Multicenter Study on Suprapubic Catheterization Versus Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer
NCT ID: NCT02728427
Last Updated: 2018-04-26
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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2016-04-30
2018-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Suprapubic Catheterization
Suprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients in this group.
Suprapubic catheterization using central venous catheter(CVC-2 7F)
Suprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients after laparoscopic surgery for rectal cancer.Suprapubic catheterization is inserted at the end of the procedure. It will be clamped depending on surgeon's specific instruction and removed if the urinary residual is less than 50 cc.
Transurethral Catheterization
Transurethral catheterization using Foley catheter will be performed for patients in this group.
Transurethral catheterization using Foley catheter
Traditional transurethral catheterization using Foley catheter will be performed for patients.The catheterization is removed on day 5 in patients without complication.
Interventions
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Suprapubic catheterization using central venous catheter(CVC-2 7F)
Suprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients after laparoscopic surgery for rectal cancer.Suprapubic catheterization is inserted at the end of the procedure. It will be clamped depending on surgeon's specific instruction and removed if the urinary residual is less than 50 cc.
Transurethral catheterization using Foley catheter
Traditional transurethral catheterization using Foley catheter will be performed for patients.The catheterization is removed on day 5 in patients without complication.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Fujian Cancer Hospital
OTHER_GOV
Fujian Provincial Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Principal Investigators
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Guoxin Li, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China
Locations
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Fujian Provincial Hospital
Fuzhou, Fujian, China
Fujian Provincial cancer Hospital
Fuzhou, Fujian, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Chunkang Yang, M.D.
Role: backup
References
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Bonjer 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.
Jayne 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.
Maurer 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.
Bouchet-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.
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.
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.
Related Links
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Southern Medical University, China
Nanfang Hospital, China
Chinese Anti-Cancer Association
Other Identifiers
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SPCCVC-TUC
Identifier Type: -
Identifier Source: org_study_id
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