Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-28 @ 12:35 PM
Study NCT ID:
NCT01388257
Status:
UNKNOWN
Last Update Posted:
2012-06-07
First Post:
2011-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anal Crohn Fistula Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D012003', 'term': 'Rectal Fistula'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-06', 'studyFirstSubmitDate': '2011-07-04', 'studyFirstSubmitQcDate': '2011-07-04', 'lastUpdatePostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease', 'timeFrame': '12 months after seton drain removal'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients having more than half of their fistulas healed', 'timeFrame': '3, 6, 12 and 24 months after seton drain removal'}, {'measure': "Change in Crohn disease activity assessed by Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI)", 'timeFrame': '3, 6, 12 and 24 months after seton drain removal'}, {'measure': 'Change in anal continence assessed by Wexner and Vaizey scores', 'timeFrame': '12 and 24 months after seton drain removal'}, {'measure': "Crohn's Disease Endoscopic Index of Severity (CDEIS)", 'timeFrame': '12 months after seton drain removal'}, {'measure': "Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)", 'timeFrame': '12 and 24 months after seton drain removal'}, {'measure': 'Change in fistula activity assessed by magnetic resonance imaging (MRI)', 'timeFrame': '6, 12 and 24 months after seton drain removal', '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'}, {'measure': 'Change in discomfort and impact assessed by the patient using a visual analog scale (VAS)', 'timeFrame': '3, 6, 12 and 24 months after seton drain removal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Crohn Disease', 'Anoperineal fistula', 'Anal fistula', 'Proctology', 'Drainage', 'Colorectal Surgery', 'Fistulotomy', 'Plug', 'Advancement flap', 'Glue', 'Anti Tumor Necrosis Factor-alpha', 'Adalimumab'], 'conditions': ['Crohn Disease', 'Fistula', 'Anoperineal Fistula', 'Anal Fistula']}, 'referencesModule': {'references': [{'pmid': '34623746', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male or female 18 years or older,\n* 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)\\],\n* Patient with fistulizing anoperineal Crohn's disease. Anoperineal fistulas can be associated with ileal, colic or rectal lesions,\n* Patient with at least 1 anoperineal fistula drained with a seton for more than 1 month,\n* Patient treated with adalimumab for more than 1 month,\n* Patient who agrees to undergo surgery for its drained fistula(s),\n* Patient with immunosuppressive therapy (azathioprine, 6-mercaptopurine ou methotrexate) stable for at least 3 months or patients without immunosuppressive therapy,\n* Patient who gave signed written informed consent after having received verbal explanation and written information related to the trial.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women,\n* Patient having a perineal abscess,\n* Patient with a high anovaginal fistula that cannot be treated, according to the investigator ,with fistulotomy, gluing, biodegradable plug or advancement flap,\n* 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),\n* Contraindication to proctological surgery on the drained fistula(s),\n* Patient presenting with somatic or psychic signs or symptoms that are not compatible with his/her participation in the trial according to the investigator,\n* Patient who participate in another clinical trial."}, 'identificationModule': {'nctId': 'NCT01388257', 'acronym': 'FACC', 'briefTitle': 'Anal Crohn Fistula Surgery', 'organization': {'class': 'OTHER', 'fullName': 'French Society of Coloproctology'}, 'officialTitle': '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")', 'orgStudyIdInfo': {'id': 'SNFCP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgery', 'description': 'Seton drain removal is associated with proctological surgery.', 'interventionNames': ['Procedure: All types of surgery procedures']}, {'type': 'OTHER', 'label': 'Simple seton drain removal', 'interventionNames': ['Procedure: Simple seton drain removal']}], 'interventions': [{'name': 'All types of surgery procedures', 'type': 'PROCEDURE', 'description': 'All types of surgery procedures used for anoperineal fistula repair. Surgery procedures include fistulotomy, biological glue, rectal advancement flap and plug.', 'armGroupLabels': ['Surgery']}, {'name': 'Simple seton drain removal', 'type': 'PROCEDURE', 'description': 'Patients are simply followed after seton drain removal.', 'armGroupLabels': ['Simple seton drain removal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33075', 'city': 'Bordeaux', 'state': 'Aquitaine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Roumeguère-Blond', 'role': 'CONTACT', 'email': 'pauline.roumeguere@chu-bordeaux.fr'}, {'name': 'Pauline Roumeguère-Blond, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33401', 'city': 'Talence', 'state': 'Aquitaine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bouchard', 'role': 'CONTACT', 'email': 'proctobouc@gmail.com'}, {'name': 'Dominique Bouchard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology', 'geoPoint': {'lat': 44.80849, 'lon': -0.58915}}, {'zip': '38043', 'city': 'Grenoble', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Faucheron', 'role': 'CONTACT', 'email': 'jlfaucheron@chu-grenoble.fr'}, {'name': 'Jean-Luc Faucheron, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit", 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '35033', 'city': 'Rennes', 'state': 'Brittany Region', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Siproudhis', 'role': 'CONTACT', 'email': 'laurent.siproudhis@chu-rennes.fr'}, {'name': 'Laurent Siproudhis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Pontchaillou - Department of Digestive Diseases', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '25052', 'city': 'Besançon', 'state': 'Franche-Comté', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fantoli', 'role': 'CONTACT', 'email': 'drmichelfantoli@wanadoo.fr'}, {'name': 'Michel Fantoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Polyclinique de Franche-Comté - Department of Proctological Surgery', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '76031', 'city': 'Rouen', 'state': 'Haute Normandie', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Savoye', 'role': 'CONTACT', 'email': 'guillaume.savoye@chu-rouen.fr'}, {'name': 'Guillaume Savoye, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31700', 'city': 'Cornebarrieu', 'state': 'Midi-Pyrénées', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bonnaud', 'role': 'CONTACT', 'email': 'hepavie@free.fr'}, {'name': 'Guillaume Bonnaud, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique des Cèdres - Hepato-Gastroenterology Department', 'geoPoint': {'lat': 43.64967, 'lon': 1.32588}}, {'zip': '31077', 'city': 'Toulouse', 'state': 'Midi-Pyrénées', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Staumont', 'role': 'CONTACT', 'email': 'staumont.ghislain@orange.fr'}, {'name': 'Ghislain Staumont, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Saint Jean Languedoc - Department of Gastroenterology', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '13915', 'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Charles GRIMAUD, MD', 'role': 'CONTACT', 'email': 'jean-charles.grimaud@ap-hm.fr'}, {'name': 'Jean-Charles GRIMAUD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Nord de Marseille - Gastroenterology Department', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '78303', 'city': 'Poissy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Béatrice VINSON-BONNET, MD', 'role': 'CONTACT', 'email': 'bvinson-bonnet@chi-psg.com'}, {'name': 'Béatrice VINSON-BONNET, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital de POISSY', 'geoPoint': {'lat': 48.92902, 'lon': 2.04952}}, {'zip': '44600', 'city': 'Saint-Nazaire', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florent JURCZAK, MD', 'role': 'CONTACT', 'email': 'florent.jurczak@mla.fr'}, {'name': 'Florent JURCZAK, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Polyclinique de l'Océan", 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'zip': '92700', 'city': 'Colombes', 'state': 'Île-de-France Region', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Coffin', 'role': 'CONTACT', 'email': 'benoit.coffin@lmr.ap-hop-paris.fr'}, {'name': 'Benoît Coffin, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Louis Mourier - Department of Hepato-Gastroentérologie', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sénéjoux', 'role': 'CONTACT', 'email': 'agnes.senejoux@gmail.com'}, {'name': 'Sénéjoux Agnès, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Godeberge', 'role': 'CONTACT', 'email': 'philippe.godeberge@wanadoo.fr'}, {'name': 'Philippe Godeberge, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Mutualiste Montsouris - Proctology Unit', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75877', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent Abramowitz, MD', 'role': 'CONTACT', 'email': 'laurent.abramowitz@bch.ap-hop-paris.fr', 'phone': '1 43 74 61 41', 'phoneExt': '+33'}, {'name': 'Laurent Abramowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Bichat-Claude Bernard - Gastro-enterology Department', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Laurent Abramowitz, MD', 'role': 'CONTACT', 'email': 'laurent.abramowitz@bch.ap-hop-paris.fr', 'phone': '140 50 11 22', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Laurent Abramowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Bichat-Claude Bernard'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Society of Coloproctology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}