Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer

NCT04871399 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2022-11-14

No results posted yet for this study

Summary

An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.

Conditions

Interventions

PROCEDURE

Conventional Right hemicolectomy (Non-CME)

Transecting the Ileocolic Vein and Artery close to the Superior Mesenteric Vessels without clearing the superior mesenteric vein (SMV) from the adipose tissue. Transecting the Right Colic Vein and Artery and superior right colic vein (when present) peripherally. Transecting the Right branches of the Middle Colic Vein (MCV) and the Middle Colic Artery (MCA) peripherally, without clearing the main trunk of the MCV and the MCA. The Right Gastroepiploic Vein and artery are never transacted.

PROCEDURE

Right hemicolectomy with CME+CVL

Separation of the visceral fascia from the parietal fascia by sharp dissection leaving intact mesocolon coverage. Transecting the supplying vessels at their origin from the main vessels, particularly: * The Ileocolic Vessels, The Right Colic Vessels,The superior right colic vein (when present), The Right branches of the Middle Colic Vein and of the Middle Colic Artery * The MCV and MCA at their origin in case of cancer of the hepatic flexure or of the proximal third of the transverse colon, as well as The Right Gastroepiploic Vessels at their origin from the gastrocolic trunk of Henle (GCTH) and the gastroduodenal artery. The SMV should be cleared from all adipose tissue all along its anterior surface until its intrapancreatic entrance.

Sponsors & Collaborators

  • Federico II University

    collaborator OTHER
  • Agnelli Hospital, Italy

    collaborator OTHER
  • Ospedale della Misericordia

    collaborator OTHER
  • Candiolo Cancer Institute - IRCCS

    collaborator OTHER
  • Maggiore Bellaria Hospital, Bologna

    collaborator OTHER
  • Università degli Studi di Ferrara

    collaborator OTHER
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    collaborator OTHER
  • Azienda Ospedaliera Universitaria Policlinico "G. Martino"

    collaborator OTHER
  • Ospedale Policlinico San Martino

    collaborator OTHER
  • University of Rome Tor Vergata

    collaborator OTHER
  • S. Andrea Hospital

    collaborator OTHER
  • European Institute of Oncology

    collaborator OTHER
  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Maurizio Degiuli, Professor · University of Turin, Department of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04871399 on ClinicalTrials.gov