Early Removal of Urinary Catheters in Patients After Rectal Surgery: a Prospective Study

March 17, 2021 updated by: Stanford University
Recent national surgical quality guidelines (Surgical Care Improvement Project, National Hospital Inpatient Quality Measures)state that removal of urinary catheters should occur by post-operative day two for all surgical patients. These guidelines exclude neither patients who have undergone rectal surgery nor those with epidural analgesic catheters. The common practice among most colorectal surgeons is to leave urinary catheters in for three to five days for patients who have undergone rectal operations, due to concern for urinary retention. This study aims to explore the outcomes of following the national surgical guidelines for early urinary catheter removal, especially with regards to urinary retention and urinary tract infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients undergoing anterior resection (rectosigmoid), low anterior resection, abdomino-perineal resection, total proctocolectomy with ileal pouch-anal anastomosis, sigmoid colectomy, and coloanal anastomosis will be included in the study. All patients will undergo standard pre-operative work-up prior to the operation. As part of the operative note, the level of the anastomosis must be documented.

  1. All patients will have foley catheters removed between 0600 and midnight of post-operative day 3 (Day 0 being the day of operation).
  2. All patients will undergo bladder ultrasound prior to catheter removal.
  3. All patients will undergo bladder ultrasound by nursing staff six hours after catheter removal, and after voiding the first time after catheter removal, or if the patient experiences symptoms of urinary retention.

6. Patients who meet definition of urinary retention (>100cc post-void residual) will undergo intermittent straight catheterization every six hours or with symptoms. For those who refuse intermittent straight catheterization, a indwelling urinary catheter will be inserted and left in for 24 hours before removal.

7. For patients who have low urine output indicating under-resuscitation, indwelling catheters will be re-inserted and removed when ongoing resuscitation measures are completed.

8. For patients who are actively undergoing fluid resuscitation on post-operative day 3 will not have their urinary catheters removed until resuscitation and monitoring is complete.

9. Patients who report symptoms of benign prostatic hypertrophy (BPH) and/or are already on medications for BPH will be continued on those medications starting on post-operative day 1.

10. Patients who have persistent urinary retention when they are otherwise ready to be discharged home will be sent home with a leg bag and follow up in urology clinic for voiding trial in 1-2 weeks.

11. Urinalysis/urine culture will be performed for symptomatic patients.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

All patients at Stanford Hospital undergoing:

  • anterior resection
  • sigmoid colectomy
  • low anterior resection
  • abdomino-perineal resection
  • total proctocolectomy with ileal pouch-analanastomosis
  • coloanalanastomosis.

Exclusion criteria Patients with history of neurogenic bladder who had indwelling catheters or required intermittent straight catheterization prior to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early urinary catheter removal
Procedure: Early urinary catheter removal
All patients will have foley catheters removed between 0600 and midnight of post-operative day 3 (Day 0 being the day of operation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
urinary retention
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Mark Lane Welton, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (Estimate)

August 23, 2010

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC0004
  • 17865 (Other Identifier: Stanford University)
  • SU-05272010-6187 (Other Identifier: Stanford University)
  • NCI-2010-02350

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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