NCT06865586

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

6 years

First QC Date

March 6, 2025

Last Update Submit

March 6, 2025

Conditions

Keywords

colon cancerright hemicolectomycomplete mesocolic excisionlymph node dissectionmicroinvasive surgery

Outcome Measures

Primary Outcomes (1)

  • 5 year Recurrence free survival

    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 Outcomes (1)

  • Overall survival

    Outcome measures will be assessed at 5 years post-surgery.

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa, 05505, South Korea

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 10, 2025

Study Start

January 1, 2015

Primary Completion

December 31, 2020

Study Completion

January 15, 2025

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations