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Completed

NCT Number: NCT00701012

Comparison of Low and High Ligation in the Rectal Cancer

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wakayama Medical University, Second Department of Surgery

Kimiidera, Wakayama, 641-8510, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preservation of nerve fibers around IMA

Procedure

low ligation

Other names: low tie

resection of nerve fibers around IMA

Procedure

high ligation

Other names: high tie

Primary outcomes

  1. Assessment of bowel function

    Time frame: 1 year

Secondary outcomes

  1. comparison of leakage rate

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Wakayama Medical University

Other

Registry information

Official study title

Comparison of Functional Results of High Ligation and Low Ligation After Anterior Resection for Rectal Cancer - Randomized Controlled Trial-

Important dates

Study start
2008
Primary completion
2008
Study completion
2011
First posted
Jun 19, 2008
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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