthy population, a different model for the longitudinal response in the diseased population, and then apply Bayes' theorem to obtain disease probabilities given the responses. Unfortunately, when substantial heterogeneity exists within each population, this type of Bayes classification may perform poorly. In this article, we develop a new approach by fitting a Bayesian nonparametric model for the joint outcome of disease status and longitudinal response, and then we perform classification through the clustering induced by the Dirichlet process. This approach is highly flexible and allows for multiple subpopulations of healthy, diseased, and possibly mixed membership. In addition, we introduce an Markov chain Monte Carlo sampling scheme that facilitates the assessment of the inference and prediction capabilities of our model. Finally, we demonstrate the method by predicting pregnancy outcomes using longitudinal profiles on the human chorionic gonadotropin beta subunit hormone levels in a sample of Chilean women being treated with assisted reproductive therapy.

Systemic adiponectin levels in colorectal cancer and adenoma: a systematic review and meta-analysis.

BACKGROUND: Obesity is a well-established risk factor in the development of colorectal cancer; however, the mechanism mediating this relationship is not well understood. The adipokine, adiponectin, has an inverse relationship with obesity. Experimental studies have shown adiponectin to have dichotomous inflammatory and tumorigenic roles. Its role in the development of colorectal cancer, including the potential effect of its increase following bariatric surgery, is not yet clear. There are conflicting results from studies evaluating this relationship. This study sought to provide a systematic review and meta-analysis to examine the association between systemic adiponectin levels in patients with colorectal cancer and adenoma. METHODS: An electronic literature search was performed using PubMed, EMBASE, Web of Science as well as gray literature. Articles were screened for inclusion criteria and assessed for quality using the Newcastle-Ottawa Scale. Pooled mean differences were calculated using a random effects model. Subgroup and meta-regression analyses were performed to identify potential sources of heterogeneity. RESULTS: Thirty-two observational studies comparing systemic adiponectin in colorectal cancer vs healthy controls were included. Colorectal cancer cases had lower systemic adiponectin levels (overall pooled mean difference = -1.05 µg/ml [95% CI: -1.99; -0.12] p = 0.03); however, significant heterogeneity was present (I2 = 95% p < 0.01). Subgroup and meta- regression analyses results could not identify a source of the significant heterogeneity across the studies. CONCLUSIONS: Studies suggest a trend towards lower systemic adiponectin levels in colorectal cancer patients, but the heterogeneity observed showed current evidence is not sufficient to definitively draw any conclusions. These data, however, suggest rising adiponectin is unlikely to account for the reported observation of increased CRC following bariatric surgery. Further studies with prospective age, race, and BMI-matched cohorts, and standardized adiponectin measurements may provide a better understanding of this relationship.

Proximity of percutaneous tibial nerve stimulation needle insertion to surrounding anatomic structures: a cadaveric study.

BACKGROUND: Percutaneous tibial nerve stimulation is a third-line treatment for overactive bladder and urgency urinary incontinence. During the procedure, a needle is inserted cephalad to the medial malleolus and posterior to the tibia. In recent years, permanent implants and leads have been developed for insertion into the medial ankle via a small incision. There are many important structures present in the medial compartment of the ankle, including the great saphenous vein, saphenous nerve, tibial nerve, posterior tibial vessels, and tendons of the posterior compartment leg muscles. OBJECTIVE: The primary objective of this study was to identify the proximity of the percutaneous tibial nerve stimulation needle placed per Food and Drug Administration-approved device instructions to nearby important anatomic structures. The secondary objectives were to identify the proximity of the tibial nerve to the needle site, identify clinically relevant ankle anatomic structures, and confirm the tibial nerve and posterior tibial vasculature by histologic analysis. STUDY DESIGN: Detailed medial ankle dissections were performed bilaterally on 10 female lightly embalmed anatomic donors (cadavers) obtained from the Willed Body Program at the University of Louisville. A pin was inserted at the percutaneous tibial nerve stimulation needle site, and the medial ankle was minimally dissected so the surrounding anatomic structures were visible but not disrupted. The shortest distance from the pin to the selected structures of the medial ankle region was measured. On completion of each dissection and set of measurements, tissue was harvested for histologic examination. The distances between the pin and each structure were assessed using means and standard deviations. A paired t test was used to assess the difference in the locations between the left and right ankles. Statistical analysis was performed on left-sided, right-sided, and combined measurements. An 80% prediction interval was found to represent the expected range of values for the measurement of a new cadaver or patient, and the 95% confidence interval of the mean was computed to characterize the average distance across all cadavers or patients. RESULTS: The medial ankle of 10 adult female lightly embalmed cadavers were examined bilaterally. Dissections were completed from October 2021 to July 2022. Of note, 80% prediction intervals for the tibial nerve, the posterior tibial artery or vein, and the flexor digitorum longus tendon had a lower range of 0.0 mm from the pin and extending to 12.1, 9.5, and 13.9 mm, respectively. Moreover, 2 of the structures were found to be asymmetrical between the right and left ankles. The great saphenous vein was further from the pin on the left (20.5 mm [standard deviation of 6.4 mm] on the left vs 18.1 mm [standard deviation of 5.3 mm] on the right; P=.04). The calcaneal (Achilles) tendon was further from the pin on the right side (13.2 mm [standard deviation of 6.8 mm] vs 7.9 mm [standard deviation of 6.7 mm]; P=.04). Tibial neurovascular structures were confirmed with microscopic analysis. CONCLUSION: The anatomic structures within the medial ankle lie unexpectedly close to the percutaneous tibial nerve stimulation needle site as noted per Food and Drug Administration-approved device instructions. There is a possibility that some medial ankle structures are not symmetrical. It is crucial that practitioners understand medial ankle anatomy when performing percutaneous tibial nerve stimulation or permanent device insertion.

A Bayesian hierarchical sparse factor model for estimating simultaneous covariance matrices for gestational outcomes in consecutive pregnancies.

Covariance estimation for multiple groups is a key feature for drawing inference from a heterogeneous population. One should seek to share information about common features in the dependence structures across the various groups. In this paper, we introduce a novel approach for estimating the covariance matrices for multiple groups using a hierarchical latent factor model that shrinks the factor loadings across groups toward a global value. Using a sparse spike and slab model on these loading coefficients allows for a sparse formulation of our model. Parameter estimation is accomplished through a Markov chain Monte Carlo scheme, and a model selection approach is used to select the number of factors to use. We validate our model through extensive simulation studies. Finally, we apply our methodology to the NICHD Consecutive Pregnancies Study to estimate the correlations between birth weights and gestational ages of three consecutive birth within four different subgroups (underweight, normal, overweight, and obese) of women.

[S156] Comparing outcomes of per-oral pyloromyotomy and robotic pyloroplasty for the treatment of gastroparesis.

BACKGROUND: Gastroparesis is characterized by delayed gastric emptying without a significant obstructive pathology and is estimated to effect more than 5 million adults in the United States. Therapies for this condition are divided into two categories: gastric electrical stimulation or pyloric therapies to facilitate gastric emptying. Pyloric procedures include pyloroplasty, a well-documented procedure, and per-oral endoscopic myotomy (POP), a relatively novel endoscopic procedure that disrupts the pyloric muscles endoscopically. There is a paucity of literature comparing the two procedures. The aim of this study is to compare the outcomes of these two techniques. METHODS: Under an IRB protocol, data were collected prospectively from September 2018 through April 2021 at our institution for patients undergoing POP (n = 63 patients) or robotic pyloroplasty (RP) (n = 48). Preoperative and postoperative data including sex, race, age, BMI, and Gastroparesis Cardinal Symptom Index (GCSI) score were analyzed using univariate and multivariate analysis. RESULTS: There was no significant difference in sex, age, and BMI for both cohorts, but patients with RP were more likely to have private insurance, pre-op reflux, and PPI (p < .05 for all). Patients who underwent POP had significantly shorter operative time compared to RP (median 27 min vs 90, p < 0.001). The average change between preoperative and postoperative GCSI scores was significantly decreased for both interventions (POP mean = 8.2, RP 16.8, p < 0.001 both). However, comparing both data, RP has significantly better improvement in postoperative GCSI score than POP in both univariate (p < 0.001) and multivariate analysis (p = 0.030). This was reflected in the individual symptoms with nausea (p < 0.001), ability to finish meal (p = 0.037), abdomen visibly larger (p = 0.037) and bloating (p = 0.022) all showing improvement in both groups, but with RP having a more significant decrease in the scoring of these symptoms than POP. There was no significant difference in the number of postoperative complications (POP 19% vs RP 13%, p = 0.440). CONCLUSION: Even though both interventions are significantly associated with improvement of symptoms in patients with gastroparesis, our data demonstrates that robotic pyloroplasty has a superior response in comparison to per-oral endoscopic myotomy for the management of these symptoms. Per-oral pyloromyotomy has a similar complication rate to robotic pyloroplasty with a shorter operative time.

General anesthesia versus regional anesthesia in patients undergoing obliterative vaginal procedures for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The objective was to compare outcomes in patients receiving general versus regional anesthesia when undergoing obliterative vaginal surgery for pelvic organ prolapse. METHODS: Obliterative vaginal procedures performed from 2010 to 2020 were identified in the American College of Surgeons National Surgical Quality Improvement Program database using Current Procedural Terminology codes. Surgeries were categorized into general anesthesia (GA) or regional anesthesia (RA). Rates of reoperation, readmission, operative time, and length of stay were determined. A composite adverse outcome was calculated including any of the following: nonserious or serious adverse events, 30-day readmission, or reoperation. Propensity score-weighted analysis of perioperative outcomes was performed. RESULTS: The cohort included 6,951 patients, of whom 6,537 (94%) underwent obliterative vaginal surgery under GA and 414 (6%) received RA. When comparing outcomes under the propensity score-weighted analysis, operative times were shorter (median 96 vs 104 min, p<0.01) in the RA group versus GA. There were no significant differences between composite adverse outcomes (10% vs 12%, p=0.06), or readmission (5% vs 5%, p=0.83) and reoperation rates (1% vs 2%, p=0.12) between the RA and GA groups. Length of stay was shorter in patients receiving GA than in those receiving RA, especially when undergoing concomitant hysterectomy (67% discharged within 1 day in GA vs 45% in RA, p<0.01). CONCLUSIONS: Composite adverse outcomes, reoperation rates, and readmission rates were similar in patients who received RA for obliterative vaginal procedures compared with GA. Operative times were shorter in patients receiving RA than in those receiving GA, and length of stay was shorter in patients receiving GA than in those receiving RA.

A meta-analysis and systematic review of the comparison of laparoscopic ablation to percutaneous ablation for hepatic malignancies.

BACKGROUND: The optimal access for thermal ablation of the liver has not been evaluated in the literature for the laparoscopic versus percutaneous techniques. The aim of this manuscript was to determine the optimal ablation technique and patient selection for hepatic malignancies by comparing the efficacy and recurrence-free survival of laparoscopic and percutaneous thermal ablation. METHODS: A detailed literature search was made in PubMed, Web of Science, Google scholar, and EMBASE for related research publications. The data were extracted and assessed by two reviewers independently. Analysis of pooled data was performed, and Odds Ratio (OR) or Hazard Ratio (HR) with corresponding confidence intervals (CIs) was calculated and summarized respectively. RESULTS: A total of 10 articles were included with 1916 ablation patients. Laparoscopic ablation success (Median 100%) was found to be higher than percutaneous ablation success (median 89.4%) (p = ns). There was a higher percentage of both local and non-local hepatic recurrence in the patients treated with percutaneous ablation versus laparoscopic ablation. Meta-analysis indicated no difference in the adjusted hazard rate of recurrence by procedure type (p = 0.94). Laparoscopic ablation had a higher percentage of complications compared to percutaneous ablation (median lap 14.5% vs. perc 3.3%). CONCLUSIONS: While laparoscopic and percutaneous ablation are both effective interventions for hepatic malignancies, laparoscopic ablation was found to have improved ablation success and less local and non-local hepatic recurrence compared to percutaneous ablation.

Patterns of care and outcomes of radiotherapy or hormone therapy in patients with medically inoperable endometrial adenocarcinoma.

OBJECTIVE: The optimal treatment for medically inoperable endometrioid endometrial adenocarcinoma is unknown. The goal of this study was to evaluate the patterns of care and efficacy of radiotherapy (RT) or hormone therapy (HT) in the treatment of these patients. METHODS: We performed a query of the National Cancer Database (NCDB) of patients with medically inoperable endometrioid adenocarcinoma of the endometrium diagnosed between 2004 and 2016 and treated with either RT or HT. A multivariate Cox regression model and propensity weighted analyses were used to evaluate overall survival after controlling for confounding variables. A multinomial logistic regression model was used to assess predictors of RT or HT use. RESULTS: A total of 1036 patients were included in this cohort, and 73% (n = 759) were treated with RT alone. Patients who received definitive HT compared to RT were more likely to be older, diagnosed in the earlier years of this analysis, treated at lower-case volume centers, diagnosed with high-grade disease, or located outside of metropolitan areas. On multivariate analysis, treatment with HT alone versus RT alone was associated with significantly worse overall survival in the multivariate Cox model but not on propensity score weighted analysis. Interaction effect testing revealed that older patients and those treated at lower-volume centers had improved survival with RT compared to HT. CONCLUSIONS: We identified factors associated with the receipt of RT or HT in medically inoperable endometrial cancer patients. Treatment with RT correlated with improved survival compared to HT in older patients and those treated at lower-volume centers.

Role of adjuvant chemotherapy in patients with FIGO stage IB grade 3 endometrial endometrioid adenocarcinoma treated with surgery and post-operative radiotherapy.

BACKGROUND: The optimal treatment of patients with FIGO stage IB grade 3 endometrial endometrioid adenocarcinoma remains unknown. OBJECTIVE: To compare overall survival following treatment with a hysterectomy and adjuvant radiotherapy with or without chemotherapy in this group of patients. METHODS: Patients diagnosed between January 2004 and January 2016 with FIGO stage IB grade 3 endometrial endometrioid adenocarcinoma treated with hysterectomy and postoperative radiotherapy with or without adjuvant concurrent chemotherapy were identified in the National Cancer Database. Overall survival was assessed with Kaplan-Meier curves. A Cox model was constructed to evaluate survival after controlling for confounding variables. A logistic regression model was used to reveal predictors of chemotherapy use. RESULTS: A total of 2173 patients were included. The receipt of chemotherapy was associated with an increased 5-year overall survival from 67.6% to 75.6% (p=0.0313). This association trended toward statistical significance on multivariate analysis (adjusted HR (aHR) 0.80; 95% CI 0.63 to 1.01; p=0.0653). Other factors associated with improved survival were undergoing a lymphadenectomy, absence of lymphovascular space invasion, younger age, smaller tumor size, non-black race, and absence of comorbidities. Patients who underwent brachytherapy, had lymphovascular space invasion, were younger, were diagnosed in the more recent years, and were treated in higher volume centers were more likely to receive adjuvant chemotherapy. CONCLUSION: Adjuvant chemotherapy and radiation therapy were associated with an increase in survival in patients with FIGO stage IB grade 3 endometrial endometrioid adenocarcinoma compared with those treated with adjuvant radiotherapy alone.

Trends in Incidence and Mortality Rates of Uterine Cancer in Kentucky.

OBJECTIVES: The objective of this analysis was to gauge how the incidence and mortality of uterine cancer in Kentucky have changed from 1995 through 2017. An assessment of the trends in incidence and mortality across different geographic areas and between different races was also performed. METHODS: Age-adjusted annual incidence and mortality rates for uterine cancer were obtained from the Kentucky Cancer Registry. A meta-regression framework was used to assess changes in incidence and mortality rates during the time frame and to determine differences in these rates between rural versus urban counties, Appalachian versus non-Appalachian counties, and Black versus White women. RESULTS: The incidence of uterine cancer has significantly increased throughout the state of Kentucky since 1995. Uterine cancer incidence was 10% and 22% higher in rural and Appalachian counties, respectively, compared with urban and non-Appalachian counties (P < 0.0001) from 1995 through 2017. In contrast, urban and non-Appalachian women had higher or equivalent age-adjusted mortality from uterine cancer, compared with rural and Appalachian women, respectively. The incidence of uterine cancer was significantly higher in White women compared with Black women from 1995 through 2006, but since 2007, there has been no significant difference in uterine cancer incidence based on race. Black women had higher age-adjusted mortality than White women throughout the entire time period examined. CONCLUSIONS: The incidence of uterine cancer is higher in rural and Appalachian Kentucky, without a corresponding geographic trend in mortality. Uterine cancer mortality is significantly higher in Black women.

Comparative analyses of attitude, knowledge, and recollection of preoperative counseling regarding pelvic mesh among women with or without a mesh-related complication.

PURPOSE: Our objective was to compare the recollection of preoperative counseling regarding mesh for pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI) among women with or without a mesh-related complication (MRC). We hypothesized that the patients who had MRC would better recollect counseling regarding complications associated with mesh. METHODS: We conducted a retrospective cohort study among women who had prior implantation of synthetic, non-absorbable mesh for POP and/or SUI at least 3 months prior who presented with or without a MRC. The primary outcome was the proportion of women who recalled being counseled preoperatively about the risk of mesh exposure. RESULTS: Ninety-six women were included in the final analysis (50 MRC; 46 no MRC). MRC women presented further in time from the index surgery [median 69 months [IQR 26-115] vs 12 months (IQR 6-64), p < 0.01]. After adjustment for time since surgery and age, MRC women were significantly less likely to recall being counseled about the possibility of any MRC [19/50 (38%) vs 32/44 (73%), aOR 0.29, 95% CI 0.11-0.79, p = 0.01]. They were also less likely to report they would undergo the same surgery again 5-point Likert scale [median 3 (IQR 1-4) vs 5 (IQR 3-5), 5-point Likert scale, p < 0.01], less satisfied with their mesh surgery [median 1 (IQR 1-3) vs 5 (IQR 3-5), 5-point Likert scale, p < 0.01] and recommended improved preoperative counseling [27/50 (54%) vs 6/46 (13%), p < 0.01]. CONCLUSION: Women who experienced MRC were less likely to recall being counseled about the possibility of MRC and report more unmet needs regarding perioperative counseling than women without MRC.

Surface mould brachytherapy in oral and oropharyngeal cancers.

INTRODUCTION: There are insufficient data on surface mold brachytherapy (SMB) in treating oral cancers. We reviewed our institutional experience to investigate the efficacy and toxicity of this treatment modality. MATERIAL AND METHODS: We retrospectively reviewed all the patients treated between 1989 and 2018 with high-dose-rate iridium-192 SMB for oral and oropharyngeal squamous cell carcinomas at our institution. Surface mold brachytherapy was delivered via an acrylic surface mold with 1-5 inserted catheters spaced 1 cm apart fabricated by our dental oncologist. The Kaplan-Meier product estimator was used to assess local control (LC), locoregional control (LRC), distant metastasis-free survival (DMFS), and overall survival (OS). Cox proportional hazards regression analysis was used to assess the relationship of various variables and patient outcomes. RESULTS: Eighteen patients met the inclusion criteria and were evaluated. Indications for treatment were primary tumor (n = 13), local recurrence (2), locoregional recurrence (1), and oligometastatic disease (1). Ten patients received SMB alone and 8 received external beam radiotherapy with an SMB boost. The acute toxicity outcomes were as follows: no toxicity (n = 1), grade 1 (7), grade 2 (9), and grade 3 (1). Late effects were rare, only occurring in 3 patients. The one- and two-year LC were 81% and 68%, LRC 77% and 64%, DMFS 81% and 81%, and OS 77% and 46%. CONCLUSIONS: Surface mold brachytherapy is a viable modality as either primary or boost treatment for superficial oral cancers. In our patients, this treatment method has a low toxicity profile and resulted in reasonable LC.

Stereotactic body radiation therapy (SBRT) of adrenal gland metastases in oligometastatic and oligoprogressive disease.

BACKGROUND: Stereotactic body radiation therapy (SBRT) as a form of noninvasive treatment that is becoming increasingly used to manage cancers with adrenal gland metastases. There is a paucity of data on safety and efficacy of this modality. The aim of the study was to evaluate the safety and efficacy of adrenal gland SBRT in oligometastatic and oligoprogressive disease. MATERIALS AND METHODS: In this retrospective study, we performed a single-institution analysis of 26 adrenal lesions from 23 patients with oligometastatic or oligoprogressive disease treated from 2013 to 2019 with the goal of achieving durable local control. Palliative cases were excluded. Radiation dosimetry data was collected. Kaplan Meier product estimator and Cox proportional hazards regression analysis were used for statistical analysis. RESULTS: The median dose was 36 Gy in 3 fractions (range: 24-50 Gy and 3-6 fractions) with a median biologically effective dose (BED10) of 72 (range: 40-100). 1-year local control rate was 80% and median local control was not achieved due to a low number of failures. 1- and 2-year overall survival rates were 66% and 32%. Toxicity was mild with only one case of grade 2 nausea and no grade 3-5 toxicity. Higher neutrophil to lymphocyte ratio was associated with worse overall survival and a trend toward worse progression-free survival. In addition, worse performance status and lower BED10 were associated with worse survival. No such association could be shown for primary tumor location, histology, size or stage. CONCLUSION: Adrenal SBRT for oligometastatic or oligoprogressive disease is a safe and effective form of treatment.

Cervical cancer incidence and mortality rates in Kentucky.

OBJECTIVES: The goal of this study was to assess how the incidence and mortality of cervical cancer in Kentucky has changed from 1995 through 2017. Additionally, trends in incidence and mortality across different geographic areas and between different races were evaluated. METHODS: Age-adjusted annual incidence and mortality rates for cervical cancer were collected from the Kentucky Cancer Registry (KCR). A quadratic fit model was used to evaluate changes in the incidence and mortality over time and to compare differences in cervical cancer incidence and mortality by: 1) rural versus urban counties, 2) Appalachian versus non-Appalachian counties, and 3) black versus white women. RESULTS: Overall, the incidence of cervical cancer has significantly decreased throughout Kentucky since 1995. When comparing different geographic regions, the incidence was 14% and 23% higher in rural and Appalachian counties, respectively, compared to urban and non-Appalachian counties (p < 0.0001) throughout the study period. The incidence of cervical cancer was significantly higher in black women compared to white women from 1995 through 2007, but since 2008 there has been no significant difference in cervical cancer incidence based on race. Similar to incidence rates, mortality from cervical cancer was 29% higher in Appalachia (p = 0.0004) throughout the studied time period. Black women had higher age-adjusted mortality than white women until 2012, but since that time there has not been a significant difference in cervical cancer mortality based on race. CONCLUSIONS: Women residing in rural and Appalachian Kentucky have higher cervical cancer incidence and mortality rates.

Development of a safety zone for rectus abdominis fascia graft harvest based on dissections of the ilioinguinal and iliohypogastric nerves.

BACKGROUND: As a result of the vaginal mesh controversy, surgeons are performing more nonmesh, autologous fascia pubovaginal slings to treat stress urinary incontinence in women. The rectus abdominis fascia is the most commonly harvested site for autologous pubovaginal slings, so it is crucial that surgeons are familiar with the relationship between this graft harvest site and the ilioinguinal and iliohypogastric nerves, which can be injured during this procedure. OBJECTIVE: The aims of this study were as follows: (1) to estimate the safest area between the bilateral courses of the ilioinguinal and iliohypogastric nerves in which a rectus abdominis fascia graft could be harvested with minimal risk of injury to these nerves and (2) to determine the location and dimensions of a graft harvest site that maximized graft length while remaining close to the pubic symphysis. STUDY DESIGN: The ilioinguinal and iliohypogastric nerves were dissected bilaterally in 12 unembalmed female anatomical donors. The distances of these nerves to a 10 × 2 cm rectus abdominis fascia graft site located 4 cm above the pubic symphysis were measured. Nerve courses inferior to the graft site were determined for each donor by linearly extrapolating measurement points; analysis was performed with and without extrapolation. Average nerve trajectories were estimated assuming a linear regression function to predict the horizontal measurement as a quadratic function of the vertical distance; 95% confidence bands were also estimated. An estimated safety zone was determined to be the region between all credible nerve bounds. RESULTS: The largest safety zone that was closest to the pubic symphysis was located at 5.4 cm superior to the pubic symphysis. At this location, the inferior border of the graft could measure 9.4 cm in length (4.7 cm bilaterally from the midline). Extrapolated nerve courses below the study graft site yielded a smaller safety zone located 2.7 cm superior to the pubic symphysis, allowing for the inferior border of the graft to be 4.8 cm (2.4 cm bilaterally from the midline). CONCLUSION: A rectus abdominis fascia graft harvested 5.4 cm superior to the pubic symphysis with the inferior border of the graft measuring 9.4 cm in length should minimize injury to the ilioinguinal and iliohypogastric nerves. These dimensions allow for the longest graft while remaining relatively close to the pubic symphysis. The closer a graft is harvested to the pubic symphysis, the smaller in length the graft must be to avoid injury to the ilioinguinal and iliohypogastric nerves.

The effect of omission of adjuvant radiotherapy after neoadjuvant chemotherapy and breast conserving surgery with a pathologic complete response.

OBJECTIVE(S): Neoadjuvant chemotherapy (NAC) is a standard of care for locally advanced breast cancers. Adjuvant radiotherapy (RT) after NAC is an area of active research. We hypothesize overall survival (OS) is not altered by omitting RT in women with a pathologic complete response (pCR) to NAC after breast conserving survery (BCS). METHODS: Patients from the National Cancer Database who underwent NAC, BCS, and had a pCR were included. Inflammatory disease, <6 months follow up, and unknown variables were excluded. Descriptive statistics characterized the retained cohort. Logistic regression analyzed the influence of variables on the rate of RT omission. Cox proportional hazard modeling analyzed the influence of prognostic variables on OS. RESULTS: Of 5383 women included, 364 (7%) omitted RT. 5-year OS was 94.1% with RT, 93% without. RT omission was most likely in women >70yo (adjusted OR2.4, 95%CI 1.58-3.65, p < .0001;reference 40-49 yo), Hispanic (AOR 1.73, 95%CI 1.19-2.52, p = .0044; reference non-Hispanic), ≥20 miles from treatment facility (20-49 miles; AOR 1.45, 95%CI 1.09-1.93, p = .0109: >50 miles; AOR 2.02, 95%CI 1.42-2.87, p < .0001;reference 0-19 miles), grade 1 (AOR 4.29, 95%CI 2.16-8.51, p < .0001; reference grade 3), and clinical T4 disease (AOR 3.17, 95%CI 1.74-5.79, p = .0002; reference T0/1). Women ≥60yo (60-69: AHR 2.33, 95%CI 1.41-3.83, p = .0009:70+:AHR 2.4, 95%CI 1.24-4.62, p = .0092; reference 40-49) and with N1 and N3 disease (N1: AHR 1.67, 95% CI 2.28-3.24, p = .0034; N3: AHR3.37,95%CI2.01-5.65,p < .0001) showed increased death. Triple-positive (AHR 0.18, 95%CI 0.07-0.43, p = .0002) and HER2+ patients (AHR 0.44, 95%CI 0.30-0.64, p < .0001) had improved OS compared to triple-negative disease. No survival difference was seen with omission of RT (log-rank test: p = .1783; Cox model AHR 1.33, 95%CI 0.76-2.31, p = .3181). CONCLUSION: Women ≥70, of Hispanic origin, living ≥20 miles from treatment facility, and grade 1 disease were more likely to omit RT. HER2+ patients had favorable OS, while older age and N3 disease were negative prognostic factors. Omitting RT after a pCR to NAC and BCS was not found to affect OS.

The Impact of Fluoroscopy During Percutaneous Nerve Evaluation on Subsequent Implantation of a Sacral Neuromodulator Among Women With Pelvic Floor Disorders: A Randomized, Noninferiority Trial.

OBJECTIVES: To evaluate whether percutaneous nerve evaluation (PNE) without fluoroscopy is inferior to fluoroscopy use in women undergoing trials of sacral neuromodulation (SNM) for pelvic floor disorders (PFDs). MATERIALS AND METHODS: In an unblinded noninferiority trial, women undergoing PNE were randomized to fluoroscopy or no fluoroscopy. The primary outcome was "success" and defined as implantation of the permanent SNM device within three months of PNE. At an expected 40% success and a 30% noninferiority threshold, 33 participants in each group were needed for 80% power (α = 0.05). Univariate analyses and a logistic regression model adjusting for univariate variables associated with the primary outcome were performed. RESULTS: From April 2016 to December 2018, 74 participants underwent PNE of which 36 underwent PNE with fluoroscopy and 38 without. The fluoroscopy group had less baseline mean daily voids compared to the no fluoroscopy group (10.79 ± 6.48 vs. 16.21 ± 10.05, p = 0.01). PNE performed without fluoroscopy had similar success (18/38, 47.4%) compared to fluoroscopy (21/36, 58.3%), meeting our noninferiority definition (difference 10.9%, 90% CI -8% to 30%, p = 0.049). In a logistic regression model adjusting for age, Charlson comorbidity index, stage of prolapse, and number of baseline voids per day, trial success was still similar between the two groups (adjOR 1.82, 95% CI 0.52 to 6.94, p = 0.36). CONCLUSIONS: PNE performed without fluoroscopy is noninferior to PNE with fluoroscopy use for the outcome of SNM device implantation within three months among women undergoing therapy for PFDs.

Trends and Complications of Vulvar Reconstruction After Vulvectomy: A Study of a Nationwide Cohort.

OBJECTIVES: The objective of this study was to determine complications associated with primary closure compared with reconstruction after vulvar excision and predisposing factors to these complications. METHODS: Patients undergoing vulvar excision with or without reconstruction from 2011 to 2015 were abstracted from the National Surgical Quality Improvement Program database. Common Procedural Terminology codes were used to characterize surgical procedures as vulvar excision alone or vulvar excision with reconstruction. Patient characteristics and 30-day outcomes were used to compare the 2 procedures. Descriptive and univariate statistics were performed. Adjusted odds ratios and confidence intervals were calculated using a logistic regression model to control for potential confounders. Two-sided α with P < 0.05 was designated as significant. RESULTS: A total of 2698 patients were identified; 78 (2.9%) underwent reconstruction. There were no differences in age, race, body mass index, diabetes, hypertension, tobacco use, heart failure, renal failure, or functional status between the 2 groups. American Society of Anesthesiologists class 3 and 4 patients and those with disseminated cancer were more likely to undergo reconstruction (both P < 0.001). On univariate analysis, reconstruction was associated with increased risk of readmission, surgical site infection, pulmonary complications, urinary tract infection, transfusion, deep venous thrombosis, sepsis, septic shock, unplanned reoperation, longer hospital stay, need for skilled nursing or subacute rehab on discharge, and death within 30 days. On logistic regression analysis, disseminated cancer, American Society of Anesthesiologists classes 3 and 4 and reconstruction remained significant risk factors for readmission and any postoperative complication. CONCLUSIONS: Patients undergoing vulvar excision with reconstruction are at increased risk for readmission and postoperative complications compared with those undergoing excision alone. Careful patient selection and efforts to optimize surgical readiness are needed to improve outcomes. Long-term data could help determine if these 30-day outcomes are a reliable measure of surgical quality in vulvar surgery.

Use of an iPad™ application in preoperative counseling for pelvic reconstructive surgery: a randomized trial.

INTRODUCTION AND HYPOTHESIS: The goal of this study was to evaluate whether the addition of an iPad™ application to the informed consent process for pelvic organ prolapse (POP) surgery improves patient understanding and retention of information compared with standard verbal counseling (SVC) alone. METHODS: Patients scheduled for POP surgery were randomized to SVC alone or SVC augmented with an iPad™ application. Prior to counseling, immediately following counseling, and 6 weeks after surgery, patients completed a written quiz testing their understanding of POP and surgical repair (worst score 0; best score 20). Primary outcome was score change from pre- to immediately postcounseling. Secondary outcomes were patient satisfaction and score change from postcounseling to 6 weeks after surgery. Twenty-six patients per group were needed to detect a 2.8-point difference in score change between groups (80% power; α = 0.05). RESULTS: Sixty patients were randomized, and 57 patients (29 SVC; 28 iPad) were included in the final analysis. There was no significant difference in score change between groups immediately postcounseling. Six weeks after surgery, patients in the iPad group had more deterioration of score (iPad -4.0 ± 2.8 vs. SVC -0.6 ± 2.3 points; p = 0.02). Both groups reported similar satisfaction with counseling. CONCLUSIONS: The addition of a POP-based iPad™ application to the informed consent process for POP surgery did not improve patient comprehension immediately postcounseling and resulted in poorer retention of information 6 weeks after surgery compared with SVC alone.

Current practice patterns and knowledge among gynecologic surgeons of InterStim® programming after implantation.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to describe surgeons' current practices in InterStim® programming after initial implantation and their knowledge of programming parameters. We hypothesized that surgeons performing their own reprogramming would have increased knowledge. METHODS: We administered a written survey to attendees at the Society of Gynecologic Surgeons Scientific Meeting and analyzed those on which surgeons indicated they offer InterStim® care. The survey queried surgeon characteristics, experience with InterStim® implantation and programming, and clinical opinions regarding reprogramming and tested six knowledge-based questions about programming parameters. Correct response to all six questions was the primary outcome. RESULTS: One hundred and thirty-five of 407 (33%) attendees returned the survey, of which 99 met inclusion criteria. Most respondents (88 of 99; 89%) were between 36 and 60 years, 27 (73%) were women, 76 (77%) practiced in a university setting, and 76 (77%) were trained in Female Pelvic Medicine and Reconstructive Surgery (FPMRS). Surgeons who had InterStim® programming training were more likely to perform their own programming [15/46 (32%) vs 6/47 (13%), p = 0.03]. Most answered all knowledge-based questions correctly (62/90, 69%); no surgeon characteristics were significantly associated with this outcome. Most surgeons cited patient comfort (71/80, 89%) and symptom relief (64/80, 80%) as important factors when reprogramming, but no prevalent themes emerged on how and why surgeons change certain programming parameters. CONCLUSIONS: Surgeons who had formal InterStim® programming training are more likely to perform programming themselves. No surgeon characteristic was associated with improved programming knowledge. We found that surgeons prioritize patient comfort and symptoms when deciding to reprogram.