Clinical trial NCT02728427: Multicenter Study on Suprapubic Catheterization Versus Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer
Official title: Multicenter Study on Comparing Suprapubic Catheterization Versus Traditional Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Surgery
Keywords: Suprapubic Catheterization
Transurethral Catheterization
Rectal Cancer
Laparoscopic Surgery
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Fujian Cancer Hospital
name: Fujian Provincial Hospital
First posted: 2016-04-05
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Catherization time
timeFrame: 6 days
Secondary outcomes:
measure: Number of catheterization
timeFrame: 30 days
measure: Catheter-Associated Urinary Tract Infection
timeFrame: 30 days
measure: Pain score
timeFrame: 5 days
measure: International Prostatic Symptom Score
timeFrame: 30 days
measure: Time to first ambulation
timeFrame: 7 days
measure: Duration of hospital stay
timeFrame: 30 days
measure: Urinary extravasation
timeFrame: 30 days
measure: Hematuria
timeFrame: 30 days
measure: Catheter obstruction
timeFrame: 30 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China
name: Guoxin Li, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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