Goals of work: Health-related quality of life (HRQL) is an important outcome after surgery for colorectal cancer (CRC), and accurate assessment is required to fully inform clinical decision making. The purpose of this review is to summarise randomised surgical trials in CRC with robust HRQL to consider the role of HRQL in surgical decision making.
Materials and methods: A systematic review in Medline and the Cochrane Controlled Trials Register identified randomised surgical trials with HRQL. HRQL assessment was categorised as robust according to predefined criteria, and the clinical implications of HRQL were considered.
Main results: One hundred seventy-seven articles were identified, and a detailed review reduced this to eight trials. Four compared laparoscopic with open surgery, and four evaluated coloanal anastomotic techniques. The most commonly used HRQL instrument was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30, and HRQL was usually a secondary outcome measure. In four (50%) trials, HRQL assessment was categorised as methodologically robust, although only two trials had sample size calculations based upon a HRQL endpoint. Six trials based the final treatment recommendation in the context of the HRQL outcomes.
Conclusion: In randomised surgical trials in CRC, HRQL assessment informs clinical decision making, and future trials require robust assessment of relevant patient-reported outcomes.