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

  • STATUS
    Recruiting
  • End date
    May 24, 2025
  • participants needed
    108
  • sponsor
    Groupe Hospitalier Paris Saint Joseph
Updated on 11 July 2022
drainage
adalimumab
infliximab
crohn's disease
anal fistula

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.

Details
Condition Crohn Disease
Treatment Group Reference Strategy, Group Test Strategy
Clinical Study IdentifierNCT05330416
SponsorGroupe Hospitalier Paris Saint Joseph
Last Modified on11 July 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note