Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
Primary Purpose
Urinary Retention
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Removal of urethral catheter
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Retention
Eligibility Criteria
Inclusion Criteria:
- Age > 18
- Competent to consent to participate in trial
- Undergoing colorectal surgery (any resection of large bowel, formation of colostomy, anterior resection, low anterior resection, panproctocolectomy, abdominoperineal resection).
- Receiving epidural analgesia post-operatively
- If male, international prostate symptom score <20.
Exclusion Criteria:
- Previous lower urinary tract surgery
- Chronic lower urinary tract disease
- Intermittent self-catheterisation
- Neurogenic bladder
- Urethral catheter inserted >24 hours pre-operatively
- Presence of pelvic sepsis/abscess at surgery
- Previous trans-abdominal pelvic surgery
- Urethral catheter required for urine output monitoring beyond 24 hours post-operatively
- Presence of enterovesical fistula
- Pre-operative use of medications which alter detrusor function
- Pregnancy
Sites / Locations
- University College Hospital Galway
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Study group 1
Study group 2
Arm Description
Early removal of urethral catheter 48 hours post-operatively.
Removal of urethral catheter once epidural analgesia has been withdrawn.
Outcomes
Primary Outcome Measures
Post-operative urinary retention requiring re-catheterisation
Development of acute post-operative urinary retention demonstrated by a post-void residual >100mls on bladder ultrasound requiring re-catheterisation within 2 weeks of removal of urethral catheter in the post-operative period.
Secondary Outcome Measures
Symptomatic bacteruria
Should a patient experience lower urinary tract symptoms following catheter removal a mid-stream urine sample will be taken for microscopy and culture. A pure culture of a single organism of >100,000 colony forming units will be considered a positive culture.
Pulmonary complications
The development of post-operative pulmonary complications such as atelectasis, pneumonia occurring within 14 days of surgery will be considered.
Surgical site infection
The development of wound and other surgical site infections within 7 days of undergoing colorectal surgery will be considered.
Full Information
NCT ID
NCT01508767
First Posted
January 4, 2012
Last Updated
August 16, 2013
Sponsor
University College Hospital Galway
1. Study Identification
Unique Protocol Identification Number
NCT01508767
Brief Title
Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
Official Title
Prospective Randomized Controlled Trial of Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Hospital Galway
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients undergoing colon or rectal surgery will usually have a urinary catheter (silicone tube) placed in the bladder at the time of operating to monitor kidney function during surgery and in the post-surgery period. Such patients will also have an infusion into the spine, known as an epidural, after surgery to provide them with continuous pain relief. Urinary catheters should be removed as early as possible once they are no longer required to facilitate patients becoming mobile after surgery and to reduce the risk of patients developing a urinary tract infection.
Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.
Detailed Description
Patients undergoing colon or rectal surgery will be randomly assigned to one of two groups: Patients in study group 1 (SG1) will have their urinary catheters removed at 48 hours post-operatively; Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period. We will be primarily examining rates of urinary retention in both groups. We will also be examining rates of urinary tract infection, chest infection (frequently a result of poor mobility after surgery), and wound infection and other complications after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group 1
Arm Type
Experimental
Arm Description
Early removal of urethral catheter 48 hours post-operatively.
Arm Title
Study group 2
Arm Type
Other
Arm Description
Removal of urethral catheter once epidural analgesia has been withdrawn.
Intervention Type
Other
Intervention Name(s)
Removal of urethral catheter
Other Intervention Name(s)
Urethral catheter, Indwelling Urinary catheter, Indwelling urethral catheter
Intervention Description
All participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior to undergoing colorectal resection. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the experimental arm will have their urethral catheters removed at 48 hours following surgery. Participants assigned to the control group will have their urethral catheters removed within 12 hours of withdrawal of the epidural infusion, as is standard practice in our institution.
Primary Outcome Measure Information:
Title
Post-operative urinary retention requiring re-catheterisation
Description
Development of acute post-operative urinary retention demonstrated by a post-void residual >100mls on bladder ultrasound requiring re-catheterisation within 2 weeks of removal of urethral catheter in the post-operative period.
Time Frame
14 days following urethral catheter removal
Secondary Outcome Measure Information:
Title
Symptomatic bacteruria
Description
Should a patient experience lower urinary tract symptoms following catheter removal a mid-stream urine sample will be taken for microscopy and culture. A pure culture of a single organism of >100,000 colony forming units will be considered a positive culture.
Time Frame
Within 14 days of urethral catheter removal
Title
Pulmonary complications
Description
The development of post-operative pulmonary complications such as atelectasis, pneumonia occurring within 14 days of surgery will be considered.
Time Frame
For the first 14 days post-operatively
Title
Surgical site infection
Description
The development of wound and other surgical site infections within 7 days of undergoing colorectal surgery will be considered.
Time Frame
Within 7 days post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18
Competent to consent to participate in trial
Undergoing colorectal surgery (any resection of large bowel, formation of colostomy, anterior resection, low anterior resection, panproctocolectomy, abdominoperineal resection).
Receiving epidural analgesia post-operatively
If male, international prostate symptom score <20.
Exclusion Criteria:
Previous lower urinary tract surgery
Chronic lower urinary tract disease
Intermittent self-catheterisation
Neurogenic bladder
Urethral catheter inserted >24 hours pre-operatively
Presence of pelvic sepsis/abscess at surgery
Previous trans-abdominal pelvic surgery
Urethral catheter required for urine output monitoring beyond 24 hours post-operatively
Presence of enterovesical fistula
Pre-operative use of medications which alter detrusor function
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myles R. Joyce, MB, BCh, BAO
Organizational Affiliation
University College Hospital Galway
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Hospital Galway
City
Galway
State/Province
Co. Galway
Country
Ireland
12. IPD Sharing Statement
Citations:
PubMed Identifier
34184246
Citation
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
Results Reference
derived
PubMed Identifier
25769395
Citation
Coyle D, Joyce KM, Garvin JT, Regan M, McAnena OJ, Neary PM, Joyce MR. Early post-operative removal of urethral catheter in patients undergoing colorectal surgery with epidural analgesia - a prospective pilot clinical study. Int J Surg. 2015 Apr;16(Pt A):94-98. doi: 10.1016/j.ijsu.2015.03.003. Epub 2015 Mar 10.
Results Reference
derived
Learn more about this trial
Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
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