Algorithm-based management of patients with gastrointestinal symptoms in patients after pelvic radiation treatment (ORBIT): a randomised controlled trial

摘要

Background Chronic gastrointestinal symptoms after pelvic radiotherapy are common, multifactorial in cause, and affect patients' quality of life. We assessed whether such patients could be helped if a practitioner followed an investigative and management algorithm, and whether outcomes differed by whether a nurse or a gastroenterologist led this algorithm-based care.Methods For this three-arm randomised controlled trial we recruited patients (aged >18 years) from clinics in London, UK, with new-onset gastrointestinal symptoms persisting 6 months after pelvic radiotherapy. Using a computer-generated randomisation sequence, we randomly allocated patients to one of three groups (1:1:1; stratified by tumour site [urological, gynaecological, or gastrointestinal], and degree of bowel dysfunction [IBDQ-B score <60 vs 60-70]): usual care (a detailed self-help booklet), gastroenterologist-led algorithm-based treatment, or nurse-led algorithm-based treatment. The primary endpoint was change in Inflammatory Bowel Disease Questionnaire-Bowel subset score (IBDQ-B) at 6 months, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00737230.