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A Randomized Control Trial Of Anti-Inflammatory Regional Hypothermia On Urinary Continence During Robot-Assisted Radical Prostatectomy.

ABSTRACT: The present study seeks to present a single-blind, randomized control trial of a hypothermic anti-inflammatory device, the endorectal cooling balloon (ECB), to assess whether regional hypothermia could improve 90-day and time to pad-free continence following robot-assisted radical prostatectomy (RARP). Five high-volume surgeons at three institutions had patients randomized (1:1) to regional hypothermia with ECB versus control. Patients were blinded to device use, as it was inserted and removed intraoperatively. Knowledge of device use was restricted to the operating room personnel only; recovery room and ward nursing staff were not informed of device use and instructed to indicate such if a patient inquired. An independent and blinded data acquisition contractor assessed outcomes via components of the EPIC and IPSS. The primary outcome was categorical pad-free continence at 90-days and the secondary outcome was a Kaplan-Meier time-to pad-free continence at 90?days. 100 hypothermia and 99 control patients were included. The primary outcome of 90-day pad-free continence was 50.0% (27.8-70.0%) in the hypothermia group versus 59.2% (33.3-78.6%) in the control (p?=?0.194). The secondary outcome of Kaplan Meier analysis for time to 90-day continence was not statistically significant. At one year, there were also no statistically significant differences in continence recovery. Post-hoc analysis revealed a trend towards improvement in continence in one of three sites. Overall, the trial demonstrated no benefit to regional hypothermia either in our primary or secondary outcomes. It is suggested that surgical technique and prevention of surgical trauma may be more advantageous to improving continence recovery.

SUBMITTER: Huynh LM

PROVIDER: S-EPMC6218497 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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A Randomized Control Trial Of Anti-Inflammatory Regional Hypothermia On Urinary Continence During Robot-Assisted Radical Prostatectomy.

Huynh Linda M LM Skarecky Douglas D Porter James J Wagner Christian C Witt Jorn J Wilson Timothy T Lau Clayton C Ahlering Thomas E TE

Scientific reports 20181105 1

The present study seeks to present a single-blind, randomized control trial of a hypothermic anti-inflammatory device, the endorectal cooling balloon (ECB), to assess whether regional hypothermia could improve 90-day and time to pad-free continence following robot-assisted radical prostatectomy (RARP). Five high-volume surgeons at three institutions had patients randomized (1:1) to regional hypothermia with ECB versus control. Patients were blinded to device use, as it was inserted and removed i ...[more]

PMID: 30397236

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Project description:Preservation of continence and sexual function continues to be a formidable quality-of-life issue regarding outcomes after radical prostatectomy. There is little argument that physical preservation of the nerves and sphincters is a critical component to achieving success in these domains. Previously demonstrated factors such as advancing age, deteriorating physical health status, and subnormal baseline potency negatively impact outcomes. Our hypothesis, however, has been that inflammatory response to surgery has a large impact on surgical outcomes of prostatectomy. Trauma-induced inflammation could account for variation in recovery despite nearly identical surgery on many patients, especially in high-volume surgeons. In other words, we suggest and maintain that younger and healthier patients tolerate and/or recover better from the trauma/inflammation of surgery. Those who do not recover as well may have altered inflammatory response to injury. A common response to decrease inflammation in response to physical injury would be as simple as to cool the injury with ice. Previous neurologic studies have suggested that using ice during surgical intervention can reduce the inflammatory damage. Therefore, we applied this concept that preemptive hypothermia could reduce inflammation to the robot-assisted prostatectomy procedure to potentially lead to improved continence and potency outcomes. In 2009, we introduced the concept of regional hypothermia via an endorectal cooling balloon during robot-assisted radical prostatectomy (RARP). We have published our single institution data demonstrating a significant reduction of overall incontinence. Defining continence as zero-pads, our overall 1-year incontinence has been reduced by 70% (from 13% to 4%). Severe incontinence, defined as two or more pads, was likewise reduced by 70% (from 2.9% to 0.9%). Regional hypothermia used during the time of surgery represents a novel strategy for minimizing inflammation and subsequent muscle and nerve damage in RARP.

Project description:BackgroundWe recently reported the importance of deep learning (DL) of pelvic magnetic resonance imaging in predicting the degree of urinary incontinence (UI) following robot-assisted radical prostatectomy (RARP). However, our results were limited because the prediction accuracy was approximately 70%.AimTo develop a more precise prediction model that can inform patients about UI recovery post-RARP surgery using a DL model based on intraoperative video images.Methods and resultsThe study cohort comprised of 101 patients with localized prostate cancer undergoing RARP. Three snapshots from intraoperative video recordings showing the pelvic cavity (prior to bladder neck incision, immediately following prostate removal, and after vesicourethral anastomosis) were evaluated, including pre- and intraoperative parameters. We evaluated the DL model plus simple or ensemble machine learning (ML), and the area under the receiver operating characteristic curve (AUC) was analyzed through sensitivity and specificity. Of 101, 64 and 37 patients demonstrated "early continence (using 0 or 1 safety pad at 3 months post-RARP)" and "late continence (others)," respectively, at 3 months postoperatively. The combination of DL and simple ML using intraoperative video snapshots with clinicopathological parameters had a notably high performance (AUC, 0.683-0.749) to predict early recovery from UI after surgery. Furthermore, combining DL with ensemble artificial neural network using intraoperative video snapshots had the highest performance (AUC, 0.882; sensitivity, 92.2%; specificity, 78.4%; overall accuracy, 85.3%) to predict early recovery from post-RARP incontinence, with similar results by internal validation. The addition of clinicopathological parameters showed no additive effects for each analysis using DL, EL and simple ML.ConclusionOur findings suggest that the DL algorithm with intraoperative video imaging is a reliable method for informing patients about the severity of their recovery from UI after RARP, although it is not clear if our methods are reproducible for predicting long-term UI and pad-free continence.

Project description:ObjectiveTo describe a novel RoboSling technique performed at the time of robot-assisted radical prostatectomy (RARP) and its utility for enhancing urinary function recovery postoperatively.Materials and methodsThe surgical technique involves harvesting a vascularised, fascial flap from the peritoneum on the posterior aspect of the bladder. Following completion of prostatectomy, the autologous flap is tunnelled underneath the bladder and incorporated into the rectourethralis and vertical longitudinal detrusor fibres at the posterior bladder neck with a modified Rocco suture. After urethra-vesical anastomosis is completed, the corners of the flap are hitched up to Cooper's ligament bilaterally with V-Loc sutures, tensioned and secured creating a bladder neck sling. A prospective, longitudinal cohort study was performed of 193 consecutive patients undergoing RARP between December 2016 and September 2019. The first 163 patients underwent standard RARP, and the last 30 patients had the RoboSling technique performed concurrently. Continence outcomes were the primary outcomes assessed using pad number and Expanded Prostate Cancer Composite (EPIC)-urinary domain questionnaire. Operative time (OT), estimated blood loss (EBL), complications and oncological outcomes were secondary outcomes.ResultsThe two groups were comparable for demographics and clinicopathological variables. At 3 months, zero pad usage (p = 0.005) and continence rates, defined as EPIC score ≥ 85 (p = 0.007), were both higher in the RoboSling group. EBL, complication rate and positive surgical margin rate did not differ between the two groups. Superior zero pad usage was observed at 1 year in the RoboSling group (p = 0.029). The RoboSling technique added on average 16 min to OT.ConclusionsThe RoboSling procedure at the time of RARP was associated with earlier return to continence without negatively impacting other postoperative outcomes. This improvement in continence outcomes was maintained long term.

Dataset Information

A Randomized Control Trial Of Anti-Inflammatory Regional Hypothermia On Urinary Continence During Robot-Assisted Radical Prostatectomy.

Publications

A Randomized Control Trial Of Anti-Inflammatory Regional Hypothermia On Urinary Continence During Robot-Assisted Radical Prostatectomy.

Similar Datasets

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