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

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ClinicalTrials.gov Identifier: NCT02922647
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Infection Cancer Device: suprapubic catheterization Device: transurethral catheterization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 )

  3. Participants morbidity and mortality as assessed by Dindo and Clavien classification [ Time Frame: at 1 month and 6 months ]
  4. 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.

  5. 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.

  6. Duration of hospital stay in days [ Time Frame: within 6 months ]
    the hospital stay by day

  7. Rate of recatheterization [ Time Frame: in the first 6 months ]
  8. Duration of postoperative return to normal bladder function as assessed by IPSS score [ Time Frame: at 1 and 6 months ]
  9. Number of additionnal consultations [ Time Frame: in the first 6 months ]
  10. 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 )

  11. Specific complications [ Time Frame: in the first 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922647


Contacts
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Contact: Fatah TIDADINI 04 76 76 70 79 FTidadini@chu-grenoble.fr

Locations
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France
University Hospital Grenoble Recruiting
Grenoble,, Rhone Alpes, France, 38000
Contact: Pr Jean Luc FAUCHERON, Phd    04 76 76 53 71    JLFaucheron@chu-grenoble.fr   
Contact: Fatah TIDADINI    04 76 76 70 79    FTidadini@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Pr Jean Luc FAUCHERON University Clinic of Digestive Surgery and Emergency

Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02922647     History of Changes
Other Study ID Numbers: 38RC14.457
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018