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

University Hospital, Grenoble1 site in 1 country240 target enrollmentOctober 14, 2016

ConditionsInfection Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infection
Sponsor: University Hospital, Grenoble
Enrollment: 240
Locations: 1
Primary Endpoint: Number of participants with urinary tract infection when using suprapubic versus transurethral catheterization as assessed by significant bacteriuria and pyuria
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 14, 2016

End Date

April 16, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University Hospital, Grenoble

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

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 Outcomes

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)
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)
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)
Duration of hospital stay in days(within 6 months)
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)