Cancer, Infection
Conditions
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.
Interventions
DEVICEsuprapubic catheterization
Experimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males
DEVICEtransurethral catheterization
Active comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with urinary tract infection when using suprapubic versus transurethral catheterization as assessed by significant bacteriuria and pyuria | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra | 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 | at 1 month and 6 months | — |
| Rate of satisfaction for participants as assessed by questionnaries (Fact-C and EQ-5D-3L | 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 | at 6 months | Estimated cost of complications, urologic surgery, medication , hospitalization, additional consultations and readmissions. |
| Duration of hospital stay in days | within 6 months | the hospital stay by day |
| 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 | 1 month | — |
| Duration of postoperative return to normal bladder function as assessed by IPSS score | at 1 and 6 months | — |
| Number of additionnal consultations | in the first 6 months | — |
| Lack of comfort as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra | 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 | in the first 6 months | — |
| Rate of recatheterization | in the first 6 months | — |
Countries
France
Outcome results
None listed