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

Plain Language Summary

Simplified for easier understanding

This trial compares two surgical techniques for removing right-sided colon cancer: complete mesocolic excision (CME), a more thorough approach that removes the colon along with its surrounding tissue and lymph nodes in one clean piece, versus the standard conventional surgery. Researchers want to know if CME leads to better cancer outcomes. **You may be eligible if...** - You have been diagnosed with right-sided colon cancer (from the cecum to the middle of the transverse colon) - Your cancer stage is T2–T4a (not yet spread to distant organs) - Your overall health is acceptable (anesthesia risk grade I–III) - You have given informed consent **You may NOT be eligible if...** - You are over 85 years old - Your cancer is very early stage (T1, node-negative) or has grown into nearby structures (T4b) - Your BMI is above 30 - You have cancer spread to other organs (metastatic disease) - You have had another cancer in the past 5 years - You need emergency surgery, are pregnant, or take systemic steroids - You have inflammatory bowel disease or familial adenomatous polyposis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Naples, 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

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NCT04871399


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