Clinical trial NCT00701012: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: low or high ligation
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2008-06-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assessment of bowel function
timeFrame: 1 year
Secondary outcomes:
measure: comparison of leakage rate
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Kimiidera
country: Japan
facility: Wakayama Medical University, Second Department of Surgery
state: Wakayama
Study officials:
affiliation: Second Departmant of Surgery, Wakayama Medical University
name: Hiroki Yamaue, MD
role: STUDY_DIRECTOR
References:
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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.
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.