Quality of Life after Sphincter Preservation Surgery or Abdominoperineal Resection for Low Rectal Cancer (ASPIRE): A Long-Term Prospective, Multicentre, Cohort Study

Abstract

Background: The long-term effects of radical resection on quality of life may influence the treatment selection. The objective of this study was to compare the quality of life after sphincter preservation surgery or abdominoperineal resection for low rectal cancer. Methods: This prospective, cohort study included patients who underwent radical resection for low rectal cancer. The primary outcomes were EORTC QLQ-C30 and CR38 quality-of-life scores 3 years after surgery, which were compared with linear generalised estimating equations, after adjustment for baseline values, a time effect, and an interaction effect between time and treatment. The secondary outcomes included sexual-urinary functions and oncological outcomes. Findings: Between December 2011 and August 2016, 342 patients were enrolled: 268 (78·4%) underwent sphincter preservation surgery and 74 (21·6%) underwent abdominoperineal resection. After 3 years, abdominoperineal resection was associated with a worse body image (adjusted mean difference, 9·8 points on a 100-point scale; 95% CI, 2·9 to 16·6, p=0·0052), micturition symptoms (-8·0 points; 95% CI, -14·1 to -1·8, p=0·0108), male sexual problems (-19·9 points; 95% CI, -33·1 to -6·7, p=0·0032), less confidence in getting and maintaining an erection in males (0·5 points on a 5-point scale; 95% CI, 0·1 to 0·8, p=0·0155), and worse urinary symptoms (-5·4 points on a 35-point scale; 95% CI, -8·0 to -2·7, p<0·0001). 5-year overall survival was worse with abdominoperineal resection in unadjusted (92·2% vs 80·9%; difference 11·3%, hazard ratio 2·38; 95% CI, 1·27 to 4·46, p=0·0052), but did not differ after adjustment. Interpretation: Sphincter preservation surgery for low rectal cancer provides a better quality of life and sexual-urinary functions after 3 years than abdominoperineal resection, confirming that abdominoperineal resection is limited in terms of its quality of life benefit, although it may be needed for oncologic safety in patients with advanced rectal cancer. Trial Registration: The study was registered with ClinicalTrials.gov under ID number NCT01461525. Funding Statement: Seoul National University Bundang Hospital, Korea Declaration of Interests: The authors declare that they have no conflicts of interest. Ethics Approval Statement: ASPIRE was a prospective, non-randomised study approved by the Institutional Review Boards of six clinical recruiting sites, which are listed together with the study protocol and the statistical analysis plan in Supplement 1.