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

Cancer Clinical Trial

— GRECCAR10  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922647
• Other study ID #: 38RC14.457
• Status: Completed
• Phase: N/A
• Start date: October 14, 2016
• Est. completion date: April 16, 2021

Study information

• Verified date: July 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 16, 2021
• Est. primary completion date: May 18, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Infection

Intervention

Device:
• 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

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble,	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (17)

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. Epub 2003 Jun 5. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Niël-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. Review. Update in: Cochrane Database Syst Rev. 2015;12:CD004203. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Rasmussen OV, Korner B, Møller-Sørensen P, Kronborg O. Suprapubic versus urethral bladder drainage following surgery for rectal cancer. Acta Chir Scand. 1977;143(6):371-4. — View Citation

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. — View Citation

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. — View Citation

Shah EF, Huddy SP. A prospective study of genito-urinary dysfunction after surgery for colorectal cancer. Colorectal Dis. 2001 Mar;3(2):122-5. — View Citation

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. — View Citation

Sterk P, Shekarriz B, Günter 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. Epub 2005 Apr 22. — View Citation

Tambyah PA, Oon J. Catheter-associated urinary tract infection. Curr Opin Infect Dis. 2012 Aug;25(4):365-70. doi: 10.1097/QCO.0b013e32835565cc. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Participants morbidity and mortality as assessed by Dindo and Clavien classification		at 1 month and 6 months
Secondary	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
Secondary	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
Secondary	Duration of hospital stay in days	the hospital stay by day	within 6 months
Secondary	Rate of recatheterization		in the first 6 months
Secondary	Duration of postoperative return to normal bladder function as assessed by IPSS score		at 1 and 6 months
Secondary	Number of additionnal consultations		in the first 6 months
Secondary	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
Secondary	Specific complications		in the first 6 months