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Randomized Controlled Trial
. 2023 Jan 1;277(1):30-37.
doi: 10.1097/SLA.0000000000005482. Epub 2022 Jul 7.

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  1   2 , Charlotta M Bergström  3   4 , Caroline A M Nordenvall  2   5 , Karin S Westberg  2   3 , Asif M Johar  2 , Susanne F Tumlin Ekelund  1   6 , Kristina R Larsson  2 , Klas J Pekkari  3   7 , Gabriella C Jansson Palmer  2   5 , Pernilla Lagergren  2   8 , Mirna Abraham-Nordling  2   5
Affiliations
Randomized Controlled Trial

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 et al. Ann Surg. .

Abstract

Objective: The aim of the study was to evaluate transanal irrigation (TAI) as a treatment for low anterior resection syndrome (LARS).

Background: LARS 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 methods: A 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.

Results: A 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.

Conclusions: The results confirm our clinical experience that TAI reduces symptoms included in LARS and improves QoL.

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Conflict of interest statement

C.M.B. has been compensated by Coloplast (around €500) for a lecture in 2018 and he was a member of Coloplast’s Bowel Advisory board between 2016 and 2019 (compensated with around €1000 in total). The remaining authors report no conflicts of interest.

References

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    1. Pieniowski EHA, Nordenvall C, Palmer G, et al. Prevalence of low anterior resection syndrome and impact on quality of life after rectal cancer surgery: population-based study. BJS Open. 2020;4:935–942.
    1. Bryant CL, Lunniss PJ, Knowles CH, et al. Anterior resection syndrome. Lancet Oncol. 2012;13:e403–e408.
    1. Bregendahl S, Emmertsen KJ, Lous J, et al. Bowel dysfunction after low anterior resection with and without neoadjuvant therapy for rectal cancer: a population-based cross-sectional study. Colorectal Dis. 2013;15:1130–1139.
    1. Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012;255:922–928.

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