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Comparison of Low and High Ligation in the Rectal Cancer

NCT ID: NCT00701012

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rectal Cancer

Keywords

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low or high ligation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1

low ligation, which the IMA is ligated below the origin of the left colic artery

Group Type EXPERIMENTAL

preservation of nerve fibers around IMA

Intervention Type PROCEDURE

low ligation

2

high ligation, which the IMA is ligated at its origin from the aorta

Group Type ACTIVE_COMPARATOR

resection of nerve fibers around IMA

Intervention Type PROCEDURE

high ligation

Interventions

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preservation of nerve fibers around IMA

low ligation

Intervention Type PROCEDURE

resection of nerve fibers around IMA

high ligation

Intervention Type PROCEDURE

Other Intervention Names

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low tie high tie

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wakayama Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hiroki Yamaue

Second Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hiroki Yamaue, MD

Role: STUDY_DIRECTOR

Second Departmant of Surgery, Wakayama Medical University

Locations

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Wakayama Medical University, Second Department of Surgery

Kimiidera, Wakayama, Japan

Site Status

Countries

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Japan

References

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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. doi: 10.1159/000107779. Epub 2007 Aug 4.

Reference Type BACKGROUND
PMID: 17785983 (View on PubMed)

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. doi: 10.1093/jnci/93.8.583.

Reference Type BACKGROUND
PMID: 11309435 (View on PubMed)

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. doi: 10.1002/bjs.1800770607.

Reference Type BACKGROUND
PMID: 2383724 (View on PubMed)

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. doi: 10.1002/bjs.1800790730.

Reference Type BACKGROUND
PMID: 1643485 (View on PubMed)

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. doi: 10.1007/s10350-004-0814-6.

Reference Type BACKGROUND
PMID: 15711859 (View on PubMed)

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. doi: 10.1016/j.amjsurg.2003.12.064.

Reference Type BACKGROUND
PMID: 15249246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10690600 (View on PubMed)

Matsuda K, Yokoyama S, Hotta T, Takifuji K, Watanabe T, Tamura K, Mitani Y, Iwamoto H, Mizumoto Y, Yamaue H. Oncological Outcomes following Rectal Cancer Surgery with High or Low Ligation of the Inferior Mesenteric Artery. Gastrointest Tumors. 2017 Sep;4(1-2):45-52. doi: 10.1159/000477805. Epub 2017 Jul 5.

Reference Type DERIVED
PMID: 29071264 (View on PubMed)

Matsuda K, Hotta T, Takifuji K, Yokoyama S, Oku Y, Watanabe T, Mitani Y, Ieda J, Mizumoto Y, Yamaue H. Randomized clinical trial of defaecatory function after anterior resection for rectal cancer with high versus low ligation of the inferior mesenteric artery. Br J Surg. 2015 Apr;102(5):501-8. doi: 10.1002/bjs.9739.

Reference Type DERIVED
PMID: 25764287 (View on PubMed)

Other Identifiers

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WMU512

Identifier Type: -

Identifier Source: org_study_id