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

NCT04871399 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2020-07-13
Last updated
2022-11-14

Condition(s) studied

Colon Cancer

Investigational drug(s) / intervention(s)

Conventional Right hemicolectomy (Non-CME)Right hemicolectomy with CME+CVL

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.

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

  • Disease-free survival at 3 years — 3 Years.
    The length of time after surgery without any signs or symptoms of local or distant recurrence.

Trial sites (14)

FacilityCityRegionStatus
Ospedale della Misericordia Grosseto Arezzo Not Yet Recruiting
Ospedale Città di Sesto San Giovanni Sesto San Giovanni Milano Not Yet Recruiting
S. Andrea Hospital La Spezia Spezia Not Yet Recruiting
Candiolo Cancer Institute - IRCCS Candiolo Torino Not Yet Recruiting
Ospedale E. Agnelli Pinerolo Pinerolo Torino Not Yet Recruiting
Maggiore Bellaria Hospital, Bologna Bologna Italy Not Yet Recruiting
Università degli Studi di Ferrara Ferrara Italy Not Yet Recruiting
Ospedale Policlinico San Martino Genova Italy Not Yet Recruiting
Azienda Ospedaliera Universitaria Policlinico "G. Martino" Messina Italy Not Yet Recruiting
European Institute of Oncology Milan Italy Not Yet Recruiting
Federico II University Naples Italy Not Yet Recruiting
University of Rome Tor Vergata Rome Italy Not Yet Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy Not Yet Recruiting
University of Turin (AOU.San Luigi Gonzaga) Torino Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04871399 on ClinicalTrials.gov ↗ ← All trials in Italy