Anal Crohn Fistula Surgery

NCT01388257 | Unknown

• 1 other identifier: SNFCP-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Crohn Disease; Fistula; Anoperineal Fistula; Anal Fistula

Keywords

Crohn Disease; Anoperineal fistula; Anal fistula; Proctology; Drainage; Colorectal Surgery; Fistulotomy; Plug; Advancement flap; Glue; Anti Tumor Necrosis Factor-alpha; Adalimumab

Outcome Measures

Primary Outcomes (1)

• Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease

  12 months after seton drain removal

Secondary Outcomes (7)

• Proportion of patients having more than half of their fistulas healed

  3, 6, 12 and 24 months after seton drain removal

• Change in Crohn disease activity assessed by Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI)

  3, 6, 12 and 24 months after seton drain removal

• Change in anal continence assessed by Wexner and Vaizey scores

  12 and 24 months after seton drain removal

• Crohn's Disease Endoscopic Index of Severity (CDEIS)

  12 months after seton drain removal

• Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)

  12 and 24 months after seton drain removal

Study Arms (2)

Surgery

EXPERIMENTAL

Seton drain removal is associated with proctological surgery.

Procedure: All types of surgery procedures

Simple seton drain removal

OTHER

Procedure: Simple seton drain removal

Interventions

All types of surgery procedures PROCEDURE

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

Surgery

Simple seton drain removal PROCEDURE

Patients are simply followed after seton drain removal.

Simple seton drain removal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• French Society of Coloproctology: lead

Study Sites (15)

CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology

Bordeaux, Aquitaine, 33075, France

RECRUITING

Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology

Talence, Aquitaine, 33401, France

RECRUITING

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

Grenoble, Auvergne-Rhône-Alpes, 38043, France

RECRUITING

CHU Pontchaillou - Department of Digestive Diseases

Rennes, Brittany Region, 35033, France

NOT YET RECRUITING

Polyclinique de Franche-Comté - Department of Proctological Surgery

Besançon, Franche-Comté, 25052, France

NOT YET RECRUITING

CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition

Rouen, Haute Normandie, 76031, France

NOT YET RECRUITING

Clinique des Cèdres - Hepato-Gastroenterology Department

Cornebarrieu, Midi-Pyrénées, 31700, France

RECRUITING

Clinique Saint Jean Languedoc - Department of Gastroenterology

Toulouse, Midi-Pyrénées, 31077, France

NOT YET RECRUITING

Hôpital Nord de Marseille - Gastroenterology Department

Marseille, 13915, France

NOT YET RECRUITING

Hôpital de POISSY

Poissy, 78303, France

NOT YET RECRUITING

Polyclinique de l'Océan

Saint-Nazaire, 44600, France

NOT YET RECRUITING

Hôpital Louis Mourier - Department of Hepato-Gastroentérologie

Colombes, Île-de-France Region, 92700, France

NOT YET RECRUITING

Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology

Paris, Île-de-France Region, 75014, France

RECRUITING

Institut Mutualiste Montsouris - Proctology Unit

Paris, Île-de-France Region, 75014, France

NOT YET RECRUITING

Hôpital Bichat-Claude Bernard - Gastro-enterology Department

Paris, Île-de-France Region, 75877, France

RECRUITING

Related Publications (1)

• Abramowitz L, Brochard C, Pigot F, Roumeguere P, Pillant H, Vinson Bonnet B, Faucheron JL, Senejoux A, Bonnaud G, Meurette G, Fayette JM, Train C, Staumont G, Siproudhis L, Bouchard D. Surgical closure, mainly with glue injection and anti-tumour necrosis factor alpha, in fistulizing perianal Crohn's disease: A multicentre randomized controlled trial. Colorectal Dis. 2022 Feb;24(2):210-219. doi: 10.1111/codi.15947. Epub 2021 Oct 23.

  PMID: 34623746 DERIVED

MeSH Terms

Conditions

Crohn Disease; Fistula; Rectal Fistula

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Fistula; Digestive System Fistula; Rectal Diseases

Study Officials

• Laurent Abramowitz, MD

  Hôpital Bichat-Claude Bernard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent Abramowitz, MD

CONTACT

140 50 11 22; laurent.abramowitz@bch.ap-hop-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2011
• First Posted: July 6, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2017
• Last Updated: June 7, 2012

Record last verified: 2012-06

Locations

FR (15)