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

NCT02922647 | Completed DMC

• 1 other identifier: 38RC14.457
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infection; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

  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

  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

  at 6 months

Study Arms (2)

suprapubic catheterization

EXPERIMENTAL

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

Device: suprapubic catheterization

transurethral catheterization

ACTIVE COMPARATOR

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

Device: transurethral catheterization

Interventions

suprapubic catheterization DEVICE

Experimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males

suprapubic catheterization

transurethral catheterization DEVICE

Active comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males

transurethral catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, Auvergne-Rhône-Alpes, 38000, France

Location

Related Publications (18)

• 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.

  PMID: 12791005 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.

  PMID: 15846498 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.

  PMID: 12195198 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.

  PMID: 25189452 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.

  PMID: 7110215 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.

  PMID: 22691687 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.

  PMID: 605738 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.

  PMID: 7136436 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.

  PMID: 3304522 BACKGROUND

• Piergiovanni M, Tschantz P. [Urinary catheterization: transurethral or suprapubic approach?]. Helv Chir Acta. 1991 Jul;58(1-2):201-5. French.

  PMID: 1938446 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.

  PMID: 7489167 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.

  PMID: 8876274 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.

  PMID: 9287924 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.

  PMID: 12789024 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.

  PMID: 16804872 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.

  PMID: 16034924 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.

  PMID: 22914481 BACKGROUND

• 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.

  PMID: 38954131 DERIVED

MeSH Terms

Conditions

Infections; Neoplasms

Interventions

Cystostomy

Intervention Hierarchy (Ancestors)

Ostomy; Surgical Procedures, Operative; Urinary Diversion; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Pr Jean Luc FAUCHERON

  University Clinic of Digestive Surgery and Emergency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: October 4, 2016
• Study Start: October 14, 2016
• Primary Completion: May 18, 2020
• Study Completion: April 16, 2021
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

FR (1)