N/A
N=121
The Nordic Consensus Study
Stoma Site Leakage · Quality of Life · Nurse's Role · Stoma Ileostomy · Colostomy Stoma
Bottom Line
View on ClinicalTrials.gov: NCT04763863 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Evaluate Body Assessment Tool Based on the Nurse Evaluation Form — 4.6; 5.1; 4.7 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Body Assessment Tool (Other); Clinical usability evaluation of the Body Assessment Tool (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate Body Assessment Tool Based on the Nurse Evaluation Form |
4.6; 5.1; 4.7 | — |
| SECONDARY QoL (Based on the Three OLI Domain Scores (Emotional Impact, Usual and Social Activities, and Coping and in Control) |
62.1; 80.0; 78.5; 89.2; 67.3; 83.5 | — |
Summary
A Body Assessment Tool was developed to provide nurses with a more structured approach when choosing ostomy products. The Body Assessment Tool will to be evaluated in clinical settings.
Eligibility Criteria
Inclusion Criteria
- Ostomates
- Male or female ≥18years
- Leakage issues
Exclusion Criteria
- Requires a caretaker or is unable to participate in the study
- Is pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT04763863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.