Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males (GRECCAR10)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02922647|
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infection Cancer||Device: suprapubic catheterization Device: transurethral catheterization||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: suprapubic catheterization
Intervention:suprapubic catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative.
Device: suprapubic catheterization
Experimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males
Active Comparator: transurethral catheterization
Intervention:transurethral catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative.
Device: transurethral catheterization
Active comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males
- 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.
- 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 [ Time Frame: 1 month ]
- Pain as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra [ Time Frame: 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 [ Time Frame: at 1 month and 6 months ]
- Rate of satisfaction for participants as assessed by questionnaries (Fact-C and EQ-5D-3L [ Time Frame: 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 [ Time Frame: at 6 months ]Estimated cost of complications, urologic surgery, medication , hospitalization, additional consultations and readmissions.
- Duration of hospital stay in days [ Time Frame: within 6 months ]the hospital stay by day
- Rate of recatheterization [ Time Frame: in the first 6 months ]
- Duration of postoperative return to normal bladder function as assessed by IPSS score [ Time Frame: at 1 and 6 months ]
- Number of additionnal consultations [ Time Frame: in the first 6 months ]
- Lack of comfort as assessed by visual analogue scale (0 to 10 score) for abdomen and urethra [ Time Frame: 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 [ Time Frame: in the first 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922647
|Contact: Fatah TIDADINI||04 76 76 70 79||FTidadini@chu-grenoble.fr|
|University Hospital Grenoble||Recruiting|
|Grenoble,, Rhone Alpes, France, 38000|
|Contact: Pr Jean Luc FAUCHERON, Phd 04 76 76 53 71 JLFaucheron@chu-grenoble.fr|
|Contact: Fatah TIDADINI 04 76 76 70 79 FTidadini@chu-grenoble.fr|
|Principal Investigator:||Pr Jean Luc FAUCHERON||University Clinic of Digestive Surgery and Emergency|