Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum

Study Overview
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Brief Summary
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Traditionally these catheters are retained for 7 days, because a higher incidence of urinary retention is related to early removal of the urinary catheter. However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief，but there is no clear data on the incidence of urine retention.Longer retaining time of urethral catheter would induce the urinary tract infection while early removal of urethral catheter is considered to develop acute retention of urine due to lack of sensation when the bladder is full. Taking the comfort and mobility for faster rehabilitation of patients into account, the investigators aim at obtain the optimal removal time of urinary catheter after after laparoscopic anterior resection of the rectum

Detailed Description
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For a better view to avoid accidental trauma and monitoring kidney function during surgery and in the post-surgery period, patients undergoing abdominal operations will usually have a urinary catheter placed in the bladder before the surgery. Traditionally these catheters are retained for 7 days, because a higher incidence of urinary retention is related to early removal of the urinary catheter. However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief. Longer retaining time of urethral catheter would induce the urinary tract infection while early removal of urethral catheter is considered to develop acute retention of urine due to lack of sensation when the bladder is full. Taking the comfort and mobility for faster rehabilitation of patients into account, the investigators aim at obtain the optimal removal time of urinary catheter after after laparoscopic anterior resection of the rectum .

Official Title
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Amonocenter, Prospective, Randomized Clinical Trial to Investigate the Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum.

Conditions
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Rectum Cancer

Intervention / Treatment
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* Procedure: Early removal group
* Procedure: Normal removal group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Competent to consent to participate in trial Patients with rectal cancer who underwent total or tumor-specific-mesorectal excision with colorectal or colonanal anastomosis Elective surgery ASA classification of 1 3 If male, international prostate symptom score <20. Exclusion Criteria: Combined pelvic surgery(pelvic lymph node dissection, hysterectomy, salpingo-oophorectomy, posterior vaginectomy, cystectomy, ureteral double-J stenting, ureterectomy, ureteroureterostomy, prostatectomy) Postoperative complications with a Dindo grade III or more Known urinary disease(end-stage renal disease, benign prostatic hyperplasia, neurogenic bladder, malignancy)

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early removal group<br>All participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior. 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 2 days following surgery. | Procedure: Early removal group<br>* Participants assigned to the experimental arm will have their urethral catheters removed at 2 days after after laparoscopic anterior resection of the rectum.<br>|
| Active Comparator: Normal removal group<br>All participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution. | Procedure: Normal removal group<br>* Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution.<br>|

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 1 day of removal of urethral catheter in the post-operative period | 1 day following urethral catheter removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary tract infection | Before catheter removal, take a mid-stream urine sample for microscopy and culture. Leucocyte in urine ≥5/HP for man and ≥10/HP for woman is defined as bacteruria with urinary irritation or not.A pure culture of a single organism of >100,000 colony forming units will be considered a positive culture. | Within 7 days of urethral catheter removal | 
| Urethrorrhagia | take a mid-stream urine sample for Clinical urine tests and RBC≥3/HP is defined as urethrorrhagia. | Within 7 days of urethral catheter removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic mesorectal excision, rectal cancer, urinary distention