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

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 Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.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Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period.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

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

Conditions
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Urinary Retention

Intervention / Treatment
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* Other: Removal of urethral catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group 1<br>Early removal of urethral catheter 48 hours post-operatively. | Other: Removal of urethral catheter<br>* 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.<br>* Other names: Indwelling urethral catheter;|
| Other: Study group 2<br>Removal of urethral catheter once epidural analgesia has been withdrawn. | Other: Removal of urethral catheter<br>* 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.<br>* Other names: Indwelling urethral catheter;|

What is the study measuring?
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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 |