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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Jessica
Thut
jessica.thut@nhs.net
Amy
Wilkinson
amy.wilkinson18@nhs.net
Prof
shaji
sebastian
Shaji.sebastian4@nhs.net
Noninfective enteritis and colitisOther diseases of intestines
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Perianal fistula in Crohn's Disease (CD-pAF) is an abnormal tunnel that develops between the end of the bowel and the skin near the anus. It affects one third of Crohn's Disease (CD) patients causing significant morbidity and poor quality of life. Patients with CD-pAF are treated with several combined approaches involving medical and various surgical techniques with high failure rates (around 50%). The study will provide an evidence base to identify predictors of fistula healing, potentially modifiable factors, patient and care provider perspectives and develop future treatment strategies. All eligible patients will be provided with a ‘Patient Information Sheet’, with the opportunity to ask questions. Subjects who wish to proceed will be asked to complete an informed consent form as per GCP-ICH guidance. Anonymised patient data such as demographics, disease particulars, imaging records, medical and surgical interventions will be collected and entered into a secured electronic database. Participants recruited into the prospective arm of the study will be asked to complete a series of validated questionnaires at the following time points: 0, 6, 12, 24, and 36 months to measure quality of life and disease impact. Participants enrolled to the retrospective arm of the study will be asked to complete these questionnaires once at the time of recruitment. The study will run for 5 years. Retrospective study group - Patients with pre-existing CD-pAF identified through the Bioresource registry or participating NHS site databases and invited to participate in the retrospective arm of the study. Prospective study group - Patients with new diagnosis of CD-pAF (within 6 months at enrolment) are invited into the prospective study cohort and with a new diagnosis of CD without fistula (within 6 months at enrolment) identified at the participating NHS sites will be invited to participate in the control arm of the prospective study group
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Case-controlled study;
You can take part if:
You may not be able to take part if:
Any patient under the age of 16 years inability to provide informed consent
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Jessica
Thut
jessica.thut@nhs.net
Amy
Wilkinson
amy.wilkinson18@nhs.net
Prof
shaji
sebastian
Shaji.sebastian4@nhs.net
The study is sponsored by HULL UNIVERSITY TEACHING HOSPITALS NHS TRUST and funded by BOWEL DISEASE RESEARCH FOUNDATION .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 49715
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
