Transanal irrigation for low anterior resection syndrome treatment: international multicentre randomized clinical...

Long-term bowel dysfunction can impact a significant proportion of patients following anterior resection. The aim of this study was to assess the efficacy of transanal irrigation (TAI) to treat low anterior resection syndrome.

Adults (≥ 18 years) with major low anterior resection syndrome (score > 30) at least 12 months after low anterior resection were enrolled at four European centres. Eligible patients were randomized 1 : 1 using block randomization to the TAI group or best supportive care group. The primary endpoint was the feasibility of TAI measured by treatment adherence or switch of therapy. Secondary endpoints included bowel function, quality of life and study-specific patient satisfaction questions. Outcome evaluators and the statistical team were blinded to allocation, whereas participants and caregivers were unblinded.

Forty-one patients were randomized, of which 40 (19 TAI; 21 best supportive care) completed follow-up; 1 patient in the TAI group was excluded due to fistula surgery. At 12 months, low anterior resection syndrome (median 3 (range 0-39) versus 36 (2-42); P < 0.001) and Wexner scores (median 0 (0-15) versus 13 (4-20); P < 0.001) were significantly lower in the TAI group compared with the control group. The Measure Yourself Medical Outcome Profile score was lower in the TAI group after 3 months (median 2 (0-11) versus 11 (7-12); P < 0.001). In addition, patients in the TAI group achieved higher Memorial Sloan Kettering Cancer Center Bowel Function Instrument scores after 12 months (median 89 (37-90) versus 39 (28-61); P < 0.001). Adherence was high, with 15 (75%) maintaining daily irrigation, and patient satisfaction measures favoured TAI. Two mild procedure-related adverse events (tenesmus, dizziness) were reported.

This randomized clinical feasibility study confirms that TAI is feasible and has high acceptability for patients. It leads to better functional outcomes and improvements in quality of life compared with the best supportive care for patients with low anterior resection syndrome.

NCT05920681 (http://www.clinicaltrials.gov).