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

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Surgery; Rectal Cancer

Treatments: Device: Suprapubic catheterization using central venous catheter(CVC-2 7F); Device: Transurethral catheterization using Foley catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02728427

SPCCVC-TUC

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Suprapubic Catheterization

Experimental group

Description:

Suprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients in this group.

Treatment:

Device: Suprapubic catheterization using central venous catheter(CVC-2 7F)

Transurethral Catheterization

Active Comparator group

Description:

Transurethral catheterization using Foley catheter will be performed for patients in this group.

Treatment:

Device: Transurethral catheterization using Foley catheter