Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer (CoME-In)

November 11, 2022 updated by: University of Turin, Italy

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to compare the Complete Mesocolic Excision With Central Vascular Ligation (CME+CVL) with the standard (non-CME) right hemicolectomy in patients with right or proximal transverse colon cancer stage II-IV(AJCC 8th edition) to determine the short and long term outcomes in terms of disease-free survival (DFS) as a primary endpoint, and safety, oncologic outcomes, quality of surgery and quality of life (QoL) as secondary endpoints.

Eligible patients will be randomized with a 1:1 ratio between CME + CVL vs standard non-CME right colectomy. The randomization sequence will be generated centrally by a computed algorithm and kept concealed to investigators.

The Right colectomy with CME + CVL includes the removal of the accessory lymphovascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. Despite the surgical approach and the type of procedure adopted, the operation should be strictly conducted following the general rules for colorectal oncologic resection, particularly as concerns proximal and distal margins length and lymph node retrieval.

All surgical approaches (open, laparoscopic, or robotic) will be allowed while the type of anastomosis performed and drain placement will be up to the surgeon's discretion.

Demographic, baseline, perioperative and postoperative characteristics will be analyzed as well.

The study expected to last six and a half years, of which one and a half years for recruiting 416 patients, 208 each arm, with five years of follow-up. Patients will be followed up at 1, 4, 12, 24, 36, and 60 months postoperatively.

Study Type

Interventional

Enrollment (Anticipated)

416

Phase

  • Not Applicable

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

  • Italy
      • Bologna, Italy, 40124
      • Ferrara, Italy, 44121
        • Not yet recruiting
        • Università degli Studi di Ferrara
        • Contact:
      • Genova, Italy, 16132
        • Not yet recruiting
        • Ospedale Policlinico San Martino
      • Messina, Italy, 98124
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Policlinico "G. Martino"
        • Contact:
      • Milano, Italy, 20141
      • Napoli, Italy, 80138
      • Rome, Italy, 00168
      • Rome, Italy, 00133
        • Not yet recruiting
        • University of Rome Tor Vergata
      • Torino, Italy, 10043
    • Arezzo
      • Grosseto, Arezzo, Italy, 52100
        • Not yet recruiting
        • Ospedale Della Misericordia
        • Contact:
    • Milano
      • Sesto San Giovanni, Milano, Italy, 20099
    • Spezia
    • Torino
      • Candiolo, Torino, Italy, 10060
      • Pinerolo, Torino, Italy, 10064
        • Not yet recruiting
        • Ospedale E. Agnelli Pinerolo

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

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Conventional Right hemicolectomy (Non-CME)
Patients will undergo conventional non-CME procedure.
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.
EXPERIMENTAL: Right hemicolectomy with CME+CVL
Patients will undergo Right hemicolectomy CME+CVL procedure.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival at 3 years
Time Frame: 3 Years.
The length of time after surgery without any signs or symptoms of local or distant recurrence.
3 Years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety-Operative time.
Time Frame: Intraoperative
Total time from incision to skin closure expressed in minutes.
Intraoperative
Safety-Intraoperative blood loss.
Time Frame: Intraoperative
Defined by the volume drained in cm2 into aspiration systems and weight of gauzes, calculated, subtracting the weight of the dry gauzes and volume of saline solution used for irrigation.
Intraoperative
Safety-Intraoperative blood transfusion.
Time Frame: Intraoperative
Defined as the number of red blood cells, platelets, or plasma units transfused during the intraoperative time.
Intraoperative
Safety- Intraoperative Complications.
Time Frame: Intraoperative
Defined as any deviation from the ideal intraoperative course occurring during the operative time, Using the Classification of Intraoperative Complications(CLASSIC).
Intraoperative
Early postoperative complications.
Time Frame: 30 postoperative days.
Number of patients with any deviation from the normal postoperative course grading by The Clavien-Dindo classification.
30 postoperative days.
Late postoperative complications.
Time Frame: From the 31st postoperative days to the end of the study.
The number of patients with any deviation from the normal postoperative course grading by The Clavien-Dindo classification.
From the 31st postoperative days to the end of the study.
Safety- Length of stay.
Time Frame: 30 Days.
Defined as the length of an inpatient episode of care, calculated from the day of operation to the first discharge and based on the number of nights spent in the hospital.
30 Days.
Safety- Postoperative mortality rate.
Time Frame: 30 Days.
The all-cause death rate, within 30 days after surgery in or out of the hospital.
30 Days.
Overall Survival at 3 years
Time Frame: 3 Years.
Defined as the time from random assignment to the date of death due to any cause.
3 Years.
Overall Survival at 5 years.
Time Frame: 5 Years.
Defined as the time from random assignment to the date of death due to any cause.
5 Years.
Disease-free survival.
Time Frame: 5 Years.
Defined as the length of time after Surgical treatment (CME+CVL or Conventional non-CME procedure) that the patient survives without any signs or symptoms of colon cancer.
5 Years.
Other Oncologic outcomes.
Time Frame: 30 Days.
The number of positive, negative, and total lymph nodes harvested, Quality of surgery specimen, quality of life by EORTC specific Questionnaires
30 Days.

Collaborators and Investigators

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

Sponsor

University of Turin, Italy

Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Federico II University
Università degli Studi di Ferrara
University of Rome Tor Vergata
European Institute of Oncology
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Candiolo Cancer Institute - IRCCS
Ospedale Policlinico San Martino
Maggiore Bellaria Hospital, Bologna
S. Andrea Hospital
Ospedale della Misericordia
Agnelli Hospital, Italy

Investigators

  • Principal Investigator: Maurizio Degiuli, Professor, University of Turin, Department of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 13, 2020

Primary Completion (ANTICIPATED)

January 1, 2027

Study Completion (ANTICIPATED)

January 1, 2027

Study Registration Dates

First Submitted

April 23, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (ACTUAL)

May 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N.110/2019/U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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