Analysis of Surgical and Oncologic Outcomes After Complete Mesocolic Excision or Non-complete Mesocolic Excision for Right-Sided Colon Cancer

NCT06684223 | Completed

• 1 other identifier: mD3 domestic
• Study Type: observational
• Target: 3,787
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to investigate the efficacy and safety of a modified D3 lymphadenectomy approach compared to Complete Mesocolic Excision (CME) in patients with right-sided colon cancer. The main question it aims to answer is: Does a modified D3 approach improve disease-free survival (DFS) in patients with Stage I-III right-sided colon cancer who undergo right-sided colectomy, without increasing surgical complications compared to CME? Patients with right-sided colon cancer, Stage I-III, who undergo either modified D3 lymphadenectomy or CME as part of their standard treatment, will have their DFS, complications, bleeding volume, number of lymph nodes harvested, and stage distribution compared over a follow-up period. This study ultimately aims to determine the optimal surgical approach for maximizing oncologic outcomes in right-sided colon cancer.

Conditions

Colon Cancer; Laparoscopic Colon Surgery; Lymph Node Dissection; Robotic Surgical Procedures

Keywords

colon cancer; right hemicolectomy; laparoscopic colectomy; complete mesocolic excision; lymph node dissection; robotic colectomy

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival

  Recurrence-Free Survival (RFS) between patients who underwent modified D3 and CME procedures from 2013 to 2020.

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

Secondary Outcomes (1)

• Comparison of complication rates between modified D3 and complete mesocolic excision

  The outcomes will be assessed to determine if any events occurred post-surgery up to October 2024

Study Arms (2)

Patients who underwent laparoscopic or robotic right hemicolectomy with modifiedD3 from 2013 to 2020

Patients who underwent laparoscopic or robotic right hemicolectomy with modified D3 lymphadenectomy from 2013 to 2020 in 4 centers

Patients who underwent laparoscopic or robotic right hemicolectomy with CME from 2013 to 2020

Patients who underwent laparoscopic or robotic right hemicolectomy with Complete mesocolic excision from 2013 to 2020 in 4 centers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included patients who underwent laparoscopic or robotic right hemicolectomy from 2013 to 2020 at four institutions: Asan Medical Center, Kyungpook National University Chilgok Hospital, Korea University Anam Hospital, and Yonsei University Severance Hospital.

You may qualify if:

• Patients who underwent laparoscopic or robotic right hemicolectomy from 2013 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Korea University Anam Hospital: collaborator
• Kyungpook National University Chilgok Hospital: collaborator
• Severance Hospital: collaborator

Study Sites (1)

Asan Medical Center

Seoul, Songpa, 05505, South Korea

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal 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: November 10, 2024
• First Posted: November 12, 2024
• Study Start: January 1, 2013
• Primary Completion: December 31, 2020
• Study Completion: October 31, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)