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Anal Crohn Fistula Surgery (FACC)

Primary Purpose

Crohn Disease, Fistula, Anoperineal Fistula

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

All types of surgery procedures

Simple seton drain removal

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Crohn Disease, Anoperineal fistula, Anal fistula, Proctology, Drainage, Colorectal Surgery, Fistulotomy, Plug, Advancement flap, Glue, Anti Tumor Necrosis Factor-alpha, Adalimumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHU Bordeaux - Hôpital Saint André - Department of Hepato GastroenterologyRecruiting
Maison de Santé Protestante de Bordeaux Bagatelle - Department of ProctologyRecruiting
CHU Pontchaillou - Department of Digestive Diseases
Polyclinique de Franche-Comté - Department of Proctological Surgery
CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition
Hôpital Louis Mourier - Department of Hepato-Gastroentérologie
Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-ProctologyRecruiting
Institut Mutualiste Montsouris - Proctology Unit
Hôpital Bichat-Claude Bernard - Gastro-enterology DepartmentRecruiting
Clinique des Cèdres - Hepato-Gastroenterology DepartmentRecruiting
Clinique Saint Jean Languedoc - Department of Gastroenterology
Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery UnitRecruiting
Hôpital Nord de Marseille - Gastroenterology Department
Hôpital de POISSY
Polyclinique de l'Océan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Surgery

Simple seton drain removal

Arm Description

Seton drain removal is associated with proctological surgery.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients having more than half of their fistulas healed

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

Change in anal continence assessed by Wexner and Vaizey scores

Crohn's Disease Endoscopic Index of Severity (CDEIS)

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

Change in fistula activity assessed by magnetic resonance imaging (MRI)

Change in fistula activity assessed by MRI (Van Assche score and absence of contrast enhancement after injection of gadolinium with regards to fistulous tract

Change in discomfort and impact assessed by the patient using a visual analog scale (VAS)

Full Information

NCT ID

NCT01388257

First Posted

July 4, 2011

Last Updated

June 6, 2012

Sponsor

French Society of Coloproctology

1. Study Identification

Unique Protocol Identification Number

NCT01388257

Brief Title

Anal Crohn Fistula Surgery

Acronym

FACC

Official Title

A National, Multicenter, Randomized Open-Label Study of Proctological Surgery Efficacy on Anoperineal Fistulas Healing in Crohn's Disease Patients Treated With Adalimumab. (Official French Title: "Étude Nationale, Multicentrique, randomisée et en Ouvert de l'efficacité de la Chirurgie Proctologique Sur la Cicatrisation Des Fistules anopérinéales de la Maladie de Crohn Chez Des Patients traités Par Adalimumab")

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

October 2011 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

French Society of Coloproctology

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgery

Arm Type

Experimental

Arm Description

Seton drain removal is associated with proctological surgery.

Arm Title

Simple seton drain removal

Arm Type

Other

Intervention Type

Procedure

Intervention Name(s)

All types of surgery procedures

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Simple seton drain removal

Intervention Description

Patients are simply followed after seton drain removal.

Primary Outcome Measure Information:

Title

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

Time Frame

12 months after seton drain removal

Secondary Outcome Measure Information:

Title

Proportion of patients having more than half of their fistulas healed

Time Frame

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

Title

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

Time Frame

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

Title

Change in anal continence assessed by Wexner and Vaizey scores

Time Frame

12 and 24 months after seton drain removal

Title

Crohn's Disease Endoscopic Index of Severity (CDEIS)

Time Frame

12 months after seton drain removal

Title

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

Time Frame

12 and 24 months after seton drain removal

Title

Change in fistula activity assessed by magnetic resonance imaging (MRI)

Description

Change in fistula activity assessed by MRI (Van Assche score and absence of contrast enhancement after injection of gadolinium with regards to fistulous tract

Time Frame

6, 12 and 24 months after seton drain removal

Title

Change in discomfort and impact assessed by the patient using a visual analog scale (VAS)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laurent Abramowitz, MD

Phone

140 50 11 22

Ext

+33

laurent.abramowitz@bch.ap-hop-paris.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurent Abramowitz, MD

Organizational Affiliation

Hôpital Bichat-Claude Bernard

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology

City

Bordeaux

State/Province

Aquitaine

ZIP/Postal Code

33075

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roumeguère-Blond

pauline.roumeguere@chu-bordeaux.fr

First Name & Middle Initial & Last Name & Degree

Pauline Roumeguère-Blond, MD

Facility Name

Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology

City

Talence

State/Province

Aquitaine

ZIP/Postal Code

33401

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bouchard

proctobouc@gmail.com

First Name & Middle Initial & Last Name & Degree

Dominique Bouchard, MD

Facility Name

CHU Pontchaillou - Department of Digestive Diseases

City

Rennes

State/Province

Bretagne

ZIP/Postal Code

35033

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Siproudhis

laurent.siproudhis@chu-rennes.fr

First Name & Middle Initial & Last Name & Degree

Laurent Siproudhis, MD, PhD

Facility Name

Polyclinique de Franche-Comté - Department of Proctological Surgery

City

Besançon

State/Province

Franche-Comté

ZIP/Postal Code

25052

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fantoli

drmichelfantoli@wanadoo.fr

First Name & Middle Initial & Last Name & Degree

Michel Fantoli, MD

Facility Name

CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition

City

Rouen

State/Province

Haute Normandie

ZIP/Postal Code

76031

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Savoye

guillaume.savoye@chu-rouen.fr

First Name & Middle Initial & Last Name & Degree

Guillaume Savoye, MD

Facility Name

Hôpital Louis Mourier - Department of Hepato-Gastroentérologie

City

Colombes

State/Province

Ile-de-France

ZIP/Postal Code

92700

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Coffin

benoit.coffin@lmr.ap-hop-paris.fr

First Name & Middle Initial & Last Name & Degree

Benoît Coffin, Prof., MD

Facility Name

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

City

Paris

State/Province

Ile-de-France

ZIP/Postal Code

75014

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sénéjoux

agnes.senejoux@gmail.com

First Name & Middle Initial & Last Name & Degree

Sénéjoux Agnès, MD

Facility Name

Institut Mutualiste Montsouris - Proctology Unit

City

Paris

State/Province

Ile-de-France

ZIP/Postal Code

75014

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Godeberge

philippe.godeberge@wanadoo.fr

First Name & Middle Initial & Last Name & Degree

Philippe Godeberge, MD

Facility Name

Hôpital Bichat-Claude Bernard - Gastro-enterology Department

City

Paris

State/Province

Ile-de-France

ZIP/Postal Code

75877

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurent Abramowitz, MD

Phone

1 43 74 61 41

Ext

+33

laurent.abramowitz@bch.ap-hop-paris.fr

First Name & Middle Initial & Last Name & Degree

Laurent Abramowitz, MD

Facility Name

Clinique des Cèdres - Hepato-Gastroenterology Department

City

Cornebarrieu

State/Province

Midi-Pyrénées

ZIP/Postal Code

31700

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bonnaud

hepavie@free.fr

First Name & Middle Initial & Last Name & Degree

Guillaume Bonnaud, MD

Facility Name

Clinique Saint Jean Languedoc - Department of Gastroenterology

City

Toulouse

State/Province

Midi-Pyrénées

ZIP/Postal Code

31077

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Staumont

staumont.ghislain@orange.fr

First Name & Middle Initial & Last Name & Degree

Ghislain Staumont, MD

Facility Name

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

City

Grenoble

State/Province

Rhône-Alpes

ZIP/Postal Code

38043

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Faucheron

jlfaucheron@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

Jean-Luc Faucheron, Prof., MD

Facility Name

Hôpital Nord de Marseille - Gastroenterology Department

City

Marseille

ZIP/Postal Code

13915

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Charles GRIMAUD, MD

jean-charles.grimaud@ap-hm.fr

First Name & Middle Initial & Last Name & Degree

Jean-Charles GRIMAUD, MD

Facility Name

Hôpital de POISSY

City

Poissy

ZIP/Postal Code

78303

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Béatrice VINSON-BONNET, MD

bvinson-bonnet@chi-psg.com

First Name & Middle Initial & Last Name & Degree

Béatrice VINSON-BONNET, MD

Facility Name

Polyclinique de l'Océan

City

Saint-Nazaire

ZIP/Postal Code

44600

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Florent JURCZAK, MD

florent.jurczak@mla.fr

First Name & Middle Initial & Last Name & Degree

Florent JURCZAK, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34623746

Citation

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.

Results Reference

derived

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Anal Crohn Fistula Surgery

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