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

NCT ID: NCT06684223

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3787 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colon Cancer Laparoscopic Colon Surgery Lymph Node Dissection Robotic Surgical Procedures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Anam Hospital

OTHER

Sponsor Role collaborator

Kyungpook National University Chilgok Hospital

OTHER

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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In Ja Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, Songpa, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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mD3 domestic

Identifier Type: -

Identifier Source: org_study_id

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