Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males (GRECCAR10)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Infection; Cancer

Treatments: Device: suprapubic catheterization; Device: transurethral catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT02922647

38RC14.457

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

suprapubic catheterization

Experimental group

Description:

Intervention:suprapubic catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative.

Treatment:

Device: suprapubic catheterization

transurethral catheterization

Active Comparator group

Description:

Intervention:transurethral catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative.

Treatment:

Device: transurethral catheterization