Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum
Amonocenter, Prospective, Randomized Clinical Trial to Investigate the Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum.
1 other identifier
interventional
220
1 country
1
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 However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief，but there is no clear data on the incidence of urine retention.Longer retaining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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
February 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFebruary 28, 2017
January 1, 2017
5 months
February 23, 2017
February 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Urinary tract infection
Within 7 days of urethral catheter removal
Urethrorrhagia
Within 7 days of urethral catheter removal
Study Arms (2)
Early removal group
EXPERIMENTALAll 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.
Normal removal group
ACTIVE COMPARATORAll 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.
Interventions
Participants assigned to the experimental arm will have their urethral catheters removed at 2 days after after laparoscopic anterior resection of the rectum.
Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking union medical college hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (2)
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
PMID: 34184246DERIVEDXu L, Tao ZY, Lu JY, Zhang GN, Qiu HZ, Wu B, Lin GL, Xu T, Xiao Y. A single-center, prospective, randomized clinical trial to investigate the optimal removal time of the urinary catheter after laparoscopic anterior resection of the rectum: study protocol for a randomized controlled trial. Trials. 2019 Feb 15;20(1):133. doi: 10.1186/s13063-019-3210-1.
PMID: 30770766DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2017
First Posted
February 28, 2017
Study Start
February 1, 2017
Primary Completion
July 1, 2017
Study Completion
August 1, 2017
Last Updated
February 28, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
Other researchers have access to data in the form of published papers