Quality of Life of Colostomized Patient
Conditions
Keywords
stomy, stomatherapy, colestomy
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.
Interventions
DEVICEStomatherapy
Demonstrate improvement of quality of life (difference of at least 5 points in the StomaQoL questionnaire (21)) among descending colostomy patients, establishing the following comparisons.
Sponsors
B. Braun Medical SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactMM
Outcome results
None listed