Comparison of Low and High Ligation in the Rectal Cancer

NCT00701012 | Completed DMC

• 1 other identifier: WMU512
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

low or high ligation

Outcome Measures

Primary Outcomes (1)

• Assessment of bowel function

  1 year

Secondary Outcomes (1)

• comparison of leakage rate

  2 weeks

Study Arms (2)

1

EXPERIMENTAL

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

Procedure: preservation of nerve fibers around IMA

2

ACTIVE COMPARATOR

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

Procedure: resection of nerve fibers around IMA

Interventions

preservation of nerve fibers around IMA PROCEDURE

low ligation

Also known as: low tie

1

resection of nerve fibers around IMA PROCEDURE

high ligation

Also known as: high tie

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• On the basis of whether anterior resection was anticipated at WMUH for rectosigmoid and rectal cancer, and appropriate informed consent was obtained.

You may not qualify if:

• Patients who could not respond to medical interview for own bowel function
• Patients without an informed consent

Sponsors & Collaborators

• Wakayama Medical University: lead

Study Sites (1)

Wakayama Medical University, Second Department of Surgery

Kimiidera, Wakayama, 641-8510, Japan

Location

Related Publications (9)

• 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.

  PMID: 17785983 BACKGROUND

• 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.

  PMID: 11309435 BACKGROUND

• 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.

  PMID: 2383724 BACKGROUND

• 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.

  PMID: 1643485 BACKGROUND

• 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.

  PMID: 15711859 BACKGROUND

• 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.

  PMID: 15249246 BACKGROUND

• 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.

  PMID: 10690600 BACKGROUND

• 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.

  PMID: 29071264 DERIVED

• 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.

  PMID: 25764287 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Hiroki Yamaue, MD

  Second Departmant of Surgery, Wakayama Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Second Department of Surgery

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2008
• Study Completion: December 1, 2011
• Last Updated: December 18, 2013

Record last verified: 2013-12

Locations

JP (1)