The consequences of fear

Our modern world is a risky place and evokes many well-founded fears. But these fears themselves create a new risk for our health and well-being that needs to be addresse

Laparoscopic radical prostatectomy: omitting a pelvic drain

PURPOSE: Our goal was to assess outcomes of a selective drain placement strategy during laparoscopic radical prostatectomy (LRP) with a running urethrovesical anastomosis (RUVA) using cystographic imaging in all patients. Materials and Methods: A retrospective chart review was performed for all patients undergoing LRP between January 2003 and December 2004. The anastomosis was performed using a modified van Velthoven technique. A drain was placed at the discretion of the senior surgeon when a urinary leak was demonstrated with bladder irrigation, clinical suspicion for a urinary leak was high, or a complex bladder neck reconstruction was performed. Routine postoperative cystograms were obtained. RESULTS: 208 patients underwent LRP with a RUVA. Data including cystogram was available for 206 patients. The overall rate of cystographic urine leak was 5.8%. A drain was placed in 51 patients. Of these, 8 (15.6%) had a postoperative leak on cystogram. Of the 157 undrained patients, urine leak was radiographically visible in 4 (2.5%). The higher leak rate in the drained vs. undrained cohort was statistically significant (p = 0.002). Twenty-four patients underwent pelvic lymph node dissection (8 drained, 16 undrained). Three undrained patients developed lymphoceles, which presented clinically on average 3 weeks postoperatively. There were no urinomas or hematomas in either group. CONCLUSIONS: Routine placement of a pelvic drain after LRP with a RUVA is not necessary, unless the anastomotic integrity is suboptimal intraoperatively. Experienced clinical judgment is essential and accurate in identifying patients at risk for postoperative leakage. When suspicion is low, omitting a drain does not increase morbidity

Peritoneal flap for lymphocele prophylaxis following robotic-assisted laparoscopic radical prostatectomy with pelvic lymph node dissection: study protocol and trial update for the randomized controlled PELYCAN study

Background!#!Data from interventional studies suggest that a peritoneal flap after pelvic lymph node dissection (LND) during laparoscopic, robotic-assisted radical prostatectomy (RARP) may reduce the rate of symptomatic lymphoceles in transperitoneal approach. However, most of these studies are not conducted in a randomized controlled fashion, thus limiting their scientific value. A recent prospective, randomized, controlled trial (RCT) did not show superiority of a peritoneal flap while further trials are lacking. Therefore, the aim of the presented RCT will be to show that creating a peritoneal flap decreases the rate of symptomatic lymphoceles compared to the current standard procedure without creation of a flap.!##!Methods/design!#!PELYCAN is a parallel-group, patient- and assessor-blinded, phase III, adaptive randomized controlled superiority trial. Men with histologically confirmed prostate cancer who undergo transperitoneal RARP with pelvic LND will be randomly assigned in a 1:1 ratio to two groups-either with creating a peritoneal flap (PELYCAN) or without creating a peritoneal flap (control). Sample size calculation yielded a sample size of 300 with a planned interim analysis after 120 patients, which will be performed by an independent statistician. This provides a possibility for early stopping or sample size recalculation. Patients will be stratified for contributing factors for the development of postoperative lymphoceles. The primary outcome measure will be the rate of symptomatic lymphoceles in both groups within 6 months postoperatively. Patients and assessors will be blinded for the intervention until the end of the follow-up period of 6 months. The surgeon will be informed about the randomization result after performance of vesicourethral anastomosis. Secondary outcome measures include asymptomatic lymphoceles at the time of discharge and within 6 months of follow-up, postoperative complications, mortality, re-admission rate, and quality of life assessed by the EORTC QLQ-C30 questionnaire.!##!Discussion!#!The PELYCAN study is designed to assess whether the application of a peritoneal flap during RARP reduces the rate of symptomatic lymphoceles, as compared with the standard operation technique. In case of superiority of the intervention, this peritoneal flap may be suggested as a new standard of care.!##!Trial registration!#!German Clinical Trials Register DRKS00016794 . Registered on 14 May 2019