Comparison of Low and High Ligation in the Rectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by Wakayama Medical University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Wakayama Medical University

ClinicalTrials.gov Identifier:

NCT00701012

First received: June 17, 2008

Last updated: February 17, 2010

Last verified: January 2010

History of Changes

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:

MedlinePlus related topics: Cancer Dietary Fiber

U.S. FDA Resources

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 ]

Estimated Enrollment:	100
Study Start Date:	January 2008
Estimated 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

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

Contacts

Contact: Hiroki Yamaue

+81-73-441-0613

yamaue-h@wakayama-med.ac.jp

Locations

Japan
Wakayama Medical University, Second Department of Surgery	Recruiting
811-1 Kimiidera, Wakayama, Japan, 641-8510
Contact: Hiroki Yamaue +81-73-441-0613 yamaue-h@wakayama-med.ac.jp
Principal Investigator: Kenji Matsuda, MD

Sponsors and Collaborators

Wakayama Medical University

Investigators

Study Director:

Hiroki Yamaue, MD

Second Departmant of Surgery, Wakayama Medical University

More Information

Publications:

Uehara K, Yamamoto S, Fujita S, Akasu T, Moriya Y. Impact of upward lymph node dissection on survival rates in advanced lower rectal carcinoma. Dig Surg. 2007;24(5):375-81. Epub 2007 Aug 4.

Nelson H, Petrelli N, Carlin A, Couture J, Fleshman J, Guillem J, Miedema B, Ota D, Sargent D; National Cancer Institute Expert Panel. Guidelines 2000 for colon and rectal cancer surgery. J Natl Cancer Inst. 2001 Apr 18;93(8):583-96.

Surtees P, Ritchie JK, Phillips RK. High versus low ligation of the inferior mesenteric artery in rectal cancer. Br J Surg. 1990 Jun;77(6):618-21.

Corder AP, Karanjia ND, Williams JD, Heald RJ. Flush aortic tie versus selective preservation of the ascending left colic artery in low anterior resection for rectal carcinoma. Br J Surg. 1992 Jul;79(7):680-2.

Koda K, Saito N, Seike K, Shimizu K, Kosugi C, Miyazaki M. Denervation of the neorectum as a potential cause of defecatory disorder following low anterior resection for rectal cancer. Dis Colon Rectum. 2005 Feb;48(2):210-7.

Iizuka I, Koda K, Seike K, Shimizu K, Takami Y, Fukuda H, Tsuchida D, Oda K, Takiguchi N, Miyazaki M. Defecatory malfunction caused by motility disorder of the neorectum after anterior resection for rectal cancer. Am J Surg. 2004 Aug;188(2):176-80.

Adachi Y, Kakisako K, Sato K, Shiraishi N, Miyahara M, Kitano S. Factors influencing bowel function after low anterior resection and sigmoid colectomy. Hepatogastroenterology. 2000 Jan-Feb;47(31):155-8.

Responsible Party:	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:	February 17, 2010
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 June 17, 2013

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