NCT06514092

Brief Summary

This research aims to evaluate the long-term recurrence risk of perianal fistulas in Crohn's disease patients who have undergone treatment with anti-TNF therapy and seton drainage.The research seeks to identify factors influencing recurrence and assess the long term effectiveness of these treatments in preventing fistula recurrence. This study will provide insights that could enhance treatment strategies and improve patient outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
15mo left

Started Sep 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Sep 2024Aug 2027

First Submitted

Initial submission to the registry

July 11, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 17, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

2.9 years

First QC Date

July 11, 2024

Last Update Submit

January 6, 2025

Conditions

Crohn Disease

Keywords

perianal fistulaanti-TNFseton drainageinflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

  • Long-term recurrence-free survival rate of perianal fistulas

    To evaluate the long-term recurrence-free survival rate of perianal fistulas after combined treatment with anti-TNF alpha and seton drainage

    through study completion, an average of 2 years

Study Arms (1)

Crohn's patients

Other: anti-TNF therapy and seton drainage

Interventions

anti-TNF therapy and seton drainageOTHER

Crohn's disease patients who have undergone treatment with anti-TNF therapy and seton drainage.

Crohn's patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with crohn's disease

You may qualify if:

  • Confirmed diagnosis of Crohn's disease
  • drainage of an anal fistula with seton combined with the initiation of anti-TNF alpha treatment
  • Patient who was treated in the digestive center of the Toulouse University Hospital for drainage of an anal fistula between January 1, 2000 and December 31, 2010

You may not qualify if:

  • Patient followed less than 6 months after seton drainage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Guillaume LE COSQUER, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume LE COSQUER, MD

CONTACT

05 61 32 20 45lecosquer.g@chu-toulouse.fr

Tevin POLYNICE

CONTACT

polynice.t@chu-toulouse.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 23, 2024

Study Start

September 17, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations

FR(1)