Multicenter Study on Suprapubic Catheterization Versus Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer (MSSPC)
|ClinicalTrials.gov Identifier: NCT02728427|
Recruitment Status : Unknown
Verified April 2018 by Nanfang Hospital of Southern Medical University.
Recruitment status was: Recruiting
First Posted : April 5, 2016
Last Update Posted : April 26, 2018
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|
|Rectal Cancer Surgery||Device: Suprapubic catheterization using central venous catheter(CVC-2 7F) Device: Transurethral catheterization using Foley catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Study on Comparing Suprapubic Catheterization Versus Traditional Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
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 Name: SPCCVC
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 Name: TUC
- Catherization time [ Time Frame: 6 days ]
- Number of catheterization [ Time Frame: 30 days ]
- Catheter-Associated Urinary Tract Infection [ Time Frame: 30 days ]
- Pain score [ Time Frame: 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 [ Time Frame: 30 days ]The International Prostatic Symptom Score is recorded from the day before surgery to the 30th day after surgery.
- Time to first ambulation [ Time Frame: 7 days ]
- Duration of hospital stay [ Time Frame: 30 days ]
- Urinary extravasation [ Time Frame: 30 days ]
- Hematuria [ Time Frame: 30 days ]
- Catheter obstruction [ Time Frame: 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728427
|Contact: Guoxin Li, M.D., Ph.D.||+firstname.lastname@example.org|
|Contact: jun Yan, M.D., Ph.D.||+email@example.com|
|Fujian Provincial Hospital||Recruiting|
|Fuzhou, Fujian, China, 350-001|
|Contact: Fangqin Xue, M.D. +86-137-9995-9360 firstname.lastname@example.org|
|Principal Investigator: fangqin xue, M.D.|
|Fujian Provincial cancer Hospital||Recruiting|
|Fuzhou, Fujian, China, 350-014|
|Contact: Weidong Zang, M.D. +86-13805066578 email@example.com|
|Contact: Chunkang Yang, M.D. +86-13509333116|
|Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510-515|
|Contact: Guoxin Li, M.D., Ph.D. +86-138-0277-1450 firstname.lastname@example.org|
|Contact: Jun Yan, M.D., Ph.D. +86-138-2506-6546 email@example.com|
|Principal Investigator:||Guoxin Li, M.D., Ph.D.||Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China|