NCT02728427

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer
• Surgery

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2016-04-05
• Last updated: 2018-04-26

Locations

3 sites across 1 country: China