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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Laparoscopic Colon Surgery Lymph Node Dissection Neoplasms Neoplasms by Site Robotic Surgical Procedures

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, Songpa, 05505, South Korea

About this study

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

The study aimed to evaluate the efficacy and safety of modified D3 lymphadenectomy compared to Complete Mesocolic Excision (CME) in patients with right-sided colon cancer. Patients with right-sided colon cancer who underwent laparoscopic or robotic right hemicolectomy from 2013 to 2020 were included. Patients were classified into those who received modified D3 lymphadenectomy or CME, and the study assessed disease-free survival (DFS), surgical complications, bleeding volume, lymph node yield, and stage distribution.

Data collection was carried out at multiple tertiary medical centers across the Republic of Korea, ensuring a broad representation of patient demographics and clinical practices. The participating institutions included Asan Medical Center, Korea University Anam Hospital, Severance Hospital, and Kyungpook National University Chilgok Hospital. These centers vary in location and size, enhancing the study's generalizability within the context of right-sided colon cancer management in Korea.

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 2013 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

Treatment and study plan

Primary outcomes

Recurrence free survival

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

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

Secondary outcomes

Comparison of complication rates between modified D3 and complete mesocolic excision

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

This study will compare the complication rates between modified D3 (mD3) lymphadenectomy and Complete Mesocolic Excision (CME).

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

Korea University Anam Hospital
Kyungpook National University Chilgok Hospital
Severance Hospital

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2020
Study completion: 2024
First posted: Nov 12, 2024
Registry last updated: Nov 20, 2024

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.

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