search
Back to results

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

Primary Purpose

Rectum Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Early removal group
Normal removal group
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectum Cancer focused on measuring laparoscopic mesorectal excision, rectal cancer, urinary distention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Peking union medical college hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early removal group

Normal removal group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Urethrorrhagia
take a mid-stream urine sample for Clinical urine tests and RBC≥3/HP is defined as urethrorrhagia.

Full Information

First Posted
February 23, 2017
Last Updated
February 23, 2017
Sponsor
Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03065855
Brief Title
Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum
Official Title
Amonocenter, Prospective, Randomized Clinical Trial to Investigate the Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2017 (Anticipated)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectum Cancer
Keywords
laparoscopic mesorectal excision, rectal cancer, urinary distention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early removal group
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal removal group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Early removal group
Intervention Description
Participants assigned to the experimental arm will have their urethral catheters removed at 2 days after after laparoscopic anterior resection of the rectum.
Intervention Type
Procedure
Intervention Name(s)
Normal removal group
Intervention Description
Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution.
Primary Outcome Measure Information:
Title
Post-operative urinary retention requiring re-catheterisation
Description
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
Time Frame
1 day following urethral catheter removal
Secondary Outcome Measure Information:
Title
Urinary tract infection
Description
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.
Time Frame
Within 7 days of urethral catheter removal
Title
Urethrorrhagia
Description
take a mid-stream urine sample for Clinical urine tests and RBC≥3/HP is defined as urethrorrhagia.
Time Frame
Within 7 days of urethral catheter removal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
XU Lai
Email
drxulai@pumch.cn
Facility Information:
Facility Name
Peking union medical college hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Lai
Email
drxulai@pumch.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Other researchers have access to data in the form of published papers
Citations:
PubMed Identifier
34184246
Citation
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.
Results Reference
derived
PubMed Identifier
30770766
Citation
Xu 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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs