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Comparison of Low and High Ligation in the Rectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00701012
First Posted: June 19, 2008
Last Update Posted: December 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hiroki Yamaue, Wakayama Medical University
  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
Intervention Model: Parallel Assignment
Masking: Double (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-

Further study details as provided by Hiroki Yamaue, Wakayama Medical University:

Primary Outcome Measures:
  • Assessment of bowel function [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • comparison of leakage rate [ Time Frame: 2 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hiroki Yamaue, Second Department of Surgery, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT00701012     History of Changes
Other Study ID Numbers: WMU512
First Submitted: June 17, 2008
First Posted: June 19, 2008
Last Update Posted: December 18, 2013
Last Verified: December 2013

Keywords provided by Hiroki Yamaue, 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