BE1 Study Spain - CAPSULE SYSTEM FOR COLOSTOMATES
- Conditions
- Quality of Life of Colostomized Patient
- Registration Number
- NCT04239183
- Lead Sponsor
- B. Braun Medical SA
- Brief Summary
A comparative study on the improvement of quality of life of colostomized patients using the new Be1 device with capsule system.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
- Inclusion criteria groups 1 and 2
- Patients of at least 18 years of age.
- Recently operated patients with a descending colostomy.
- Patients with a non-retracted stoma measuring no more than 1.5 cm in height.
- Patients agreeing to participate in the study and who have signed the informed consent in accordance with the legal requirements.
- Patients who in the opinion of the stoma therapist are candidates for a two-piece mechanical device.
Inclusion criteria group 3
- Patients of at least 18 years of age.
- Patients with a descending colostomy for over 6 months and who carry a two-piece mechanical device.
- Patients with a non-retracted stoma measuring no more than 1.5 cm in height.
- Patients agreeing to participate in the study and who have signed the informed consent in accordance with the legal requirements
- Patients who in the opinion of the stoma therapist are candidates for use of the Be1 device with capsule system.
Exclusion criteria groups 1 and 2
- Patients with cognitive impairment which in the opinion of the investigator would not allow completion of the questionnaire or could pose problems.
- Patients who are participating in another study.
- Patients with multiple stomas.
- Vulnerable patients or subjects under legal tutelage.
- Patients with known allergy to any of the components of the study product.
- Patients with a retracted stoma.
- Patients with a prolapsed stoma or a stoma measuring more than 1.5 cm in height.
Exclusion criteria group 3
- Patients with cognitive impairment which in the opinion of the investigator would not allow completion of the questionnaire or could pose problems.
- Patients who are participating in another study.
- Patients with multiple stomas.
- Vulnerable patients or subjects under legal tutelage.
- Patients with known allergy to any of the components of the study product.
- Patients with a retracted stoma.
- Patients with a prolapsed stoma or a stoma measuring more than 1.5 cm in height.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method StomaQoL 1 month to demonstrate improvement of quality of life (difference of at least 5 points in the StomaQoL questionnaire) among descending colostomy patients
- Secondary Outcome Measures
Name Time Method Questionnaire 1 month Assessment of patient satisfaction with the new Be1 device with capsule system versus a current two-piece mechanical device.
Biota Analysis 1 month Demonstration that the new Be1 device with capsule system improves the microbiota of the colostomized patient