Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males
- Conditions
- CancerInfection
- Interventions
- Device: suprapubic catheterizationDevice: transurethral catheterization
- Registration Number
- NCT02922647
- Lead Sponsor
- University Hospital, Grenoble
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 240
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description suprapubic catheterization suprapubic catheterization Intervention:suprapubic catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative. transurethral catheterization transurethral catheterization Intervention:transurethral catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Participants morbidity and mortality as assessed by Dindo and Clavien classification at 1 month 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.
Specific complications in the first 6 months 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 )
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 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.
Duration of hospital stay in days within 6 months the hospital stay by day
Rate of recatheterization 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 )
Trial Locations
- Locations (1)
University Hospital Grenoble
🇫🇷Grenoble,, Rhone Alpes, France