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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| suprapubic catheterization | Experimental | Intervention:suprapubic catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative. |
|
| transurethral catheterization | Active Comparator | Intervention:transurethral catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suprapubic catheterization | Device | Experimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males |
|
| 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 |
| 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 ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pr Jean Luc FAUCHERON | University Clinic of Digestive Surgery and Emergency | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Grenoble | Grenoble | Auvergne-Rhône-Alpes | 38000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12791005 | Background | Shah EF, Huddy SP. A prospective study of genito-urinary dysfunction after surgery for colorectal cancer. Colorectal Dis. 2001 Mar;3(2):122-5. doi: 10.1046/j.1463-1318.2001.00221.x. | |
| 15846498 | Background | Sterk P, Shekarriz B, Gunter S, Nolde J, Keller R, Bruch HP, Shekarriz H. Voiding and sexual dysfunction after deep rectal resection and total mesorectal excision: prospective study on 52 patients. Int J Colorectal Dis. 2005 Sep;20(5):423-7. doi: 10.1007/s00384-004-0711-4. Epub 2005 Apr 22. |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003559 | Cystostomy |
| ID | Term |
|---|---|
| D010030 | Ostomy |
| D013514 | Surgical Procedures, Operative |
| D014547 | Urinary Diversion |
| D013520 | Urologic Surgical Procedures |
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| transurethral catheterization | Device | Active comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males |
|
| 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 |
| 12195198 | Background | Branagan GW, Moran BJ. Published evidence favors the use of suprapubic catheters in pelvic colorectal surgery. Dis Colon Rectum. 2002 Aug;45(8):1104-8. doi: 10.1007/s10350-004-6368-9. |
| 25189452 | Background | Lee SY, Kang SB, Kim DW, Oh HK, Ihn MH. Risk factors and preventive measures for acute urinary retention after rectal cancer surgery. World J Surg. 2015 Jan;39(1):275-82. doi: 10.1007/s00268-014-2767-9. |
| 7110215 | Background | Platt R, Polk BF, Murdock B, Rosner B. Mortality associated with nosocomial urinary-tract infection. N Engl J Med. 1982 Sep 9;307(11):637-42. doi: 10.1056/NEJM198209093071101. |
| 22691687 | Background | Tambyah PA, Oon J. Catheter-associated urinary tract infection. Curr Opin Infect Dis. 2012 Aug;25(4):365-70. doi: 10.1097/QCO.0b013e32835565cc. |
| 605738 | Background | Rasmussen OV, Korner B, Moller-Sorensen P, Kronborg O. Suprapubic versus urethral bladder drainage following surgery for rectal cancer. Acta Chir Scand. 1977;143(6):371-4. No abstract available. |
| 7136436 | Background | Shapiro J, Hoffmann J, Jersky J. A comparison of suprapubic and transurethral drainage for postoperative urinary retention in general surgical patients. Acta Chir Scand. 1982;148(4):323-7. |
| 3304522 | Background | Sethia KK, Selkon JB, Berry AR, Turner CM, Kettlewell MG, Gough MH. Prospective randomized controlled trial of urethral versus suprapubic catheterization. Br J Surg. 1987 Jul;74(7):624-5. doi: 10.1002/bjs.1800740731. |
| 1938446 | Background | Piergiovanni M, Tschantz P. [Urinary catheterization: transurethral or suprapubic approach?]. Helv Chir Acta. 1991 Jul;58(1-2):201-5. French. |
| 7489167 | Background | O'Kelly TJ, Mathew A, Ross S, Munro A. Optimum method for urinary drainage in major abdominal surgery: a prospective randomized trial of suprapubic versus urethral catheterization. Br J Surg. 1995 Oct;82(10):1367-8. doi: 10.1002/bjs.1800821024. |
| 8876274 | Background | Ratnaval CD, Renwick P, Farouk R, Monson JR, Lee PW. Suprapubic versus transurethral catheterisation of males undergoing pelvic colorectal surgery. Int J Colorectal Dis. 1996;11(4):177-9. doi: 10.1007/s003840050038. |
| 9287924 | Background | Perrin LC, Penfold C, McLeish A. A prospective randomized controlled trial comparing suprapubic with urethral catheterization in rectal surgery. Aust N Z J Surg. 1997 Aug;67(8):554-6. doi: 10.1111/j.1445-2197.1997.tb02037.x. |
| 12789024 | Background | Baan AH, Vermeulen H, van der Meulen J, Bossuyt P, Olszyna D, Gouma DJ. The effect of suprapubic catheterization versus transurethral catheterization after abdominal surgery on urinary tract infection: a randomized controlled trial. Dig Surg. 2003;20(4):290-5. doi: 10.1159/000071693. Epub 2003 Jun 5. |
| 16804872 | Background | McPhail MJ, Abu-Hilal M, Johnson CD. A meta-analysis comparing suprapubic and transurethral catheterization for bladder drainage after abdominal surgery. Br J Surg. 2006 Sep;93(9):1038-44. doi: 10.1002/bjs.5424. |
| 16034924 | Background | Niel-Weise BS, van den Broek PJ. Urinary catheter policies for short-term bladder drainage in adults. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD004203. doi: 10.1002/14651858.CD004203.pub2. |
| 22914481 | Background | Healy EF, Walsh CA, Cotter AM, Walsh SR. Suprapubic compared with transurethral bladder catheterization for gynecologic surgery: a systematic review and meta-analysis. Obstet Gynecol. 2012 Sep;120(3):678-87. doi: 10.1097/AOG.0b013e3182657f0d. |
| 38954131 | Derived | Trilling B, Tidadini F, Lakkis Z, Jafari M, Germain A, Rullier E, Lefevre J, Tuech JJ, Kartheuser A, Leonard D, Prudhomme M, Piessen G, Regimbeau JM, Cotte E, Duprez D, Badic B, Panis Y, Rivoire M, Meunier B, Portier G, Bosson JL, Vilotitch A, Foote A, Caspar Y, Rouanet P, Faucheron JL; GRECCAR study Group. Suprapubic versus transurethral catheterization for bladder drainage in male rectal cancer surgery (GRECCAR10), a randomized clinical trial. Tech Coloproctol. 2024 Jul 2;28(1):77. doi: 10.1007/s10151-024-02950-2. |
| D013519 |
| Urogenital Surgical Procedures |