Comparison of Quality of Life With or Without Automatic Seton Placement in Perianal Crohn's Fistula

NCT05330416 | Unknown

• 1 other identifier: SOPA
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with Crohn's disease, anal fistulas are usually treated in three stages: 1) close examination of the fistula and drainage with a seton, 2) pharmacological treatment of the inflammatory component, and 3) closure of the fistulous tract by a sphincter-sparing technique. Setons are used to ensure the permeability of the fistulous tract, to decrease the rate of re-intervention due to the formation of new abscesses or tracts. A seton is a small, often elastic, thread used for drainage. It is inserted into the fistulous tract, passing from the external orifice of the fistula (close to the anus or, in some cases, the vaginal) through the fistula and exiting via the anal orifice. Seton use seems to minimize colonization of the mucosa of the fistulous tract by the intestinal flora, leukocyte infiltration, and the spread of inflammation within the fistulous tract. Most clinical practice guidelines advocate the use of a seton, but the level of evidence for the efficacy of this approach remains low (D, EL5). Indeed, only a few open studies have reported seton use to be potentially beneficial. In the retrospective study of 32 patients by Regueiro et al., a surgery group with seton insertion before treatment with infliximab was compared with a group on infliximab, without a seton, from the outset. Response rates were better in the group of patients with a seton, with a lower rate of recurrence and a longer time to recurrence than for the seton-less group. Another retrospective study by Schwartz et al. compared two groups - seton (n = 326) and no seton (n = 1519) - in patient with at least six months of biotherapy in three states of the USA. There were more hospitalizations and higher costs generated by greater use of the healthcare system in the group treated without a seton than in those with a seton. The systematic use of setons in the context of Crohn's disease was inspired by the management of cryptoglandular fistula. However, the protective value of setons in this context remains far from clear, due to a lack of studies providing high-level evidence. Furthermore, the impact of seton use on patient quality of life has been little evaluated. Investigators aim to determine whether the insertion of one or more setons in anal fistulas in Crohn's disease patients significantly alters patient quality of life. Investigators will perform a randomized controlled trial comparing two strategies: drainage surgery with and without seton use.

Conditions

Crohn Disease

Keywords

Quality of life; Surgery; Seton

Outcome Measures

Primary Outcomes (1)

• Quality of life in Crohn's disease patients undergoing surgery for an anal fistula

  This outcome corresponds to the comparison of quality of life with The Crohn's Anal Fistula Quality of Life (CAF-QoL) scale with 28 simple questions covering three areas: fistula-related symptoms, treatment-related symptoms and quality of life. The CAF-QoL scale is ready for use as a PROM in research and clinical practice. It complements objective clinical evaluation of fistula by capturing impact on the patient.

  Month 12

Secondary Outcomes (6)

• Clinical cure rate at 6 months

  Month 6

• Clinical cure rate at 12 months

  Month 12

• Rate of re-interventions for the drainage of a new abscess or a new fistula at 12 months

  Month 12

• Radiological cure rate, as determined by MRI at 12 months

  Month 12

• Rate of use of sphincter-sparing techniques at 12 months

  Month 12

Study Arms (2)

Group Reference Strategy

ACTIVE COMPARATOR

Detailed examination of the suppuration and drainage with a seton

Device: Group Reference Strategy

Group test strategy

EXPERIMENTAL

Detailed examination of the suppuration without drainage via a seton

Other: Group Test Strategy

Interventions

Group Reference Strategy DEVICE

Patients undergoing surgery for anoperineal suppuration in the context of Crohn's disease with detailed examination of the suppuration and drainage with a seton.

Group Reference Strategy

Group Test Strategy OTHER

Patients undergoing surgery for anoperineal suppuration in the context of Crohn's disease with detailed examination of the suppuration without drainage via a seton.

Group test strategy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an anal fistula requiring surgical management in the context of Crohn's disease, with or without anti-TNF treatment (infliximab or adalimumab)
• Patient over 16 years of age (for minors, the consent of one of the parents will be requested)
• Patient with health insurance coverage
• French-speaking patient
• Signed written informed consent

You may not qualify if:

• Patient already included in a type 1 interventional research protocol (RIPH1)
• Patient under guardianship or curatorship
• Patient incarcerated
• Patient under legal protection
• Patient refusing randomization or follow-up
• Patient refusing the medical protocol for anti-TNF treatment (infliximab or adalimumab)
• Patient already experiencing treatment failure on optimized infliximab treatment; by contrast, those experiencing treatment failure on adalimumab alone may be included
• Patient allergic or intolerant to the two anti-TNF agents (infliximab and adalimumab)
• Patient with a stoma
• Patient with an ano-recto-vaginal fistula
• Patient with anal or rectal stenosis
• Patient with ileo-anal anastomosis
• Patient without preoperative MRI

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

RECRUITING

Related Publications (5)

• Torres J, Bonovas S, Doherty G, Kucharzik T, Gisbert JP, Raine T, Adamina M, Armuzzi A, Bachmann O, Bager P, Biancone L, Bokemeyer B, Bossuyt P, Burisch J, Collins P, El-Hussuna A, Ellul P, Frei-Lanter C, Furfaro F, Gingert C, Gionchetti P, Gomollon F, Gonzalez-Lorenzo M, Gordon H, Hlavaty T, Juillerat P, Katsanos K, Kopylov U, Krustins E, Lytras T, Maaser C, Magro F, Marshall JK, Myrelid P, Pellino G, Rosa I, Sabino J, Savarino E, Spinelli A, Stassen L, Uzzan M, Vavricka S, Verstockt B, Warusavitarne J, Zmora O, Fiorino G. ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. J Crohns Colitis. 2020 Jan 1;14(1):4-22. doi: 10.1093/ecco-jcc/jjz180. No abstract available.

  PMID: 31711158 BACKGROUND

• Adamina M, Bonovas S, Raine T, Spinelli A, Warusavitarne J, Armuzzi A, Bachmann O, Bager P, Biancone L, Bokemeyer B, Bossuyt P, Burisch J, Collins P, Doherty G, El-Hussuna A, Ellul P, Fiorino G, Frei-Lanter C, Furfaro F, Gingert C, Gionchetti P, Gisbert JP, Gomollon F, Gonzalez Lorenzo M, Gordon H, Hlavaty T, Juillerat P, Katsanos K, Kopylov U, Krustins E, Kucharzik T, Lytras T, Maaser C, Magro F, Marshall JK, Myrelid P, Pellino G, Rosa I, Sabino J, Savarino E, Stassen L, Torres J, Uzzan M, Vavricka S, Verstockt B, Zmora O. ECCO Guidelines on Therapeutics in Crohn's Disease: Surgical Treatment. J Crohns Colitis. 2020 Feb 10;14(2):155-168. doi: 10.1093/ecco-jcc/jjz187.

  PMID: 31742338 BACKGROUND

• Bouchard D, Abramowitz L, Bouguen G, Brochard C, Dabadie A, de Parades V, Eleouet-Kaplan M, Fathallah N, Faucheron JL, Maggiori L, Panis Y, Pigot F, Roumeguere P, Senejoux A, Siproudhis L, Staumont G, Suduca JM, Vinson-Bonnet B, Zeitoun JD. Anoperineal lesions in Crohn's disease: French recommendations for clinical practice. Tech Coloproctol. 2017 Sep;21(9):683-691. doi: 10.1007/s10151-017-1684-y. Epub 2017 Sep 19.

  PMID: 28929282 BACKGROUND

• Lee MJ, Heywood N, Sagar PM, Brown SR, Fearnhead NS; pCD Collaborators. Surgical management of fistulating perianal Crohn's disease: a UK survey. Colorectal Dis. 2017 Mar;19(3):266-273. doi: 10.1111/codi.13462.

  PMID: 27423057 BACKGROUND

• Gecse KB, Bemelman W, Kamm MA, Stoker J, Khanna R, Ng SC, Panes J, van Assche G, Liu Z, Hart A, Levesque BG, D'Haens G; World Gastroenterology Organization, International Organisation for Inflammatory Bowel Diseases IOIBD, European Society of Coloproctology and Robarts Clinical Trials; World Gastroenterology Organization International Organisation for Inflammatory Bowel Diseases IOIBD European Society of Coloproctology and Robarts Clinical Trials. A global consensus on the classification, diagnosis and multidisciplinary treatment of perianal fistulising Crohn's disease. Gut. 2014 Sep;63(9):1381-92. doi: 10.1136/gutjnl-2013-306709. Epub 2014 Jun 20.

  PMID: 24951257 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Nadia Fathallah, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Fathallah, MD

CONTACT

1 44 12 71 83; nfathallah@ghpsj.fr

Helene BEAUSSIER, PharmD, PhD

CONTACT

144127901; crc@ghpsj.fr

Study Design

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

Model Details: Randomized, open-label, single-center, controlled, superiority study comparing quality of life in two groups of patients operated on for ano-perineal suppuration in Crohn's disease: * Flattening of the suppuration and drainage with a suture (reference strategy) * Flattening of the suppuration without drainage with a nipple (evaluated strategy)

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: May 25, 2022
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2025
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

FR (1)