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

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ClinicalTrials.gov Identifier: NCT05330416
Recruitment Status : Recruiting
First Posted : April 15, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief 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.


Condition or disease Intervention/treatment Phase
Crohn Disease Device: Group Reference Strategy Other: Group Test Strategy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Quality of Life With or Without Automatic Seton Placement in Perianal Crohn's Fistula
Actual Study Start Date : May 25, 2022
Estimated Primary Completion Date : May 24, 2024
Estimated Study Completion Date : May 24, 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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).

  6. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05330416


Contacts
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Contact: Nadia Fathallah, MD 1 44 12 71 83 ext +33 nfathallah@ghpsj.fr
Contact: Helene BEAUSSIER, PharmD, PhD 144127901 ext +33 crc@ghpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: Nadia Fathallah, MD         
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Nadia Fathallah, MD Groupe Hospitalier Paris Saint Joseph
Publications:

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT05330416    
Other Study ID Numbers: SOPA
First Posted: April 15, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
Quality of life
Surgery
Seton
Additional relevant MeSH terms:
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Crohn Disease
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical