Randomised Controlled Trial of 6-Mercaptopurine versus placebo to prevent recurrence of Crohn's disease following surgic

Crohn s disease is a chronic disabling condition affecting the bowel. Although medical treatment is effective approximately 50% of patient will need an operation to remove an affected segment of bowel over the first 5 years after diagnosis. Recurrence following surgery occurs in the majority of patients. 6-Mercaptopurine is an effective treatment for the reduction of symptoms and maintenance of well being in Crohn s disease but its use to prevent post operative recurrence is poorly defined. Previous studies have been small, retrospective or flawed in design. In this multicentre study we wish to assess the value of the drug 6-mercaptopurine to prevent recurrence of Crohn s disease following surgery. We will use the recurrence of symptoms as the primary outcome measure, with endoscopic examination of the relevant area and the need for further sugery as secondary outcome measures. If this trial were to show an effect of the drug we would anticipate a wide uptake and improved quality of life for patients with Crohn s disease following surgery.

This multi-centre double-blind randomised placebo-controlled trial will assess the value of 6-mercaptopurine in preventing recurrence of Crohn‘s disease in patients undergoing ileocolonic resection. The primary endpoint is clinical recurrence requiring rescue medical therapy. Secondary endpoints include further surgery. Clinical evaluation will occur every 4 months for 3 years. Colonoscopy at 12 and 36 months (or on relapse) will assess endoscopic evidence of disease recurrence. Faecal calprotectin will be assessed as a marker of early recurrence. TPMT and 6MP metabolite levels with assess the clinical utility of these assays. Genetic and serological data will form part of an exploratory prognostic model.