Colon CancerNCT06684223
Analysis of Surgical and Oncologic Outcomes After Complete Mesocolic Excision or Non-complete Mesocolic Excision for Right-Sided Colon Cancer
An observational study of Colon Cancer and Laparoscopic Colon Surgery, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer, Laparoscopic Colon Surgery, Lymph Node Dissection
- How many people
- 3,787 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2013to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients who underwent laparoscopic or robotic right hemicolectomy from 2013 to 2020
- Patients who received curative right hemicolectomy with lymphadenectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Surgical and Oncologic Outcomes After Compete 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.
Read the detailed description
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
- 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
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival
Recurrence-Free Survival (RFS) between patients who underwent modified D3 and CME procedures from 2013 to 2020.
Measured: Outcome measures will be assessed at 5 years post-surgery.
Secondary outcomes (1)
Comparison of complication rates between modified D3 and complete mesocolic excision
This study will compare the complication rates between modified D3 (mD3) lymphadenectomy and Complete Mesocolic Excision (CME).
Measured: The outcomes will be assessed to determine if any events occurred post-surgery up to October 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jan 2013
- Primary completion31 Dec 2020
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,787 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Anam Hospital, Kyungpook National University Chilgok Hospital, Severance Hospital
- Responsible party
- Principal investigator, In Ja Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684223
- Sponsor's protocol ID
- mD3 domestic
- Status last verified
- Nov 2024
- First submitted
- 10 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Surgical and Oncologic Outcomes After Compete Mesocolic Excision or Non-complete Mesocolic Excision for Right-Sided Colon Cancer
- ClinicalTrials.gov ID
- NCT06684223
- Acronym / sponsor ID
- mD3 domestic
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,787 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korea University Anam Hospital, Kyungpook National University Chilgok Hospital, Severance Hospital
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients who underwent laparoscopic or robotic right hemicolectomy from 2013 to 2020
- Patients who received curative right hemicolectomy with lymphadenectomy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Laparoscopic Colon Surgery, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival (time frame: Outcome measures will be assessed at 5 years post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.