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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922647
Recruitment Status : Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE February 4, 2016
First Posted Date  ICMJE October 4, 2016
Last Update Posted Date January 28, 2020
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
  • 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 ]
  • 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 )
  • Participants morbidity and mortality as assessed by Dindo and Clavien classification [ Time Frame: 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.
  • 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.
  • Duration of hospital stay in days [ Time Frame: within 6 months ]
    the hospital stay by day
  • Rate of recatheterization [ Time Frame: 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 ]
  • Number of additionnal consultations [ Time Frame: 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 )
  • Specific complications [ Time Frame: in the first 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males
Official Title  ICMJE Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males
Brief Summary The urpose 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Infection
  • Cancer
Intervention  ICMJE
  • Device: suprapubic catheterization
    Experimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males
  • Device: transurethral catheterization
    Active comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males
Study Arms  ICMJE
  • Experimental: suprapubic catheterization
    Intervention:suprapubic catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative.
    Intervention: Device: suprapubic catheterization
  • Active Comparator: transurethral catheterization
    Intervention:transurethral catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative.
    Intervention: Device: transurethral catheterization
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 24, 2020)
240
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2016)
220
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02922647
Other Study ID Numbers  ICMJE 38RC14.457
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pr Jean Luc FAUCHERON University Clinic of Digestive Surgery and Emergency
PRS Account University Hospital, Grenoble
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP