Multicenter Study on Suprapubic Catheterization Versus Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer

Not Applicable

• Conditions: Surgery; Rectal Cancer
• Interventions: Device: Transurethral catheterization using Foley catheter; Device: Suprapubic catheterization using central venous catheter(CVC-2 7F)

• Registration Number: NCT02728427
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-22
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-05
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-04-26
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transurethral Catheterization	Transurethral catheterization using Foley catheter	Transurethral catheterization using Foley catheter will be performed for patients in this group.
Suprapubic Catheterization	Suprapubic catheterization using central venous catheter(CVC-2 7F)	Suprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients in this group.

Primary Outcome Measures

Name	Time	Method
Catherization time	6 days

Secondary Outcome Measures

Name	Time	Method
Time to first ambulation	7 days
Duration of hospital stay	30 days
Number of catheterization	30 days
Catheter obstruction	30 days
Catheter-Associated Urinary Tract Infection	30 days
International Prostatic Symptom Score	30 days	The International Prostatic Symptom Score is recorded from the day before surgery to the 30th day after surgery.
Hematuria	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.
Urinary extravasation	30 days

Trial Locations

Locations (3)

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Fujian Provincial cancer Hospital; 🇨🇳 Fuzhou, Fujian, China