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NCT Number: NCT04192825

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Rennes

Rennes, 35000, France

Location status: Recruiting

Location contact

Céline Gautier

CONTACT

2992843 21 ext. +33

Laurent Siproudhis, PH-PD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surgical treatment

Procedure

surgical drainage and/or surgical reconstruction procedures to anoperineal suppurations according to the doctor's decision

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Direction de la recherche

CONTACT

[email protected]

299282555 ext. 33

kristell COAT

CONTACT

[email protected]

299282555 ext. 33

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: 3T-LAP

Important dates

Study start
2020
Primary completion
2025
Study completion
2028
First posted
Dec 10, 2019
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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