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

Not Applicable

Completed

• Conditions: Urinary Retention
• Interventions: Other: Removal of urethral catheter

• Registration Number: NCT01508767
• Lead Sponsor: University College Hospital Galway

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Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.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Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period.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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-16
• Last Update Posted: 2013-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group 1	Removal of urethral catheter	Early removal of urethral catheter 48 hours post-operatively.
Study group 2	Removal of urethral catheter	Removal of urethral catheter once epidural analgesia has been withdrawn.

Primary Outcome Measures

Name	Time	Method
Post-operative urinary retention requiring re-catheterisation	14 days following urethral catheter removal	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

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

Trial Locations

Locations (1)

University College Hospital Galway; 🇮🇪 Galway, Co. Galway, Ireland