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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03065855
Collaborator
(none)
220
1
2
5.9
37

Study Details

Study Description

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 However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief,but there is no clear data on the incidence of urine retention.Longer retaining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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Early removal group
  • Procedure: Normal removal group
N/A

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 However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief.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

.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Amonocenter, Prospective, Randomized Clinical Trial to Investigate the Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum.
Anticipated Study Start Date :
Feb 1, 2017
Anticipated Primary Completion Date :
Jul 1, 2017
Anticipated Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: Early removal group
Participants assigned to the experimental arm will have their urethral catheters removed at 2 days after after laparoscopic anterior resection of the rectum.

Active Comparator: 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.

Procedure: Normal removal group
Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking union medical college hospital Beijing Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT03065855
Other Study ID Numbers:
  • ARCTIC
First Posted:
Feb 28, 2017
Last Update Posted:
Feb 28, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking Union Medical College Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 28, 2017