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

Not Applicable

• Conditions: Rectum Cancer
• Interventions: Procedure: Normal removal group; Procedure: Early removal group

• Registration Number: NCT03065855
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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 However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief，but there is no clear data on the incidence of urine retention.Longer retaining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

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 However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief.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

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Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-02
• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-02-23
• Last Update Submitted: 2017-02-23
• Study First Posted: 2017-02-28
• Last Update Posted: 2017-02-28
• Primary Completion: 2017-07
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Competent to consent to participate in trial
2. Patients with rectal cancer who underwent total or tumor-specific-mesorectal excision with colorectal or colonanal anastomosis
3. Elective surgery
4. ASA classification of 1~3
5. If male, international prostate symptom score <20.

Exclusion Criteria

1. Combined pelvic surgery(pelvic lymph node dissection, hysterectomy, salpingo-oophorectomy, posterior vaginectomy, cystectomy, ureteral double-J stenting, ureterectomy, ureteroureterostomy, prostatectomy)
2. Postoperative complications with a Dindo grade III or more
3. Known urinary disease(end-stage renal disease, benign prostatic hyperplasia, neurogenic bladder, malignancy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal removal group	Normal removal group	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.
Early removal group	Early removal group	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.

Primary Outcome Measures

Name	Time	Method
Post-operative urinary retention requiring re-catheterisation	1 day 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 1 day of removal of urethral catheter in the post-operative period

Secondary Outcome Measures

Name	Time	Method
Urinary tract infection	Within 7 days of urethral catheter removal	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.
Urethrorrhagia	Within 7 days of urethral catheter removal	take a mid-stream urine sample for Clinical urine tests and RBC≥3/HP is defined as urethrorrhagia.

Trial Locations

Locations (1)

Peking union medical college hospital; 🇨🇳 Beijing, Beijing, China