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Impact of a Patient-Centered Program for Low Anterior Resection Syndrome: A Multicenter, Single-Blinded, Randomized Controlled Trial
*Richard Garfinkle¹, *Marie Demian¹, *Sarah Sabboobeh¹, *Sahir Bhatnagar¹, *Julie Savard¹, *Sebastien Drolet⁶, *Sender Liberman³, *Carl Brown⁴, *Jason Park⁵, *Joengyoon Moon¹, *Carmen Loiselle⁷, Steven D. Wexner², Liliana Bordeianou⁸, *Gabriela Ghitulescu¹, *Julio Faria¹, *Nancy Morin¹, *Carol-Ann Vasilevsky¹, *Marylise Boutros^2
1Colon and Rectal Surgery, Jewish General Hospital, Montreal, QC, Canada; ²Colorectal Surgery, Cleveland Clinic Florida, Weston, FL; ³Surgery, McGill University Health Center, Montreal, QC, Canada; ⁴Surgery, St. Paul's Hospital, Vancouver, BC, Canada; ⁵Surgery, Vancouver General Hospital, Vancouver, BC, Canada; ⁶Surgery, CHU de Quebec, Quebec City, QC, Canada; ⁷Oncology and Ingram School of Nursing, McGill University, Montreal, QC, Canada; ⁸Colorectal Surgery, Massachusetts General Hospital, Boston, MA

Objective(s): Low Anterior Resection Syndrome (LARS), defined as disordered bowel function after restorative proctectomy, affects most rectal cancer patients and has a negative effect on quality of life (QoL). 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. The objective of this study was to evaluate the impact of a LARS Patient-Centered Program (LARS-PCP) – an informational and guided self-management intervention – on global QoL after surgery in comparison to standard care. Methods: This was a multicenter, assessor-blinded, parallel-groups, pragmatic randomized controlled trial (NCT03828318). Adult patients who had undergone a restorative proctectomy with a diverting ostomy and who were scheduled for ostomy closure were recruited from one of five academic centers. Consecutive participants were randomized (using block and stratified randomization) in a 1:1 ratio into one of two arms: LARS-PCP or Standard Care. The LARS-PCP consisted of an informational tool (booklet and bowel, nutrition and medication diaries) and nursing support centralized from one institution. Participants in the Standard Care arm received usual care for LARS available at their institution. Outcomes were measured with the use of patient-reported outcomes measures at various timepoints over the 12-month follow-up period (Figure 1). The primary outcome was global QoL (measured using the EORTC-QLQ-C30) at 6-months following ostomy closure. Forty-five participants were required in each arm to detect a 10-point difference in QoL (recommended effect size for interventions aimed at improving QoL). The treatment effect of the LARS-PCP on global QoL was modeled using generalized estimating equations (GEE). Results: Between January 2020 and December 2022, 160 patients were randomized: 78 to the LARS-PCP and 82 to Standard Care (Figure 2). Participant demographics, disease characteristics and surgical details were similar between LARS-PCP and Standard Care participants. LARS-PCP participants had an average of 7.2 telephone/video nurse calls and most (90.7%) used the informational tool. At 6 months following ostomy closure, LARS-PCP was associated with a higher mean global QoL (79.7 ±8.7 vs. 67.8 ±9.5, p=0.001; GEE model b=14 (95% CI 6 to 23, p=0.001)). This association was maintained at 12-month follow-up (82.0 ±9.1 vs. 74.9 ±10.1, p=0.036; GEE model b=9 (95% CI 2 to 17, p=0.016)). Role functioning also improved among LARS-PCP participants; all other functional scales were similar. 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. Conclusions: This was the first multicenter randomized controlled trial to demonstrate that nurse-guided LARS self-management improved QoL after restorative proctectomy.
Figure 1. Study schedule for LARS-PCP participants