Abstract [eng] |
Background and Aims: Low anterior resection syndrome (LARS) commonly affects patients following rectal resection, impairing bowel function and quality of life. Transanal irrigation (TAI) has emerged as a potential intervention to alleviate these symptoms. This study aims to assess whether TAI provides superior improvements in bowel function and quality of life compared with the best supportive care in patients after low anterior resection. Method: A multicenter randomized clinical trial comparing TAI (intervention – starting with 500ml per day, increased to a maximum of 1L normal warm water once a day) with best supportive care (control – diet modification, antidiarrheal medication, biofeedback) was performed. Patients who have undergone low anterior resection in four European centers were included. The primary outcome was differences in bowel function at baseline, 3 months, 6 months, and 1 year, which were evaluated using LARS and Wexner scores. The secondary outcome was quality-of-life (QoL), measured by Measure Yourself Medical Outcome Profile (MYMOP) and Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (MSKCC BFI) questionnaires. Results: Forty patients were enrolled in the study (TAI 19, control 21). LARS scores were significantly better in the TAI group just after 3 months (median 4 versus 36 in the control group; p<0.001), after 6 months (median 3 versus 36; p<0.001), and stayed practically the same after 12 months (median 3 versus 36; p<0.001). Wexner scores were also lower in the TAI group after 3 months (median 0 versus 14 in the control group; p<0.001), 6 months (median 0 versus 14; p<0.001), and 12 months (median 0 versus 13; p<0.001). MYMOP score was lower in the TAI group after 3 months (median 2 versus 11; p<00001). In addition, patients in the TAI group also achieved higher MSKCC BFI scores after 3 months (median 89 versus 39 in the control group; p<0.001), after 6 months (median 89 versus 39; p<0.001), and after 12 months (median 89 versus 39; p<0.001). The average duration of the TAI procedure was 34.5 minutes. 2 patients in the TAI group experienced adverse reactions such as dizziness and tenesmus. 1 patient in the TAI group developed a late colonic fistula which required surgery. Conclusion: The study confirms that TAI leads to better functional outcomes and improvement in QoL compared with best supportive care. Further studies should be initiated to personalize the LARS treatment even more. |