| Interventions |
An eligible patient will be detected at referral or seen in clinic or the ward and offered participation in this study. The study will be explained, discussed and patients encouraged to ask questions for discussion. A trial information sheet will be provided. Patients who decide to enter the study will be required to sign a consent form. The patients who decline to enter the study, will be treated with the normal standard of clinical care provided. For patients who enter the study: At the time of operation or on the ward or in outpatients, biopsies will be taken under local anaesthetic from the enterocuaneous fistulae tracts of non-inflammatory bowel disease and inflammatory bowel disease patients (groups i and ii). A biopsy of the enterocutaneous fistulae tract will be taken to assess for baseline pro- and anti-inflammatory cytokine markers including TNF?a levels. Biopsy forceps will be used to take tissue samples under direct vision from the fistulae tract. We will only take five 2 mm samples. Healthy patients undergoing screening colonoscopy or sigmoidoscopy with normal mucosa endoscopically and histologically will be used as controls. A maximum of ten biopsies will be taken from the colon and/or small intestine in addition to those required for clinical evaluation (group iii). Peripheral blood (2 - 50 ml) will be obtained, taken by a clinician or other trained person from all three groups (groups i, ii and iii). All the patients will have the intervention on one occasion only. Patients will not be followed up after this as the study will not directly affect their outcome, hence follow up is not applicable. |