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Comparison of Low and High Ligation in the Rectal Cancer

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
preservation of nerve fibers around IMA
resection of nerve fibers around IMA
Sponsored by
Wakayama Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring low or high ligation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wakayama Medical University, Second Department of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Assessment of bowel function

Secondary Outcome Measures

comparison of leakage rate

Full Information

First Posted
June 17, 2008
Last Updated
December 17, 2013
Sponsor
Wakayama Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00701012
Brief Title
Comparison of Low and High Ligation in the Rectal Cancer
Official Title
Comparison of Functional Results of High Ligation and Low Ligation After Anterior Resection for Rectal Cancer - Randomized Controlled Trial-
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wakayama Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
low or high ligation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
low ligation, which the IMA is ligated below the origin of the left colic artery
Arm Title
2
Arm Type
Active Comparator
Arm Description
high ligation, which the IMA is ligated at its origin from the aorta
Intervention Type
Procedure
Intervention Name(s)
preservation of nerve fibers around IMA
Other Intervention Name(s)
low tie
Intervention Description
low ligation
Intervention Type
Procedure
Intervention Name(s)
resection of nerve fibers around IMA
Other Intervention Name(s)
high tie
Intervention Description
high ligation
Primary Outcome Measure Information:
Title
Assessment of bowel function
Time Frame
1 year
Secondary Outcome Measure Information:
Title
comparison of leakage rate
Time Frame
2 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroki Yamaue, MD
Organizational Affiliation
Second Departmant of Surgery, Wakayama Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Wakayama Medical University, Second Department of Surgery
City
Kimiidera
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
17785983
Citation
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.
Results Reference
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PubMed Identifier
11309435
Citation
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.
Results Reference
background
PubMed Identifier
2383724
Citation
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.
Results Reference
background
PubMed Identifier
1643485
Citation
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.
Results Reference
background
PubMed Identifier
15711859
Citation
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.
Results Reference
background
PubMed Identifier
15249246
Citation
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.
Results Reference
background
PubMed Identifier
10690600
Citation
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.
Results Reference
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PubMed Identifier
29071264
Citation
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.
Results Reference
derived
PubMed Identifier
25764287
Citation
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.
Results Reference
derived

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Comparison of Low and High Ligation in the Rectal Cancer

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