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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infection, Cancer

Intervention / Treatment
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* Device: suprapubic catheterization
* Device: transurethral catheterization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: suprapubic catheterization<br>Intervention:suprapubic catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative. | Device: suprapubic catheterization<br>* Experimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males<br>|
| Active Comparator: transurethral catheterization<br>Intervention:transurethral catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative. | Device: transurethral catheterization<br>* Active comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | four days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 ) | at 1, 2, 3 and 4 days | 
| 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 | 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. | 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. | at 6 months | 
| Duration of hospital stay in days | the hospital stay by day | within 6 months | 
| Rate of recatheterization |  | in the first 6 months | 
| 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 | visual analogue scale (0-10) for both the abdomen and the urethra (a measure daily until hospital discharge ) | at 1, 2, 3 and 4 days | 
| Specific complications |  | in the first 6 months |