NCT01861678

Brief Summary

The tying at a radix of the inferior mesenteric artery (IMA) is recognized as radical cure technique in a rectal cancer surgery in Japan. In one side, the preserving the left colic artery (LCA) that is the technique to maintain blood flow of proximal sigmoid colon is performed in practice. However, there is no evidence that shows effectiveness of this technique. We conducted a randomized trial that compared between high tie and low tie of the IMA in rectal anterior resection to define an appropriate portion of IMA tying.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
331

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 6, 2013

Status Verified

August 1, 2013

Enrollment Period

6.2 years

First QC Date

May 21, 2013

Last Update Submit

August 4, 2013

Conditions

Rectal CancerColon Rectal Resection

Keywords

Rectal cancerAnterior resectionHigh tie of inferior mesenteric arteryLow tie of inferior mesenteric arteryRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Anastomotic leakage rate

    Anastomotic leakage rate is defined as an incontinuity at the anastomosis using circular stapler.

    14 days after surgery

Secondary Outcomes (3)

  • Overall survival

    5 years

  • Operation time

    1 day after surgery

  • Amount of blood loss

    1 day after surgery

Study Arms (2)

High tie of IMA

ACTIVE COMPARATOR

In High tie group, IMA was transected at its origin from the abdominal aorta.

Procedure: High tie of IMA

Low tie of IMA

EXPERIMENTAL

In the low tie of the IMA, IMA was separated after branching to the left colic artery. The lymph node dissection around the IMA at its origin was performed.

Procedure: Low tie of IMA

Interventions

High tie of IMAPROCEDURE

Conventional technique

Also known as: High tie
High tie of IMA
Low tie of IMAPROCEDURE

Technique for preserving left colic arterial perfusion

Also known as: Low tie
Low tie of IMA

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 20 years old or over
  • Anterior resection is scheduled for rectal cancer and rectosigmoid cancer preoperatively.
  • Histologically proven adenocarcinoma
  • Clinical tumor penetrates visceral peritoneum (T4a), no metastasis (M0) or lower T factor
  • Elective operation
  • Tolerable surgery under general anesthesia
  • No history of laparotomy for colorectal resection except appendectomy
  • Provided written informed consent

You may not qualify if:

  • Synchronous or metachronous (within 5 years) malignancy in another organ except carcinoma in situ
  • Multiple colorectal cancer that needs reconstruction two or more times
  • Acute intestinal obstruction or perforation due to rectal cancer
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

Location

Related Publications (1)

  • Fujii S, Ishibe A, Ota M, Watanabe K, Watanabe J, Kunisaki C, Endo I. Randomized clinical trial of high versus low inferior mesenteric artery ligation during anterior resection for rectal cancer. BJS Open. 2018 Jun 8;2(4):195-202. doi: 10.1002/bjs5.71. eCollection 2018 Aug.

    PMID: 30079388DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Chikara Kunisaki, Professor

    Yokohama City University, Gastroenterological Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 23, 2013

Study Start

July 1, 2006

Primary Completion

September 1, 2012

Study Completion

September 1, 2017

Last Updated

August 6, 2013

Record last verified: 2013-08

Locations

JP(1)