Clinical trial · Interventional
Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males
NCT02922647CI-TRIAL-00059800GRECCAR10completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| suprapubic catheterization | Device | — | UNRESOLVED |
| transurethral catheterization | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- suprapubic catheterization
- description
- Intervention:suprapubic catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative.
- interventionNames
- Device: suprapubic catheterization
- type
- ACTIVE_COMPARATOR
- label
- transurethral catheterization
- description
- Intervention:transurethral catheterization after rectal resection with low anastomosis. Evaluate the urinary tract infection rate on the four days postoperative.
- interventionNames
- Device: transurethral catheterization
Primary outcomes (1)
- measure
- Number of participants with urinary tract infection when using suprapubic versus transurethral catheterization as assessed by significant bacteriuria and pyuria
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (18)
- BACKGROUNDShah 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
- BACKGROUNDSterk 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
- BACKGROUNDBranagan 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
- BACKGROUNDLee 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
- BACKGROUNDPlatt 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
- BACKGROUNDTambyah 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
- BACKGROUNDRasmussen 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
- BACKGROUNDShapiro 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.