MSSPC: Multicenter Study on Suprapubic Catheterization Versus Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Suprapubic Catheterization Suprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients in this group. |
Device: 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.
Other Names:
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| Active Comparator: Transurethral Catheterization Transurethral catheterization using Foley catheter will be performed for patients in this group. |
Device: 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 Names:
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Outcome Measures
Primary Outcome Measures
- Catherization time [6 days]
Secondary Outcome Measures
- Number of catheterization [30 days]
- Catheter-Associated Urinary Tract Infection [30 days]
- Pain score [5 days]
Postoperative pain is recorded using the visual analog scale (VAS) pain score tool from the surgery day to the fifth day after surgery.
- International Prostatic Symptom Score [30 days]
The International Prostatic Symptom Score is recorded from the day before surgery to the 30th day after surgery.
- Time to first ambulation [7 days]
- Duration of hospital stay [30 days]
- Urinary extravasation [30 days]
- Hematuria [30 days]
- Catheter obstruction [30 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age over 18 years
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Pathological rectal carcinoma
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Male patients
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Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
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ASA (American Society of Anesthesiology) score class I, II, or III
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Laparoscopic surgery for rectal cancer
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Written informed consent
Exclusion Criteria:
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Emergency surgery due to complication (obstruction or perforation) caused by rectal cancer
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Preoperative T4b according to the 7th Edition of AJCC Cancer Staging Manual
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Basic diseases of urinary system (urinary bladder stones and tumors, prostate cancer, neurogenic bladder, urethral stricture) that affect voiding function
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History of previous pelvic surgery
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Severe mental disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fujian Provincial Hospital | Fuzhou | Fujian | China | 350-001 |
| 2 | Fujian Provincial cancer Hospital | Fuzhou | Fujian | China | 350-014 |
| 3 | Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | China | 510-515 |
Sponsors and Collaborators
- Nanfang Hospital of Southern Medical University
- Fujian Cancer Hospital
- Fujian Provincial Hospital
Investigators
- Principal Investigator: Guoxin Li, M.D., Ph.D., Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- Maurer CA, Z'Graggen K, Renzulli P, Schilling MK, Netzer P, Büchler MW. Total mesorectal excision preserves male genital function compared with conventional rectal cancer surgery. Br J Surg. 2001 Nov;88(11):1501-5.
- 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.
- 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.
- 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.
- SPCCVC-TUC