Comparison of Low and High Ligation in the Rectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hiroki Yamaue, Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT00701012
First received: June 17, 2008
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to evaluate the defecatory function when nerve fibers around the inferior mesenteric artery(IMA) and left colic artery(LCA) are preserved(so called low ligation ) or not(high ligation) in the rectosigmoid and rectal cancer surgery.


Condition Intervention
Rectal Cancer
Procedure: preservation of nerve fibers around IMA
Procedure: resection of nerve fibers around IMA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Functional Results of High Ligation and Low Ligation After Anterior Resection for Rectal Cancer - Randomized Controlled Trial-

Resource links provided by NLM:


Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • Assessment of bowel function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • comparison of leakage rate [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
low ligation, which the IMA is ligated below the origin of the left colic artery
Procedure: preservation of nerve fibers around IMA
low ligation
Other Name: low tie
Active Comparator: 2
high ligation, which the IMA is ligated at its origin from the aorta
Procedure: resection of nerve fibers around IMA
high ligation
Other Name: high tie

Detailed Description:

Fecal incontinence after anterior resection are often observed. Whether or not postoperative bowel function is influenced by the preservation of nerve fibers around the root of IMA and LCA (low ligation) is still unknown. So in this randomized controlled trial, we evaluate the efficacy of low ligation in terms of the bowel function.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On the basis of whether anterior resection was anticipated at WMUH for rectosigmoid and rectal cancer, and appropriate informed consent was obtained.

Exclusion Criteria:

  • Patients who could not respond to medical interview for own bowel function
  • Patients without an informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701012

Locations
Japan
Wakayama Medical University, Second Department of Surgery
Kimiidera, Wakayama, Japan, 641-8510
Sponsors and Collaborators
Wakayama Medical University
Investigators
Study Director: Hiroki Yamaue, MD Second Departmant of Surgery, Wakayama Medical University
  More Information

Publications:
Responsible Party: Hiroki Yamaue, Second Department of Surgery, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT00701012     History of Changes
Other Study ID Numbers: WMU512
Study First Received: June 17, 2008
Last Updated: December 17, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Wakayama Medical University:
low or high ligation

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 16, 2014