GONDOMAR: Goals, Needs and outcome Determinants Of Multimodal therapy in Perianal Crohn's fistula - A multicentre cohort study (GONDOMAR)

Research summary

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

Principal Investigator

Dr Oliver Brain

Contact us

Email: ctf.research@ouh.nhs.uk

IRAS number

300534