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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
240
Experimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males
Active comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males
University Hospital Grenoble
Grenoble, Auvergne-Rhône-Alpes, France
Number of participants with urinary tract infection when using suprapubic versus transurethral catheterization as assessed by significant bacteriuria and pyuria
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.
Time frame: four days postoperative
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
visual analogue scale (0-10) for both the abdomen and the urethra (a measure daily until hospital discharge )
Time frame: 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
Rate of satisfaction for participants as assessed by questionnaries (Fact-C and EQ-5D-3L
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.
Time frame: 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
Estimated cost of complications, urologic surgery, medication , hospitalization, additional consultations and readmissions.
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Time frame: at 6 months
Duration of hospital stay in days
the hospital stay by day
Time frame: within 6 months
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
visual analogue scale (0-10) for both the abdomen and the urethra (a measure daily until hospital discharge )
Time frame: at 1, 2, 3 and 4 days
Specific complications
Time frame: in the first 6 months