Comparison of Low and High Ligation in the Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701012
• Other study ID #: WMU512
• Status: Completed
• Phase: N/A
• First received: June 17, 2008
• Last updated: December 17, 2013
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: December 2013
• Source: Wakayama Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• preservation of nerve fibers around IMA
low ligation
• resection of nerve fibers around IMA
high ligation

Locations

Country	Name	City	State
Japan	Wakayama Medical University, Second Department of Surgery	Kimiidera	Wakayama

Sponsors (1)

Lead Sponsor	Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Japan, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2007 Aug 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of bowel function		1 year	Yes
Secondary	comparison of leakage rate		2 weeks	Yes