Anatomical Classifications of Henle's Trunk (HeLaRC)

December 6, 2017 updated by: Shanghai Minimally Invasive Surgery Center

Multicenter Clinical Trial of Anatomical Classifications of Henle's Trunk in Laparoscopic Right Hemi-colectomy.

Right colon has complicated anatomy which is surrounded by important organs. The variations of vessels are more frequent than in left colon, which contribute to the difficulty of surgery. Among the variations, Henle's trunk is more obvious that makes it the commonest cause of bleeding during operation. Several veins can be found to conjoin the Henle's trunk, among which ASPDV and REGV are the two common tributaries while RCV,MCV,SRCV may vary from people to people. As a result, a better understanding of the anatomical classification of Henle's trunk is a must during operation. However, existing studies of Henle's trunk are very rare and often single-centered with minimal samples.In order to achieve better surgical outcome and reduce operative complications, the investigators design this study to investigate the anatomical classification of Henle's trunk and the surgical outcome of each type.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sahgnhai
      • Shanghai, Sahgnhai, China, 200000
        • Recruiting
        • Shanghai Ruijin Hospttal
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study is a prospective study，and based on the number of branches, the anticipant populations of this study is 500.

Description

Inclusion Criteria:

  1. Patients who undergoing laparoscopic right hemi-colectomy with D3 lymphadenectomy
  2. Pathology: adenocarcinoma or high-grade intraepithelial neoplasia proven by colonoscopic biopsy.
  3. Localization: tumor located between cecum and proximal 1/3 portion of transverse colon.
  4. Patients have to be aware of the aim of the trial, and have signed the informed consent.

Exclusion Criteria:

  1. History of any gastrointestinal surgery.
  2. Patients with ileus, perforation, bleeding and any other conditions required of emergent surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
classifications of Henle's trunk
Time Frame: 2 yeas
based on the number of colic veins that conjoin the SMV
2 yeas

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Minimally Invasive Surgery Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2017

Primary Completion (Anticipated)

May 17, 2019

Study Completion (Anticipated)

May 17, 2020

Study Registration Dates

First Submitted

December 1, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (Actual)

December 7, 2017

Study Record Updates

Last Update Posted (Actual)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • ShanghaiMISC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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