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

Study Overview
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Brief Summary
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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.

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

Conditions
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Crohn Disease

Intervention / Treatment
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* Device: Group Reference Strategy
* Other: Group Test Strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Reference Strategy<br>Detailed examination of the suppuration and drainage with a seton | Device: Group Reference Strategy<br>* Patients undergoing surgery for anoperineal suppuration in the context of Crohn's disease with detailed examination of the suppuration and drainage with a seton.<br>|
| Experimental: Group test strategy<br>Detailed examination of the suppuration without drainage via a seton | Other: Group Test Strategy<br>* Patients undergoing surgery for anoperineal suppuration in the context of Crohn's disease with detailed examination of the suppuration without drainage via a seton.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate at 6 months | This outcome corresponds to Clinical cure defined by: absence of seton, closure of secondary orifices, absence of leakage under pressure and absence of new suppuration. | Month 6 | 
| Clinical cure rate at 12 months | This outcome corresponds to Clinical cure defined by: absence of seton, closure of secondary orifices, absence of leakage under pressure and absence of new suppuration. | Month 12 | 
| Rate of re-interventions for the drainage of a new abscess or a new fistula at 12 months | This outcome corresponds to the Number of re-interventions for the drainage of a new abscess and/or fistula (operations to close the fistulous tract excluded). | Month 12 | 
| Radiological cure rate, as determined by MRI at 12 months | This outcome corresponds to the absence of T2 hyperintensity, contrast uptake after injection of gadolinium and abscess > 2 cm. | Month 12 | 
| Rate of use of sphincter-sparing techniques at 12 months | This outcome corresponds to the rate of use of sphincter-sparing techniques (simple removal of the seton, rectal lowering flap, FiLaC laser, biological glue, intersphincter ligation of the fistulous tract, injection of mesenchymal stem cells). | Month 12 | 
| Clinical and radiological cure rate at 12 months in the group of patients receiving an injection of mesenchymal stem cells | This outcome corresponds to the Clinical and radiological cure rate (pre-defined criteria). | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Surgery, Seton