Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males
NCT ID: NCT02922647
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2016-10-14
2021-04-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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suprapubic catheterization
Intervention:suprapubic catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative.
suprapubic catheterization
Experimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males
transurethral catheterization
Intervention:transurethral catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative.
transurethral catheterization
Active comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males
Interventions
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suprapubic catheterization
Experimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males
transurethral catheterization
Active comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Pr Jean Luc FAUCHERON
Role: PRINCIPAL_INVESTIGATOR
University Clinic of Digestive Surgery and Emergency
Locations
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University Hospital Grenoble
Grenoble, Auvergne-Rhône-Alpes, France
Countries
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References
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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.
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.
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.
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.
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.
Tambyah PA, Oon J. Catheter-associated urinary tract infection. Curr Opin Infect Dis. 2012 Aug;25(4):365-70. doi: 10.1097/QCO.0b013e32835565cc.
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.
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.
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.
Piergiovanni M, Tschantz P. [Urinary catheterization: transurethral or suprapubic approach?]. Helv Chir Acta. 1991 Jul;58(1-2):201-5. French.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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38RC14.457
Identifier Type: -
Identifier Source: org_study_id
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