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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Experimental | Seton drain removal is associated with proctological surgery. |
|
| Simple seton drain removal | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease | 12 months after seton drain removal |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurent Abramowitz, MD | Contact | 140 50 11 22 | +33 | laurent.abramowitz@bch.ap-hop-paris.fr |
| Name | Affiliation | Role |
|---|---|---|
| Laurent Abramowitz, MD | Hôpital Bichat-Claude Bernard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology | Recruiting | Bordeaux | Aquitaine | 33075 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34623746 | Derived | 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. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D005402 | Fistula |
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Simple seton drain removal | Procedure | Patients are simply followed 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 |
| 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 | 6, 12 and 24 months after seton drain removal |
| Change in discomfort and impact assessed by the patient using a visual analog scale (VAS) | 3, 6, 12 and 24 months after seton drain removal |
| Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology | Recruiting | Talence | Aquitaine | 33401 | France |
|
| Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit | Recruiting | Grenoble | Auvergne-Rhône-Alpes | 38043 | France |
|
| CHU Pontchaillou - Department of Digestive Diseases | Not yet recruiting | Rennes | Brittany Region | 35033 | France |
|
| Polyclinique de Franche-Comté - Department of Proctological Surgery | Not yet recruiting | Besançon | Franche-Comté | 25052 | France |
|
| CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition | Not yet recruiting | Rouen | Haute Normandie | 76031 | France |
|
| Clinique des Cèdres - Hepato-Gastroenterology Department | Recruiting | Cornebarrieu | Midi-Pyrénées | 31700 | France |
|
| Clinique Saint Jean Languedoc - Department of Gastroenterology | Not yet recruiting | Toulouse | Midi-Pyrénées | 31077 | France |
|
| Hôpital Nord de Marseille - Gastroenterology Department | Not yet recruiting | Marseille | 13915 | France |
|
| Hôpital de POISSY | Not yet recruiting | Poissy | 78303 | France |
|
| Polyclinique de l'Océan | Not yet recruiting | Saint-Nazaire | 44600 | France |
|
| Hôpital Louis Mourier - Department of Hepato-Gastroentérologie | Not yet recruiting | Colombes | Île-de-France Region | 92700 | France |
|
| Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology | Recruiting | Paris | Île-de-France Region | 75014 | France |
|
| Institut Mutualiste Montsouris - Proctology Unit | Not yet recruiting | Paris | Île-de-France Region | 75014 | France |
|
| Hôpital Bichat-Claude Bernard - Gastro-enterology Department | Recruiting | Paris | Île-de-France Region | 75877 | France |
|
| D007410 | Intestinal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D012002 | Rectal Diseases |