Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery



Status:Completed
Conditions:Overactive Bladder, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:November 30, 2012
End Date:November 22, 2017

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

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).

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. In the era of multimodal recovery
algorithms emphasizing early diet advancement, ambulation, and shorter hospital length of
stay, unnecessarily prolonging catheterization may interfere with many of these objectives.
An indwelling urinary catheter interferes with early patient mobilization potentially
lengthening hospitalization and subjects patients to an increased risk of urinary tract
infection. A study of 2,355 consecutive patients undergoing primary colorectal cancer
resection via laparotomy found an overall prevalence of postoperative urinary retention of
5.5%, however, those patients undergoing low pelvic surgery experience an almost 16%
incidence in urinary retention.

Postoperative urinary catheter drainage after infraperitoneal colorectal surgery is commonly
practiced, assuming some degree of nerve damage to the superior hypogastric plexus at the
sacral promontory or of the nervi erigentes at the pelvic side wall resulting from pelvic
dissection, causing transient or permanent dysfunction of the lower urinary tract. It has
been believed that this intraoperative damage to the pelvic autonomic nerves may be
associated with early postoperative acute urinary retention, and justifies an indwelling
urinary catheter for several days following infraperitoneal pelvic surgery. However, there is
no general agreement about the optimal duration of postoperative urinary drainage, with
relevant literature reporting durations ranging from 1 to 10 days.

Prolonged indwelling urinary catheter has been associated with increased risk of urinary
tract infections, with the risk of bacteriuria between 3 and 10% per day when catheterized,
with the risk of urinary tract infection increasing by 5% to 10% per catheter day after the
second day of catheterization. The incidence of urinary tract infections after anorectal
surgery and 5 days of catheterization has been shown to range between 42% and 60%. Higher
mortality rates have been reported in hospitalized patients who developed urinary tract
infection after indwelling catheterization with the incidence of bacteremia after single
catheterization reported to be as high as 8%.

The optimal duration of urinary drainage after infraperitoneal colorectal surgery is unknown.
Based on the autonomic mechanisms of micturition in relation to the striated muscle fibers of
the external urethral sphincter, alpha blockade has been studied as a potential intervention
to reduce the incidence of re-catheterization. A large Cochrane Database reviewed their role
in five randomized trials, with four trials favoring alpha blockade over placebo.
Furthermore, the side-effect profile of alpha-blockade was low and compared favorably to
placebo.

Prior studies have suggested urinary bladder catheter drainage removed on postoperative day
one following pelvic surgery may be safe and decrease the incidence of urinary tract
infection. However, the study was underpowered to detect meaningful conclusions. A larger
study investigating the optimal duration of urinary drainage concluded that removing the
catheter one day postoperatively in patients undergoing infraperitoneal colorectal surgery is
appropriate, unless a low rectal carcinoma is present or lymph node metastatic disease is
present. The investigators wish to further substantiate this evidence and introduce the
positive findings associated with alpha-blockade in minimizing the need for
re-catheterization.

The investigators therefore propose a prospective, controlled randomized trial to compare the
effects of 1 day's transurethral catheterization after infraperitoneal surgery with an alpha
blockade medication compared to those of 3 days of catheterization, with acute urinary
retention as a primary endpoint.

Inclusion Criteria:

1. Able to freely give written informed consent to participate in the study and have
signed the Informed Consent Form;

2. Males or females, >18 years of age inclusive at the time of study screening;

3. American Society of Anesthesiologists (ASA) Class I-III;

4. Infraperitoneal colorectal surgery (open and/or laparoscopic);

5. Elective Surgery

Exclusion Criteria:

1. Mentally incompetent or unable or unwilling to provide informed consent or comply with
study procedures;

2. Children <18;

3. No perioperative antibiotics;

4. Past or current urinary tract malignancy;

5. Urinary catheter inserted before surgery;

6. Chronic kidney insufficiency with Creatinine> 2

7. Diagnosis of benign prostatic hyperplasia

8. Chronic urinary infections

9. Neurogenic bladder

10. History of enterovesical fistula

11. Pregnancy

12. Prior surgery of the lower urinary tract

13. Epidural

14. Perioperative ureteral stents

After randomization:

1. Catheter pulled out inadvertently;

2. Postoperative complications requiring prolonged monitoring of urine output

3. Postoperative complications requiring early reoperation
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-289-8690
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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