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 determine whether abdominoperineal resection has a better effect on the quality of life than sphincter preservation surgery at 3 years after surgery.

Methods: This prospective, cohort study included patients who underwent radical resection for low rectal cancer. The primary outcomes were European Organisation for Research and Treatment of Cancer 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. The study was registered with ClinicalTrials.gov (NCT01461525).

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. The global quality of life scores did not differ between sphincter preservation surgery and abdominoperineal resection groups (adjusted mean difference, 4•2 points on a 100-point scale; 95% confidence interval [CI], -1•3 to 9•7, p = 0•1316). Abdominoperineal resection was associated with a worse body image (9•8 points; 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). The 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: In this long-term prospective study, abdominoperineal resection failed to meet the superiority to sphincter preservation surgery in terms of quality of life. Although the global quality of life scores did not differ between groups, this study suggests that sphincter preservation surgery can be an acceptable alternative to abdominoperineal resection for low rectal cancer, offering a better quality of life and sexual-urinary functions, with no increased oncological risk even after 3 years.

Funding: Seoul National University Bundang Hospital, Korea.

Keywords: Abdominoperineal resection; Oncological outcome; Quality of life; Rectal cancer; Sexual function; Sphincter preservation surgery; Urinary function.

Fig. 1

Flow of participants in the ASPIRE study. *All participants enroled for treatment. The intention-to-treat population was the primary analysis set for all primary and secondary efficacy endpoints. ^†Patients who completed the study without any major protocol violations, including conversion to permanent stoma in the sphincter preservation surgery group. OA-ITT= observational analogues of intention-to-treat; OA-PP= observational analogues of per protocol.

Fig. 2

Sexual and urinary functions from baseline to 3 years after surgery. (A) Sexual function in men scored with IIEF-5; range of unadjusted mean scores: 5–25, with higher scores indicating better function; vertical lines show 95% CIs. (C) Sexual function in women scored with FSFI; range of unadjusted mean scores: 2–36, with higher scores indicating better function; vertical lines show 95% CIs. (E) Urinary symptom scored with IPSS; range of unadjusted mean scores: 0–35, with higher scores indicating worse symptom; vertical lines show 95% CIs. (B, D, F) *p < 0•05 in multivariable regression with linear GEEs at each time point, with adjustment for baseline values, age, sex, body mass index, pathological stage, tumour size, preoperative chemotherapy, operative time, morbidity, and approach. Positive values in B and D represent better function in the sphincter preservation surgery group, and negative values in F represent worse symptoms for the abdominoperineal resection group. IIEF-5=Five-item version of the International Index of Erectile Function; FSFI=Female Sexual Function Index; IPSS=International Prostate Symptom Score.

Fig. 3

Kaplan-Meier analyses of mortality. APR=abdominoperineal resection (reference); SPS=sphincter preservation surgery.