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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2025-05-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of the 12-month Efficacy of Stem Cell Injection in Crohn's Disease With Complex Ano-perineal Fistula

NCT05177003

Crohn Disease Ano Fistula

UNKNOWN

A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas

NCT04876690

Crohn Disease Rectal Fistula

COMPLETED

Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population

NCT05759104

Crohn Disease

UNKNOWN

Study on the Long-Term Risk of Recurrence of Anoperineal Fistula in Crohn's Disease

NCT06514092

Crohn Disease

RECRUITING

Endoscopic Stricturotomy Versus Endoscopic Balloon Dilatation in Patients With Crohn's Disease and Symptomatic Small Bowel Stricture

NCT05009212

Crohn Disease Stricture; Bowel Endoscopy, Gastrointestinal

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group Reference Strategy

Detailed examination of the suppuration and drainage with a seton

Group Type ACTIVE_COMPARATOR

Group Reference Strategy

Intervention Type 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 test strategy

Detailed examination of the suppuration without drainage via a seton

Group Type EXPERIMENTAL

Group Test Strategy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Group Reference Strategy

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

Intervention Type DEVICE

Group Test Strategy

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No