Description of the Radiological Response of Anoperineal Fistulizing Lesions of Crohn's Disease (NCT07152977) | Clinical Trial Compass
CompletedNot Applicable
Description of the Radiological Response of Anoperineal Fistulizing Lesions of Crohn's Disease
France52 participantsStarted 2019-07-31
Plain-language summary
The presence of ano-perineal lesions (APL) in Crohn's disease is common and represents a major burden for the patient. More than one-third of patients with Crohn's disease will develop at least one ano-perineal lesion during the course of their disease. The cumulative incidence of APL is approximately 30% at 10 years and 43% at 20 years, regardless of the type of APL.
The appearance of ano-perineal lesions represents an important phase in the progression of Crohn's disease, but they have been little studied to date. There is little consensus regarding their overall management. Indeed, their management is difficult due to their destructive and recurrent nature, and their significant impact on patients' quality of life, continence, and sexuality is significant. The presence of ano-perineal lesions at the time of diagnosis, especially in young patients, is a poor prognostic factor.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All adult patients, monitored at the Rouen University Hospital for Crohn's disease, complicated by fistulizing anoperineal lesion, treated with Biotherapy, having benefited from an MRI at the start of treatment and during follow-up.
Exclusion Criteria:
* Minor patients
* Patients with an anoperineal lesion, without Crohn's disease
* Patients who have received surgical treatment with a stoma for perineal disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiological evolution of patients
Timeframe: at the enrollment visit, at the 1-year visit and at the 3-year visit