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

April 25, 2018 updated by: Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350-001
        • Recruiting
        • Fujian Provincial Hospital
        • Contact:
        • Principal Investigator:
          • fangqin xue, M.D.
      • Fuzhou, Fujian, China, 350-014
        • Recruiting
        • Fujian provincial Cancer Hospital
        • Contact:
        • Contact:
          • Chunkang Yang, M.D.
          • Phone Number: +86-13509333116
    • Guangdong
      • Guangzhou, Guangdong, China, 510-515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • TUC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Catherization time
Time Frame: 6 days
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of catheterization
Time Frame: 30 days
30 days
Catheter-Associated Urinary Tract Infection
Time Frame: 30 days
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.
5 days
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.
30 days
Time to first ambulation
Time Frame: 7 days
7 days
Duration of hospital stay
Time Frame: 30 days
30 days
Urinary extravasation
Time Frame: 30 days
30 days
Hematuria
Time Frame: 30 days
30 days
Catheter obstruction
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Fujian Cancer Hospital
Fujian Provincial Hospital

Investigators

  • Principal Investigator: Guoxin Li, M.D., Ph.D., Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (Estimate)

April 5, 2016

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPCCVC-TUC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Cancer

Clinical Trials on Suprapubic catheterization using central venous catheter(CVC-2 7F)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe