Quality of Life of Colostomized Patient Clinical Trial
Official title:
BE1 Study Spain - CAPSULE SYSTEM FOR COLOSTOMATES
A comparative study on the improvement of quality of life of colostomized patients using the new Be1 device with capsule system.
The primary objective is to demonstrate improvement of quality of life (difference of at
least 5 points in the StomaQoL questionnaire) among descending colostomy patients,
establishing the following comparisons:
1. Patients with recent surgery who after one month using a current two-piece mechanical
device switch to the new Be1 device with capsule system versus patients who after one
month continue to use the same current two-piece mechanical device during four months.
2. Patients who have been using a current two-piece mechanical device during more than 6
months after an ostomy and agree to switch to the new Be1 device with capsule system
during four months.
The following secondary objectives have been defined:
- Assessment of patient satisfaction with the new Be1 device with capsule system versus a
current two-piece mechanical device.
- Demonstration that the new Be1 device with capsule system improves the microbiota of the
colostomized patient.
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