Clinical trial NCT02922647: Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males
Official title: Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Cancer
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 240
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of participants with urinary tract infection when using suprapubic versus transurethral catheterization as assessed by significant bacteriuria and pyuria
timeFrame: four days postoperative
Secondary outcomes:
measure: 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
timeFrame: 1 month
measure: Pain as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra
timeFrame: at 1, 2, 3 and 4 days
measure: Participants morbidity and mortality as assessed by Dindo and Clavien classification
timeFrame: at 1 month and 6 months
measure: Rate of satisfaction for participants as assessed by questionnaries (Fact-C and EQ-5D-3L
timeFrame: at 30 days and 6 months
measure: 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
timeFrame: at 6 months
measure: Duration of hospital stay in days
timeFrame: within 6 months
measure: Rate of recatheterization
timeFrame: in the first 6 months
measure: Duration of postoperative return to normal bladder function as assessed by IPSS score
timeFrame: at 1 and 6 months
measure: Number of additionnal consultations
timeFrame: in the first 6 months
measure: Lack of comfort as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra
timeFrame: at 1, 2, 3 and 4 days
measure: Specific complications
timeFrame: in the first 6 months
Other outcomes:
Locations:
city: Grenoble,
country: France
facility: University Hospital Grenoble
state: Rhone Alpes
Study officials:
affiliation: University Clinic of Digestive Surgery and Emergency
name: Pr Jean Luc FAUCHERON
role: PRINCIPAL_INVESTIGATOR
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