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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 16 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05330416
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Groupe Hospitalier Paris Saint Joseph
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nadia Fathallah, MD
Principal Investigator Affiliation Groupe Hospitalier Paris Saint Joseph
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Arms & Interventions

Arms

Active Comparator: Group Reference Strategy

Detailed examination of the suppuration and drainage with a seton

Experimental: Group test strategy

Detailed examination of the suppuration without drainage via a seton

Interventions

Device: - 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.

Other: - 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.

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International Sites

Groupe Hospitalier Paris Saint-Joseph, Paris, France

Status

Address

Groupe Hospitalier Paris Saint-Joseph

Paris, , 75014

Site Contact

Nadia Fathallah, MD

nfathallah@ghpsj.fr

1 44 12 71 83

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