Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery
Completed · Not applicable
Conditions studied: Urinary Retention
In brief
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).
Key facts
- Study ID
- NCT01923129
- Run by
- Cedars-Sinai Medical Center
- People needed
- 142
- Starts
- 2012-11-30
- Expected to finish
- 2017-11-22
- Last updated by the study team
- 2019-02-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
- Males or females, >18 years of age inclusive at the time of study screening;
- American Society of Anesthesiologists (ASA) Class I-III;
- Infraperitoneal colorectal surgery (open and/or laparoscopic);
- Elective Surgery
You may not qualify if…
- Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
- Children <18;
- No perioperative antibiotics;
- Past or current urinary tract malignancy;
- Urinary catheter inserted before surgery;
- Chronic kidney insufficiency with Creatinine> 2
- Diagnosis of benign prostatic hyperplasia
- Chronic urinary infections
- Neurogenic bladder
- History of enterovesical fistula
- Pregnancy
- Prior surgery of the lower urinary tract
- Epidural
- Perioperative ureteral stents
- After randomization:
- Catheter pulled out inadvertently;
- Postoperative complications requiring prolonged monitoring of urine output
- Postoperative complications requiring early reoperation
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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