Skip to main content
OpenTrials
Completed

NCT Number: NCT06865586

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

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

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.