RecruitingNot ApplicableNCT04871399

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

Complete Mesocolic Excision With Central Vascular Ligation in Comparison With Conventional Surgery for the Right Colon Cancer: An Italian Randomized Trial


Sponsor

University of Turin, Italy

Enrollment

416 participants

Start Date

Jul 13, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria3

  • American Society of Anesthesiologists(ASA) grade I-III.
  • Right colon cancer (\*The right-sided location of the cancer is defined as the location from the caecum up to the proximal third of the transverse colon), preoperative assessment of tumor stage T2-T4a, any N or T any N+ according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015); no distant metastasis.
  • Informed consent

Exclusion Criteria12

  • Age \> 85 years old.
  • T1, N0
  • T4b, any N
  • BMI \> 30.
  • Metastatic disease (Abdominal and chest CT scan will be mandatory to exclude distant metastasis.)
  • American Society of Anesthesiologists(ASA) grade IV.
  • History of cancer in recent 5 years.
  • Need for Emergency surgery.
  • Infectious disease requiring treatment.
  • Pregnancy.
  • Use of systemic steroids.
  • No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Interventions

PROCEDUREConventional 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.

PROCEDURERight 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.


Locations(14)

Ospedale della Misericordia

Grosseto, Arezzo, Italy

Ospedale Città di Sesto San Giovanni

Sesto San Giovanni, Milano, Italy

S. Andrea Hospital

La Spezia, Spezia, Italy

Candiolo Cancer Institute - IRCCS

Candiolo, Torino, Italy

Ospedale E. Agnelli Pinerolo

Pinerolo, Torino, Italy

Maggiore Bellaria Hospital, Bologna

Bologna, Italy

Università degli Studi di Ferrara

Ferrara, Italy

Ospedale Policlinico San Martino

Genova, Italy

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Messina, Italy

European Institute of Oncology

Milan, Italy

Federico II University

Napoli, Italy

University of Rome Tor Vergata

Rome, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

University of Turin (AOU.San Luigi Gonzaga)

Torino, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04871399


Related Trials