Impact of a Patient-centered Program for Low Anterior Resection Syndrome: A Multicenter, Single-blinded, Randomized Controlled Trial.

Abstract

The objective of this study was to evaluate the impact of a low anterior resection syndrome (LARS) patient-centered program (LARS-PCP)-an informational and guided self-management intervention-on global quality of life (QoL) after surgery in comparison to standard care. Self-management using conservative measures is the cornerstone of LARS treatment; however, due to the individual and symptom-based nature of LARS, self-management largely consists of unguided troubleshooting with minimal success. Adult patients who had undergone a restorative proctectomy with a diverting ostomy and who were scheduled for ostomy closure were randomized in a 1:1 ratio into 1 of 2 arms: LARS-PCP or standard care. The LARS-PCP consisted of an informational tool and nursing support centralized from one institution. Outcomes were measured with the use of patient-reported outcomes measures at various timepoints over the 12-month follow-up period. The primary outcome was global QoL at 6 months after ostomy closure. In total, 160 patients were randomized: 78 to the LARS-PCP and 82 to standard care. At 6 months after ostomy closure, LARS-PCP was associated with a higher mean global QoL (79.7 ±8.7 vs. 67.8 ±9.5, P= 0.001). This association was maintained at 12-month follow-up (82.0 ±9.1 vs. 74.9 ±10.1, P= 0.036). The incidence of major LARS was lower at 1-month (60.0% vs. 81.7%, P =0.008) postoperatively among LARS-PCP participants but was similar at 3, 6, and 12 months. This was the first multicenter randomized controlled trial to demonstrate that nurse-guided LARS self-management improved QoL after restorative proctectomy.