Early Removal of Urinary Catheters in Patients After Rectal Surgery: a Prospective Study
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early urinary catheter removal
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring Colon/Rectal Cancer Rectal Cancer, Quality of Life
Eligibility Criteria
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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Early urinary catheter removal
Arm Description
Outcomes
Primary Outcome Measures
urinary retention
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01186237
Brief Title
Early Removal of Urinary Catheters in Patients After Rectal Surgery: a Prospective Study
Official Title
Early Removal of Urinary Catheters in Patients After Rectal Surgery: a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 2010 (Actual)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
All patients will have foley catheters removed between 0600 and midnight of post-operative day 3 (Day 0 being the day of operation).
All patients will undergo bladder ultrasound prior to catheter removal.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colon/Rectal Cancer Rectal Cancer, Quality of Life
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early urinary catheter removal
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Early urinary catheter removal
Intervention Description
All patients will have foley catheters removed between 0600 and midnight of post-operative day 3 (Day 0 being the day of operation).
Primary Outcome Measure Information:
Title
urinary retention
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Lane Welton
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Removal of Urinary Catheters in Patients After Rectal Surgery: a Prospective Study
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