A Comparative Study of Tumor Specific Mesocolic Excision and Complete Mesocolic Excision for Right Sided Colon Cancer : Asian Multicenter Retrospective Study

March 6, 2025 updated by: In Ja Park, Asan Medical Center

The goal of this observational study is to determine the optimal surgical strategy based on oncologic outcomes in patients with stage I-III right-sided colon cancer who underwent curative right hemicolectomy.

The main question it aims to answer is: Is there a significant difference in 5-year recurrence-free survival (RFS) between patients treated with Complete Mesocolic Excision (CME) and those treated with tumor specific mesocolic excision (TSME)? Participants will include patients who underwent curative right hemicolectomy for right-sided colon cancer between 2015 and 2020 at eight institutions. They will be categorized into two groups based on the surgical technique received-CME group and TSME group-and evaluated for primary and secondary endpoints of 5-year recurrence-free survival (RFS) and overall survival (OS), respectively.

Study Overview

Status

Completed

Conditions

Detailed Description

This observational, population-based cohort study was conducted following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines, with approval obtained from the institutional review board (IRB) of the primary institution and the ethics committees of each participating institution in the Republic of Korea, Hong Kong, and Taiwan. Given that the study utilized anonymized retrospective data, the requirement for informed consent was waived.

The study aimed to evaluate the efficacy and safety of Tumor Specific Mesocolic Excision (TSME) compared to Complete Mesocolic Excision (CME) in patients with right-sided colon cancer. Patients diagnosed with right-sided colon cancer who underwent laparoscopic or robotic right hemicolectomy between 2015 and 2020 were included. Surgical techniques were classified into modified TSME or CME, and the study assessed oncologic outcomes, including recurrence-free survival (RFS), overall survival (OS), lymph node yield, and stage distribution.

Data collection was conducted at multiple medical centers across Asia to ensure a diverse representation of patient demographics and clinical practices. The participating institutions included Asan Medical Center, Korea University Anam Hospital, Severance Hospital, Kyungpook National University Chilgok Hospital, Chinese University of Hong Kong, North District Hospital, Pamela Youde Nethersole Eastern Hospital, and China Medical University Hospital. These centers, varying in location and size, enhance the study's generalizability within the context of right-sided colon cancer management in Asia.

Study Type

Observational

Enrollment (Actual)

3326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study included patients who underwent laparoscopic or robotic right hemicolectomy from 2015 to 2020 at 8 instituions : Asan Medical Center, Korea University Anam Hospital, Severance Hospital, Kyungpook National University Chilgok Hospital, Chinese University of Hong Kong, North District Hospital, Pamela Youde Nethersole Eastern Hospital, and China Medical University Hospital.

Description

Inclusion Criteria:

  • Patients who underwent laparoscopic or robotic right hemicolectomy from 2015 to 2020
  • Patients who received curative right hemicolectomy with lymphadenectomy

Exclusion Criteria:

  • Familial adenomatous polyposis (FAP)
  • Hereditary non-polyposis colon cancer (HNPCC)
  • Patients with inflammatory bowel disease
  • Patients with synchronous malignancies in other organs
  • Patients with non-adenocarcinoma histology of colon cancer
  • Patients with follow-up duration of less than 3 months

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

Cohorts and Interventions

Group / Cohort
Patients who underwent laparoscopic or robotic right hemicolectomy with CME from 2015 to 2020
Patients who underwent laparoscopic or robotic right hemicolectomy with Complete mesocolic excision from 2015 to 2020 in 8 centers
Patients who underwent with tumor specific mesocolic exicision from 2015 to 2020
Patients who underwent laparoscopic or robotic right hemicolectomy with tumor specific mesocolic exicision from 2015 to 2020 in 8 centers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5 year Recurrence free survival
Time Frame: Outcome measures will be assessed at 5 years post-surgery.
Recurrence-Free Survival (RFS) between patients who underwent TSME and CME procedures from 2015 to 2020
Outcome measures will be assessed at 5 years post-surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Outcome measures will be assessed at 5 years post-surgery.
Overall survival (OS) between patients who underwent TSME and CME procedures form 2015 to 2020
Outcome measures will be assessed at 5 years post-surgery.

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Collaborators

Chinese University of Hong Kong
China Medical University Hospital
Korea University Anam Hospital
Kyungpook National University Chilgok Hospital
Severance Hospital
North District Hospital
Pamela Youde Nethersole Eastern Hospital

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)

January 1, 2015

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

January 15, 2025

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART core

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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