Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males (GRECCAR10)

July 18, 2022 updated by: University Hospital, Grenoble
The purpose of this study is to compare the urinary tract infection rate on the four postoperative day between the 2 groups of patients who have undergone total mesorectal excision for cancer and low anastomosis, with either suprapubic or transurethral catheterization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhone Alpes
      • Grenoble,, Rhone Alpes, France, 38000
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male patients of at least 18 years of age
  • Histologically proven rectal adenocarcinoma
  • Stage T1-4 Nx Mx
  • With or without neoadjuvant treatment
  • TME and low anastomosis (colorectal or coloanal, stapled or handsewn)
  • With or without loop ileostomy
  • Open or laparoscopic approach
  • Patient and doctor have signed a study specific informed consent form

Exclusion Criteria:

  • Colonic and upper third rectal cancer (No or Partial Mesorectal Excision)
  • Abdominoperineal resection
  • Associated prostate, and/or seminal glands and/or bladder resection
  • Infected tumour, Emergency surgery
  • Epidural analgesia
  • Patient with antibiotic therapy (other than prophylaxis)
  • Previous treated/untreated known prostate or bladder carcinoma
  • Patient with symptomatic preoperative voiding dysfunction (IPSS score >19)
  • Medical history of bladder catheterization for obstruction, or urethral surgery
  • Patient necessitating urinary output monitoring (impaired renal function etc)
  • Patient deprived of liberty or under guardianship or incapable of giving consent
  • Against the usual indications of suprapubic drainage and / or urethral sounding any known allergies to medical device materials. (p. ex. latex) and in general the known allergies to sterilizing agents (particularly oxide ethylene and its derivatives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: suprapubic catheterization
Intervention:suprapubic catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative.
Device: suprapubic catheterization
Experimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males
Active Comparator: transurethral catheterization
Intervention:transurethral catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative.
Device: transurethral catheterization
Active comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with urinary tract infection when using suprapubic versus transurethral catheterization as assessed by significant bacteriuria and pyuria
Time Frame: four days postoperative
The urinary tract infection, defined as significant bacteriuria ( > 104 CFU / mL) and pyuria (> 6 white blood cells per high power field) in urine samples obtained immediately after removal of the urethral catheter or clamping suprapubic catheter and removing the fourth postoperative day.
four days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of catherism as assessed by the number of days for participants with the catheter and number of participants leaving the hospital with the catheter
Time Frame: 1 month
1 month
Pain as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra
Time Frame: at 1, 2, 3 and 4 days
visual analogue scale (0-10) for both the abdomen and the urethra (a measure daily until hospital discharge )
at 1, 2, 3 and 4 days
Participants morbidity and mortality as assessed by Dindo and Clavien classification
Time Frame: at 1 month and 6 months
at 1 month and 6 months
Rate of satisfaction for participants as assessed by questionnaries (Fact-C and EQ-5D-3L
Time Frame: at 30 days and 6 months
Patient satisfaction : very, or moderately dissatisfied , unchanged , slightly , moderately , or very disappointed at the exit of the Fact- C hospital and EQ-5D - 3L at 30 days and 6 months.
at 30 days and 6 months
Cost as assessed by the addition of the costs of the full process depending on the catheterism duration and additional consultations and readmissions for complications
Time Frame: at 6 months
Estimated cost of complications, urologic surgery, medication , hospitalization, additional consultations and readmissions.
at 6 months
Duration of hospital stay in days
Time Frame: within 6 months
the hospital stay by day
within 6 months
Rate of recatheterization
Time Frame: in the first 6 months
in the first 6 months
Duration of postoperative return to normal bladder function as assessed by IPSS score
Time Frame: at 1 and 6 months
at 1 and 6 months
Number of additionnal consultations
Time Frame: in the first 6 months
in the first 6 months
Lack of comfort as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra
Time Frame: at 1, 2, 3 and 4 days
visual analogue scale (0-10) for both the abdomen and the urethra (a measure daily until hospital discharge )
at 1, 2, 3 and 4 days
Specific complications
Time Frame: in the first 6 months
in the first 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Pr Jean Luc FAUCHERON, University Clinic of Digestive Surgery and Emergency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 14, 2016

Primary Completion (Actual)

May 18, 2020

Study Completion (Actual)

April 16, 2021

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 38RC14.457

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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