Randomised Controlled Trial to Evaluate a Direct Referral Service for Investigation of Patients with Low Risk Sympton Clusters Suggestive of Colorectal Cancer, as Against Usual Care

A randomised controlled trial was executed to compare three recognised outpatient investigation strategies for patients with gastrointestinal symptoms considered "low risk" for colorectal cancer. Over a one year period consenting patients referred to Lymington Hospital were randomised to one of three study arms: 'Colonoscopy', 'Flexible Sigmoidoscopy & Barium Enema', and 'Usual Care'. A novel endpoint was defined as the day on which the patient was informed of diagnosis, discharged with reassurance, or the need to further investigate. Measurements were taken in terms of time, number and nature of all appointments and visits; and patient satisfaction assessed by a purpose developed patient satisfaction questionnaire validated during the execution of the study. 111 patients were recruited of which 95 (85.5%) reached end point; 91 of these patients (95.8%) returned a completed questionnaire. There was no significant difference between the three study arms in terms of days to endpoint, nor in expressed patient satisfaction. The number of attendances required to reach endpoint was statistically fewer for the 'colonoscopy' arm; the cost of investigation to the NHS was also lower for this group. Patients in the 'Colonoscopy' arm did, however, have to wait longer for a first hospital appointment; a colonoscopy appointment was also the most likely to be cancelled. Survival analysis demonstrated a weighting towards the 'Usual Care' arm at the upper limit of patient experience (in terms of time to endpoint). Patients experiencing an unusually long wait were responsible for cancelling one or more appointments. The study supports the use of colonoscopy as a method of direct investigation: it is cheaper, requires less hospital visits, and attains a high level of satisfaction despite its shortcomings.