CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 142 enrolled
Drug / intervention
Prazosin given 6 hours prior to catheter removal in the 24 hour groupdrug
Likely dose
Prazosin given 6 hours prior to catheter removal in the 24 hour group 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01923129
NCT01923129N/ACompleted

Prospective Study Investigating Optimal Duration of Indwelling Urinary Catheter Following Infraperitoneal Colorectal Surgery and Role of Postoperative Alpha Blockade

Cedars-Sinai Medical Center·interventional·Posted Aug 15, 2013·Updated Feb 20, 2019

In Brief

A clinical study evaluating Prazosin given 6 hours prior to catheter removal in the 24 hour group for Urinary Retention. Completed, enrolled 142 participants across 1 site.

Detailed Summary

There is no general agreement about the optimal duration of postoperative urinary drainage, with relevant literature reporting durations ranging from 1 to 10 days. The available research supporting the routine use of prolonged catheterization is limited and studies investigating early removal following infraperitoneal colorectal surgery have largely been underpowered to form valid practice conclusions. The aim of the investigators study is to determine whether a postoperative colorectal patient can safely have an indwelling catheter removed on postoperative day one (24 hours following surgery) with the addition of a study medication (prazosin), without a statistically significant difference in the incidence of urinary retention compared to the standard, accepted approach of delayed removal (72 hours postoperatively). Patients undergoing laparoscopic and open pelvic colorectal surgery below the peritoneal reflection for both benign and malignant conditions will be randomized into two groups: group one will have the catheter removed on postoperative day 3 (72 hours postoperatively) Group 2 will have a dose of the alpha-blocker prazosin given 6 hours prior to catheter removal and will have the urinary catheter removed on postoperative day 1 (24 hours postoperatively).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 15, 2013
Enrollment StartNov 30, 2012
Primary CompletionNov 22, 2017
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 12.9 years ago

Interventions

Prazosin given 6 hours prior to catheter removal in the 24 hour groupdrug

Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)