Objective The primary objective is to demonstrate superiority of the Peristeen cone catheter compared to standard of care. The secondary objective is to investigate quality of life and different benefits and aspects of treatment and satisfaction with the Peristeen cone catheter. Design of the investigation This is a randomised, open-label, parallel investigation comparing the Peristeen cone catheter with standard of care in subjects with major LARS (LARS score ā„ 30). Each subject will be enrolled for a study duration of 12 weeks. Subjects will be randomized to the treatments stratified by neo-adjuvant radiotherapy. The comparator in this study will be current standard of care for patients with LARS which is conservative bowel management. This is defined as: Supportive therapy according to the individual treatment protocols available at each participating site. Primary endpoint and secondary endpoints Primary endpoint: ā¢ LARS score, obtained from the LARS score questionnaire\* Secondary endpoints: * Number of subjects with Major LARS\* * FIQL Score - scale 1, Modified American Society for Colorectal Surgeons Questionnaire\* * FIQL Score - scale 2, Modified American Society for Colorectal Surgeons Questionnaire\* * FIQL Score - scale 3, Modified American Society for Colorectal Surgeons Questionnaire\* * FIQL Score - scale 4, Modified American Society for Colorectal Surgeons Questionnaire\* * EQ-5D-5L - utility score\* * EQ-5D-5L - VAS score (scale 0-10 cm)\* * Satisfaction with treatment (scale 0-10 cm)\* * Number of adverse events\* \*All endpoints are measured per subject at study completion
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LARS Score
Timeframe: Total score measured per subject at study completion after 12 weeks