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

July 6, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Helene BEAUSSIER, PharmD, PhD
  • Phone Number: +33 144127901
  • Email: crc@ghpsj.fr

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Groupe Hospitalier Paris Saint-Joseph
        • Contact:
          • Nadia FATHALLAH, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Reference Strategy
Detailed examination of the suppuration and drainage with a seton
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.
Experimental: Group test strategy
Detailed examination of the suppuration without drainage via 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life in Crohn's disease patients undergoing surgery for an anal fistula
Time Frame: Month 12
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
Time Frame: Month 6
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
Time Frame: Month 12
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
Time Frame: Month 12
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
Time Frame: Month 12
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
Time Frame: Month 12
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
Time Frame: Month 12
This outcome corresponds to the Clinical and radiological cure rate (pre-defined criteria).
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Nadia Fathallah, MD, Groupe hospitalier Paris saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2022

Primary Completion (Estimated)

May 24, 2024

Study Completion (Estimated)

May 24, 2025

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

April 8, 2022

First Posted (Actual)

April 15, 2022

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOPA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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