Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation. A Randomized Cross Over Study.
Patients will undergo anal physiological assessment and will then be randomized to either
treatment arm. The first 12 weeks they will be optimized in the conservative treatment of
their bowel function before beginning active treatment with TAI or PNE. After 8 and 4 weeks
respectively, the treatment will stop and they will have a period of 4 weeks back on
optimized conservative treatment before beginning active treatment in the other active arm.
Detailed records of bowel, micturition and sexual function and QoL will be obtained at
regular intervals during the entire trial fase.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
changes in LARS score
A symptom score ranging from 0 to 42 points calculated on the basis of bowel function
baseline, 12, 16, 20, 24 and 28 weeks
Katrine J. Emmertsen, MD
University of Aarhus
Denmark: The Regional Committee on Biomedical Research Ethics