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

Lancet. 2013 Dec 21;382(9910):2084-92. doi: 10.1016/S0140-6736(13)61648-7. Epub 2013 Sep 23.


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, number NCT00737230.

Findings: Between Nov 26, 2007, and Dec 12, 2011, we enrolled and randomly allocated 218 patients to treatment: 80 to the nurse group, 70 to the gastroenterologist group, and 68 to the booklet group (figure). Most had a baseline IBDQ-B score indicating moderate-to-severe symptoms. We recorded the following pair-wise mean difference in change in IBDQ-B score between groups: nurse versus booklet 4·12 (95% CI 0·04-8·19; p=0·04), gastroenterologist versus booklet 5·47 (1·14-9·81; p=0·01). Outcomes in the nurse group were not inferior to outcomes in the gastroenterologist group (mean difference 1·36, one sided 95% CI -1·48).

Interpretation: Patients given targeted intervention following a detailed clinical algorithm had better improvements in radiotherapy-induced gastrointestinal symptoms than did patients given usual care. Our findings suggest that, for most patients, this algorithm-based care can be given by a trained nurse.

Funding: The National Institute for Health Research.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Algorithms
  • Female
  • Gastroenterology*
  • Gastrointestinal Tract / radiation effects*
  • Humans
  • Inflammatory Bowel Diseases / etiology
  • Inflammatory Bowel Diseases / nursing*
  • Male
  • Middle Aged
  • Pamphlets
  • Pelvic Neoplasms / radiotherapy*
  • Quality of Life
  • Radiation Injuries / etiology
  • Radiation Injuries / nursing*
  • Radiotherapy / adverse effects
  • Treatment Outcome

Associated data