Analysis of Therapeutic Management Strategies for Anal Suppurations of Crohn's Disease

Study Purpose

Determine the optimal therapeutic combination associated with complete clinical and anatomical remission of anal suppurations of Crohn's disease at 12 months.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04192825
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rennes University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Laurent SIPROUDHIS, PH-PD
Principal Investigator Affiliation Rennes University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease, Anal Suppurations, Drainage Procedure
Additional Details

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

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International Sites

Centre Hospitalier de Rennes, Rennes, France

Status

Address

Centre Hospitalier de Rennes

Rennes, , 35000

Site Contact

Céline Gautier

kristell.coat@chu-rennes.fr

2992843 21 #+33

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