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Randomized Controlled Trial
. 2025 Sep 1;282(3):361-370.
doi: 10.1097/SLA.0000000000006777. Epub 2025 Jun 12.

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

Richard Garfinkle  1 , Marie Demian  1 , Sarah Sabboobeh  1 , Sahir Bhatnagar  1 , Julie Savard  1 , Sebastien Drolet  2 , Sender A Liberman  3 , Carl J Brown  4 , Jason Park  5 , Jeongyoon Moon  1 , Carmen G Loiselle  6 , Steven D Wexner  7 , Liliana Bordeianou  8 , Gabriela Ghitulescu  1 , Julio Faria  1 , Nancy Morin  1 , Carol-Ann Vasilevsky  1 , Marylise Boutros  1   3   7
Affiliations
Randomized Controlled Trial

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

Richard Garfinkle et al. Ann Surg. .

Abstract

Objective: 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.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: This was the first multicenter randomized controlled trial to demonstrate that nurse-guided LARS self-management improved QoL after restorative proctectomy.

Keywords: low anterior resection syndrome; management; rectal cancer; surgery.

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References

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