Anal Crohn Fistula Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to demonstrate, in patients treated with adalimumab, the efficacy of proctological surgery in anoperineal fistula healing after the removal of seton drain.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Management of Anal Fistula of Crohn Disease

NCT03878498

Anal Fistula Crohn Disease

UNKNOWN

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

NCT04192825

Crohn Disease Anal Suppurations Drainage Procedure

RECRUITING

Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.

NCT04010526

Crohn Disease

RECRUITING PHASE2

Study on the Long-Term Risk of Recurrence of Anoperineal Fistula in Crohn's Disease

NCT06514092

Crohn Disease

RECRUITING

Impact of the Fecal Flora Transplantation on Crohn's Disease

NCT02097797

Crohn's Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn Disease Fistula Anoperineal Fistula Anal Fistula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgery

Seton drain removal is associated with proctological surgery.

Group Type EXPERIMENTAL

All types of surgery procedures

Intervention Type PROCEDURE

All types of surgery procedures used for anoperineal fistula repair. Surgery procedures include fistulotomy, biological glue, rectal advancement flap and plug.

Simple seton drain removal

Group Type OTHER

Simple seton drain removal

Intervention Type PROCEDURE

Patients are simply followed after seton drain removal.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

All types of surgery procedures

All types of surgery procedures used for anoperineal fistula repair. Surgery procedures include fistulotomy, biological glue, rectal advancement flap and plug.

Intervention Type PROCEDURE

Simple seton drain removal

Patients are simply followed after seton drain removal.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* male or female 18 years or older,
* women of childbearing age who use an effective contraception method or women incapable of becoming pregnant \[(i.e. postmenopausal women for 1 year or surgically sterile (hysterectomy and/or bilateral oophorectomy)\],
* Patient with fistulizing anoperineal Crohn's disease. Anoperineal fistulas can be associated with ileal, colic or rectal lesions,
* Patient with at least 1 anoperineal fistula drained with a seton for more than 1 month,
* Patient treated with adalimumab for more than 1 month,
* Patient who agrees to undergo surgery for its drained fistula(s),
* Patient with immunosuppressive therapy (azathioprine, 6-mercaptopurine ou methotrexate) stable for at least 3 months or patients without immunosuppressive therapy,
* Patient who gave signed written informed consent after having received verbal explanation and written information related to the trial.

Exclusion Criteria

* Pregnant or breastfeeding women,
* Patient having a perineal abscess,
* Patient with a high anovaginal fistula that cannot be treated, according to the investigator ,with fistulotomy, gluing, biodegradable plug or advancement flap,
* Patient treated with a daily dose of corticosteroids of more than 20 mg (a dose of more than 20 mg daily will be authorized during the study),
* Contraindication to proctological surgery on the drained fistula(s),
* Patient presenting with somatic or psychic signs or symptoms that are not compatible with his/her participation in the trial according to the investigator,
* Patient who participate in another clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laurent Abramowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bichat-Claude Bernard

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology

Bordeaux, Aquitaine, France

Site Status RECRUITING

Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology

Talence, Aquitaine, France

Site Status RECRUITING

Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit

Grenoble, Auvergne-Rhône-Alpes, France

Site Status RECRUITING