Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia

Prospective Randomized Controlled Trial of Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia

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Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.

Study Overview

• Status: Completed
• Conditions: Urinary Retention
• Intervention / Treatment: Other: Removal of urethral catheter

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Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period.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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Co. Galway
    • Galway, Co. Galway, Ireland
      • University College Hospital Galway

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study group 1; Early removal of urethral catheter 48 hours post-operatively.	Other: Removal of urethral catheter; 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.; Other Names: Urethral catheter; Indwelling Urinary catheter; Indwelling urethral catheter
OTHER: Study group 2; Removal of urethral catheter once epidural analgesia has been withdrawn.	Other: Removal of urethral catheter; 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.; Other Names: Urethral catheter; Indwelling Urinary catheter; Indwelling urethral catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 days following urethral catheter removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 14 days of urethral catheter removal
Pulmonary complications	The development of post-operative pulmonary complications such as atelectasis, pneumonia occurring within 14 days of surgery will be considered.	For the first 14 days post-operatively
Surgical site infection	The development of wound and other surgical site infections within 7 days of undergoing colorectal surgery will be considered.	Within 7 days post-operatively

Collaborators and Investigators

• Sponsor: University College Hospital Galway
• Investigators: Principal Investigator: Myles R. Joyce, MB, BCh, BAO, University College Hospital Galway

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: January 4, 2012
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (ESTIMATE): January 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 19, 2013
• Last Update Submitted That Met QC Criteria: August 16, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: Joyce-2011