Crohn Disease3T-LAPNCT04192825
Analysis of Therapeutic Management Strategies for Anal Suppurations of Crohn's Disease
An observational study of Crohn Disease and Anal Suppurations, run by Rennes University Hospital at 1 site in France.
Trial summary
Determine the optimal therapeutic combination associated with complete clinical and anatomical remission of anal suppurations of Crohn's disease at 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Anal Suppurations, Drainage Procedure
- What is being tested?
- surgical treatment
- Type of treatment
- Surgery or procedure
- How many people
- 440 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2020to 3 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Person suffering from anal suppuration related to Crohn's Disease
Who may be able to join
- Persons over 18 years of age
- People suffering from anal suppuration of Crohn's disease for whom a drainage procedure is planned.
- Person who has received written and oral information about the protocol and has not expressed opposition to participate in the study.
Who cannot join
- No one who is unable to have an anesthetic, structural or psychological examination by MRI and/or surgery.
- Person planning a planned absence that could hinder participation in the research (travel abroad, relocation, impending transfer);
- Person with an associated pathology that is a priority for care;
- Vulnerable person (minors, persons under guardianship or curatorship, or deprived of their liberty by a judicial or administrative decision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Rennes
Rennes, 35000
Céline Gautier, 2992843 21 ext. +33
Laurent Siproudhis, PH-PD
About this study
Determine the optimal therapeutic combination associated with complete clinical and anatomical remission of anal suppurations of Crohn's disease at 12 months.
Read the detailed description
The management of anoperineal suppurations of Crohn's disease is most often based on clinical practice recommendations, the results of randomized controlled trials and also the analysis of monocentric cohort studies from expert centres. In these latter studies, there is an overall improvement in patients during follow-up with a high level of satisfaction (two thirds of cases), often assessed by the operator himself or the clinician who provides therapeutic management. The most striking finding is the one that highlights the use of combined therapeutic strategies combining immunosuppressants, biotherapies, antibiotics, surgical drainage and surgical reconstruction procedures to varying degrees. Thus, the absence of fistula pathway flow in the long term is the consequence of both maintenance treatment with biotherapies and several surgical procedures. When the characteristics of fistula pathways considered healed on clinical examination are analysed by MRI exploration, an active unhealed pathway persists in two thirds of cases, again emphasizing the inadequacy of clinical examination as a means of assessing recovery. For this reason, fistula pathway closure strategies do not provide much greater benefit than simple removal of the drainage loop. Conversely, medical treatment optimization strategies based on MRI evaluation of the therapeutic response have demonstrated high efficacy. It is necessary to (re)define the therapeutic management of patients with anoperineal lesions. This strategy must be based on a better initial stratification of patients based on prognostic factors derived from available scientific data. A second step consists in setting therapeutic efficacy objectives that take into account the control of the inflammatory component of anal Crohn's disease and the preservation of the anatomical and functional capital of the anus. Only a large prospective cohort at the national level provides the opportunity to study these prognostic factors and to specify the level of optimal therapeutic responses
- Conditions
- Crohn Disease, Anal Suppurations, Drainage Procedure
- Being tested
- surgical treatment
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical treatmentProcedure or surgery
surgical drainage and/or surgical reconstruction procedures to anoperineal suppurations according to the doctor's decision
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and anatomical healing
The healing of anal fistula is defined by the combination of two criteria at 12 months :
- MRI criteria = absence of a T2 hyper signal from the path(s) AND the absence of an abscess AND
- Complete clinical response = no pain, no discharge, and no drain
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start3 Feb 2020
- Primary completion3 Aug 2025 (estimated)
- Study completion3 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Prospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent SIPROUDHIS, PH-PD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192825
- Sponsor's protocol ID
- 35RC18_8808_3T-LAP
- Acronym
- 3T-LAP
- Status last verified
- Apr 2023
- First submitted
- 5 Dec 2019
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Therapeutic Management Strategies for Anal Suppurations of Crohn's Disease
- ClinicalTrials.gov ID
- NCT04192825
- Acronym / sponsor ID
- 3T-LAP / 35RC18_8808_3T-LAP
- Conditions
- Crohn Disease, Anal Suppurations, Drainage Procedure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 3 Aug 2025 (estimated)
- Study completion
- 3 Aug 2028 (estimated)
- First posted
- 10 Dec 2019 (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.
Determine the optimal therapeutic combination associated with complete clinical and anatomical remission of anal suppurations of Crohn's disease at 12 months.
Detailed description
The management of anoperineal suppurations of Crohn's disease is most often based on clinical practice recommendations, the results of randomized controlled trials and also the analysis of monocentric cohort studies from expert centres. In these latter studies, there is an overall improvement in patients during follow-up with a high level of satisfaction (two thirds of cases), often assessed by the operator himself or the clinician who provides therapeutic management. The most striking finding is the one that highlights the use of combined therapeutic strategies combining immunosuppressants, biotherapies, antibiotics, surgical drainage and surgical reconstruction procedures to varying degrees. Thus, the absence of fistula pathway flow in the long term is the consequence of both maintenance treatment with biotherapies and several surgical procedures. When the characteristics of fistula pathways considered healed on clinical examination are analysed by MRI exploration, an active unhealed pathway persists in two thirds of cases, again emphasizing the inadequacy of clinical examination as a means of assessing recovery. For this reason, fistula pathway closure strategies do not provide much greater benefit than simple removal of the drainage loop. Conversely, medical treatment optimization strategies based on MRI evaluation of the therapeutic response have demonstrated high efficacy. It is necessary to (re)define the therapeutic management of patients with anoperineal lesions. This strategy must be based on a better initial stratification of patients based on prognostic factors derived from available scientific data. A second step consists in setting therapeutic efficacy objectives that take into account the control of the inflammatory component of anal Crohn's disease and the preservation of the anatomical and functional capital of the anus. Only a large prospective cohort at the national level provides the opportunity to study these prognostic factors and to specify the level of optimal therapeutic responses
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Person suffering from anal suppuration related to Crohn's Disease
Key inclusion criteria (3 listed)
- Persons over 18 years of age
- People suffering from anal suppuration of Crohn's disease for whom a drainage procedure is planned.
- Person who has received written and oral information about the protocol and has not expressed opposition to participate in the study.
Key exclusion criteria (4 listed)
- No one who is unable to have an anesthetic, structural or psychological examination by MRI and/or surgery.
- Person planning a planned absence that could hinder participation in the research (travel abroad, relocation, impending transfer);
- Person with an associated pathology that is a priority for care;
- Vulnerable person (minors, persons under guardianship or curatorship, or deprived of their liberty by a judicial or administrative decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical treatmentsurgical drainage and/or surgical reconstruction procedures to anoperineal suppurations according to the doctor's decision | Procedure or surgery | – |
Primary outcome
Clinical and anatomical healing
Time frame: 12 months.
The healing of anal fistula is defined by the combination of two criteria at 12 months : * MRI criteria = absence of a T2 hyper signal from the path(s) AND the absence of an abscess AND * Complete clinical response = no pain, no discharge, and no drain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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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.
Laurent SIPROUDHIS, PH-PD principal investigator
Rennes University Hospital
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 Crohn Disease and Anal Suppurations, run by Rennes University Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 12 Apr 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kristell COAT (299282555 ext. 33, kristell.coat@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and anatomical healing (time frame: 12 months.). 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 12 Apr 2023.