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Randomized Controlled Trial Multicenter Study
A Randomized Controlled Clinical Trial of Transanal Irrigation Versus Conservative Treatment in Patients With Low Anterior Resection Syndrome After Rectal Cancer Surgery.
- Emil H A Pieniowski, Charlotta M Bergström, Caroline A M Nordenvall, Karin S Westberg, Asif M Johar, Susanne F Tumlin Ekelund, Kristina R Larsson, Klas J Pekkari, Gabriella C Jansson Palmer, Pernilla Lagergren, and Mirna Abraham-Nordling.
- Department of Surgery, South General Hospital (Södersjukhuset), Stockholm, Sweden.
- Ann. Surg. 2023 Jan 1; 277 (1): 303730-37.
ObjectiveThe aim of the study was to evaluate transanal irrigation (TAI) as a treatment for low anterior resection syndrome (LARS).BackgroundLARS is a bowel disorder that is common after sphincter preserving rectal cancer surgery. Despite symptomatic medical treatment of LARS many patients still experience bowel symptoms that may have a negative impact on quality of life (QoL). TAI is a treatment strategy, of which the clinical experience is promising but scientific evidence is limited.Materials And MethodsA multicenter randomized trial comparing TAI (intervention) with conservative treatment (control) was performed. Inclusion criteria were major LARS, age above 18 years, low anterior resection with anastomosis and a defunctioning stoma as primary surgery, >6 months since stoma reversal, anastomosis without signs of leakage or stricture, and no signs of recurrence at 1-year follow-up. The primary endpoint was differences in bowel function at 12-month follow-up measured by LARS score, Cleveland Clinic Florida Fecal Incontinence Score, and 4 study-specific questions. The secondary outcome was QoL.ResultsA total of 45 patients were included, 22 in the TAI group and 23 in the control group. Follow-up was available for 16 and 22 patients, respectively. At 12 months, patients in the TAI group reported significantly lower LARS scores (22.9 vs 32.4; P =0.002) and Cleveland Clinic Florida Fecal Incontinence Score (6.4 vs 9.2; P =0.050). In addition, patients in the TAI group also scored significantly higher QoL [8 of 16 European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) QoL aspects] compared with the control group.ConclusionsThe results confirm our clinical experience that TAI reduces symptoms included in LARS and improves QoL.Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.
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