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Analysis of Therapeutic Management Strategies for Anal Suppurations of Crohn's Disease (3T-LAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04192825
Recruitment Status : Not yet recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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

Condition or disease Intervention/treatment
Crohn Disease Anal Suppurations Drainage Procedure Procedure: surgical treatment

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

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Study Type : Observational
Estimated Enrollment : 440 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Therapeutic Management Strategies for Anal Suppurations of Crohn's Disease
Estimated Study Start Date : December 10, 2019
Estimated Primary Completion Date : December 10, 2023
Estimated Study Completion Date : December 10, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease


Intervention Details:
  • Procedure: surgical treatment
    surgical drainage and/or surgical reconstruction procedures to anoperineal suppurations according to the doctor's decision


Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Person suffering from anal suppuration related to Crohn's Disease
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04192825


Contacts
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Contact: kristell COAT 299282555 ext 33 kristell.coat@chu-rennes.fr
Contact: Direction de la recherche 299282555 ext 33 drc@chu-rennes.fr

Locations
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France
Centre Hospitalier de Rennes
Rennes, France, 35000
Contact: Céline Gautier    2992843 21 ext +33      
Principal Investigator: Laurent Siproudhis, PH-PD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Laurent SIPROUDHIS, PH-PD Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04192825    
Other Study ID Numbers: 35RC18_8808_3T-LAP
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suppuration
Infection
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Inflammation
Pathologic Processes