Anal FistulaFISTUCROHNNCT03878498
Management of Anal Fistula of Crohn Disease
An observational study of Anal Fistula and Crohn Disease, run by Rennes University Hospital at 1 site in France.
Trial summary
The management of anal fistula in Crohn Disease is complex. In aim to obtain the healing of the anal fistula, different approaches can be proposed but the best strategy is not yet determined. The aim was to describe the therapeutic management of anal fistula in Crohn Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula, Crohn Disease
- What is being tested?
- therapeutic management
- How many people
- 212 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2018to 19 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with anal fistula in Crohn Disease and needed fistula drainage or surgery
Who may be able to join
- Patient over 18 years of age
- Crohn's disease with fistulizing anoperineal lesion
- Operated at least once for this reason
Who cannot join
- Adult person protected under the Public Health Code
- Minor person
Trial locations and contacts
1 site in 1 country.
About this study
The management of anal fistula in Crohn Disease is complex. In aim to obtain the healing of the anal fistula, different approaches can be proposed but the best strategy is not yet determined. The aim was to describe the therapeutic management of anal fistula in Crohn Disease.
Read the detailed description
Patients with anal fistula with Crohn disease and needed anal fistula drainage will be included. Medical and surgical treatments will be recorded. The management will be described and the best approaches will be identified.
- Conditions
- Anal Fistula, Crohn Disease
- Being tested
- therapeutic management
- Keywords
- Crohn disease, anal fistula, anal surgery
- Medical subject headings
- Rectal Fistula, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic managementOther
therapeutic management of anal fistula in Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the therapeutic management of anal fistula in Crohn Disease
Therapeutic management of anal fistula in Crohn Disease, including medical and surgical treatments
Measured: The inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start19 Jun 2018
- Primary completion19 Sep 2019 (estimated)
- Study completion19 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlène BROCHARD, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878498
- Sponsor's protocol ID
- 35RC18_3041_FISTUCROHN
- Acronym
- FISTUCROHN
- Status last verified
- Mar 2019
- First submitted
- 14 Mar 2019
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Anal Fistula of Crohn Disease
- ClinicalTrials.gov ID
- NCT03878498
- Acronym / sponsor ID
- FISTUCROHN / 35RC18_3041_FISTUCROHN
- Conditions
- Anal Fistula, Crohn Disease
- Keywords
- Crohn disease, anal fistula, anal surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 19 Sep 2019 (estimated)
- Study completion
- 19 Sep 2019 (estimated)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The management of anal fistula in Crohn Disease is complex. In aim to obtain the healing of the anal fistula, different approaches can be proposed but the best strategy is not yet determined. The aim was to describe the therapeutic management of anal fistula in Crohn Disease.
Detailed description
Patients with anal fistula with Crohn disease and needed anal fistula drainage will be included. Medical and surgical treatments will be recorded. The management will be described and the best approaches will be identified.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with anal fistula in Crohn Disease and needed fistula drainage or surgery
Key inclusion criteria (3 listed)
- Patient over 18 years of age
- Crohn's disease with fistulizing anoperineal lesion
- Operated at least once for this reason
Key exclusion criteria (2 listed)
- Adult person protected under the Public Health Code
- Minor person
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic managementtherapeutic management of anal fistula in Crohn Disease | Other | – |
Primary outcome
Description of the therapeutic management of anal fistula in Crohn Disease
Time frame: The inclusion day
Therapeutic management of anal fistula in Crohn Disease, including medical and surgical treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
Related trials for Anal Fistula
Active, not recruitingPhase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Anal Fistula
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
Recruiting
The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
Anal Fistula Surgery, Anal Fistula
Not yet recruiting
Seton Re-routing for High Perianal Fistula
High Perianal Fistula, Fistula-in-Ano
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlène BROCHARD, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fistula and Crohn Disease, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the therapeutic management of anal fistula in Crohn Disease (time frame: The inclusion day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.