Clinical trial · Interventional
Multicenter Study on Suprapubic Catheterization Versus Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer
Multicenter Study on Comparing Suprapubic Catheterization Versus Traditional Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer
- 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)
Compared with traditional open proctectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its long-term oncologic outcomes have been demonstrated. However, the rate of urinary dysfunction after rectal cancer surgery was about 19-38% because of mesorectal excision. The type of drainage is unclear. Some studies show that the rates of urinary tract infection, second catheterization, and urinary symptom are lower with suprapubic catheterization (SPC) than with transurethral catheterization (TUC). Moreover，SPC allows for testing the bladder voiding without drainage removal. Furthermore，SPC using central venous catheter(CVC) is less invasive. Currently, there is lack of randomized controlled trial(RCT) to compare SPC with TUC. Therefore, investigators perform this prospective randomized trial to compare SPC using CVC with TUC in laparoscopic surgery for rectal cancer.
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Suprapubic catheterization using central venous catheter(CVC-2 7F) | Device | — | UNRESOLVED |
| Transurethral catheterization using Foley catheter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Suprapubic Catheterization
- description
- Suprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients in this group.
- interventionNames
- Device: Suprapubic catheterization using central venous catheter(CVC-2 7F)
- type
- ACTIVE_COMPARATOR
- label
- Transurethral Catheterization
- description
- Transurethral catheterization using Foley catheter will be performed for patients in this group.
- interventionNames
- Device: Transurethral catheterization using Foley catheter
Primary outcomes (1)
- measure
- Catherization time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 18 years * Pathological rectal carcinoma * Male patients * Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale * ASA (American Society of Anesthesiology) score class I, II, or III * Laparoscopic surgery for rectal cancer * Written informed consent Exclusion Criteria: * Emergency surgery due to complication (obstruction or perforation) caused by rectal cancer * Preoperative T4b according to the 7th Edition of AJCC Cancer Staging Manual * Basic diseases of urinary system (urinary bladder stones and tumors, prostate cancer, neurogenic bladder, urethral stricture) that affect voiding function * History of previous pelvic surgery * Severe mental disease
References
Publications (7)
- BACKGROUNDBonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, Lacy AM, Bemelman WA, Andersson J, Angenete E, Rosenberg J, Fuerst A, Haglind E; COLOR II Study Group. A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015 Apr 2;372(14):1324-32. doi: 10.1056/NEJMoa1414882. PMID 25830422
- BACKGROUNDJayne DG, Brown JM, Thorpe H, Walker J, Quirke P, Guillou PJ. Bladder and sexual function following resection for rectal cancer in a randomized clinical trial of laparoscopic versus open technique. Br J Surg. 2005 Sep;92(9):1124-32. doi: 10.1002/bjs.4989. PMID 15997446
- BACKGROUNDMaurer CA, Z'Graggen K, Renzulli P, Schilling MK, Netzer P, Buchler MW. Total mesorectal excision preserves male genital function compared with conventional rectal cancer surgery. Br J Surg. 2001 Nov;88(11):1501-5. doi: 10.1046/j.0007-1323.2001.01904.x. PMID 11683749
- BACKGROUNDBouchet-Doumenq C, Lefevre JH, Bennis M, Chafai N, Tiret E, Parc Y. Management of postoperative bladder emptying after proctectomy in men for rectal cancer. A retrospective study of 190 consecutive patients. Int J Colorectal Dis. 2016 Mar;31(3):511-8. doi: 10.1007/s00384-015-2471-8. Epub 2015 Dec 22. PMID 26694925
- BACKGROUNDSethia 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
- BACKGROUNDRatnaval 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
- BACKGROUNDPerrin 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.