Colonic NeoplasmsMORDIGONCT06371898
Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter Study (MORDIGO)
An observational study of Colonic Neoplasms, run by University Hospital, Brest at 1 site in France.
Trial summary
Propose a one-piece endoscopic resection such as endoscopic submucosal dissection (ESD) rather than surgery for benign lesions and superficial T1 cancers colorectal cancers offers comparable efficacy with better tolerability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2024to 17 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with colonic neoplasms
Who may be able to join
- Group A :
- Patients from the FECCO cohort
- who have undergone ESDresection of a giant lesion, defined by a fresh specimen measuring more than 8cm long axis, of the colon
- Between September 2019 and 2022
- Major
- Patient affiliated to a social security scheme
Show all 12Show fewer
- Group B:
- Patients from the Registre des Tumeurs Digestives Registry (Brest University Hospital)
- Having undergone colectomy with lymph node dissection for intramucosal colonic adenocarcinoma, T1 or T2 colonic adenocarcinoma
- Between September 2019 and 2022
- Adults
- patient affiliated to a social security scheme
Who cannot join
- - rectal lesion ;
- patients under legal protection (guardianship, curatorship,
- ...) or deprived of liberty ;
- refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter Study
Propose a one-piece endoscopic resection such as endoscopic submucosal dissection (ESD) rather than surgery for benign lesions and superficial T1 cancers colorectal cancers offers comparable efficacy with better tolerability. This approach is all the more in the rectum, even for giant lesions lesions (over 8cm), as rectal surgery is particularly morbid, with particularly morbid, with a functional impact that can impact, whereas rectal ESD is less prone to complications fewer complications than in the colon. Colonic ESD for giant lesions is a longer and more morbid more time-consuming and morbid than for smaller lesions, the question of colonic surgery in this indication. this indication. In order to compare the morbidity data of patients of giant lesions with those of colectomy, a control group colectomy, a surgical control group will be set up, including patients including patients having undergone surgery for in situ T1 or T2 in situ colon cancer. Surgical resections of resection of benign lesions is generally not indicated not indicated and would not provide the necessary necessary for a comparison. T3 and T4 lesions with their own their own morbidity will be excluded.
- Conditions
- Colonic Neoplasms
- Keywords
- endoscopy submucosal dissection, colonic neoplasms, colonic surgery
- 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 |
|---|---|---|
| ESD | Cohort of patients with giant colonic lesions resected by ESD, in which patients will be matched to group B | |
| surgery | Cohort of patients who underwent colonic surgery for T1 or T2 or in situ colon cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 days severe morbidity
Comparison of severe morbidity (Clavien dindo ≥ IIIb) at 30 days of patients who underwent DSM for giant colonic lesion (group A) to that of patients who underwent surgery surgery equivalent to that which would be performed for such a lesion (group B)
Measured: 30 days
Secondary outcomes (8)
morbidity of ESD group
Measured: 30 days
comparison of morbidity in both groups
Measured: 30 days
reintervention
Measured: 30 days
stomia
Measured: 30 days
length of hospital stay
Measured: 30 days
readmission
Measured: 30 days
mortality
Measured: 30 days
risk factors for morbidity
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start18 Mar 2024
- Primary completion17 Jun 2025 (estimated)
- Study completion17 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371898
- Sponsor's protocol ID
- 29BRC24.0088 - MORDIGO
- Acronym
- MORDIGO
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter Study
- ClinicalTrials.gov ID
- NCT06371898
- Acronym / sponsor ID
- MORDIGO / 29BRC24.0088 - MORDIGO
- Conditions
- Colonic Neoplasms
- Keywords
- endoscopy submucosal dissection, colonic neoplasms, colonic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 17 Jun 2025 (estimated)
- Study completion
- 17 Jun 2025 (estimated)
- First posted
- 17 Apr 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.
Propose a one-piece endoscopic resection such as endoscopic submucosal dissection (ESD) rather than surgery for benign lesions and superficial T1 cancers colorectal cancers offers comparable efficacy with better tolerability. This approach is all the more in the rectum, even for giant lesions lesions (over 8cm), as rectal surgery is particularly morbid, with particularly morbid, with a functional impact that can impact, whereas rectal ESD is less prone to complications fewer complications than in the colon. Colonic ESD for giant lesions is a longer and more morbid more time-consuming and morbid than for smaller lesions, the question of colonic surgery in this indication. this indication. In order to compare the morbidity data of patients of giant lesions with those of colectomy, a control group colectomy, a surgical control group will be set up, including patients including patients having undergone surgery for in situ T1 or T2 in situ colon cancer. Surgical resections of resection of benign lesions is generally not indicated not indicated and would not provide the necessary necessary for a comparison. T3 and T4 lesions with their own their own morbidity will be excluded.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESD | – | –Cohort of patients with giant colonic lesions resected by ESD, in which patients will be matched to group B |
| surgery | – | –Cohort of patients who underwent colonic surgery for T1 or T2 or in situ colon cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with colonic neoplasms
Key inclusion criteria (12 listed)
- Group A :
- Patients from the FECCO cohort
- who have undergone ESDresection of a giant lesion, defined by a fresh specimen measuring more than 8cm long axis, of the colon
- Between September 2019 and 2022
- Major
Key exclusion criteria (4 listed)
- - rectal lesion ;
- patients under legal protection (guardianship, curatorship,
- ...) or deprived of liberty ;
- refusal to participate.
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
30 days severe morbidity
Time frame: 30 days
Comparison of severe morbidity (Clavien dindo ≥ IIIb) at 30 days of patients who underwent DSM for giant colonic lesion (group A) to that of patients who underwent surgery surgery equivalent to that which would be performed for such a lesion (group B)
8 secondary outcomes
morbidity of ESD group
Time frame: 30 days
comparison of morbidity in both groups
Time frame: 30 days
reintervention
Time frame: 30 days
stomia
Time frame: 30 days
length of hospital stay
Time frame: 30 days
readmission
Time frame: 30 days
mortality
Time frame: 30 days
risk factors for morbidity
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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 Colonic Neoplasms, run by University Hospital, Brest at 1 site in France.
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 12 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Apr 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 France. 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?
Results are not available in the source record.
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?
30 days severe morbidity (time frame: 30 days). 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 17 Apr 2024.