Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT04586634
Brief Summary:
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 ≥ 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:
• 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
Study:
NCT04586634
Study Brief:
Protocol Section:
NCT04586634