About this trial
The goal of this observational study is to test the questionnaire CLEFT-Q in a population of patients with cleft lip and/or palate. The main questions it aims to answer are:
1. Are CLEFT-Q scores reliable over time? 2. Can CLEFT-Q detect change following surgical treatment intervention? 3. What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate? 4. What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate? 5. Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention? 6. What are the main expectations that patients express before a surgical intervention? 7. How do patients perceive that the results after surgical interventions meet their expectations? 8. Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q? 9. How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes?
Participants will
1. Fill out the questionnaire CLEFT-Q twice with a two-week space. 2. Before and 1 year after an operation. 3. Be interviewed about their experiences related to an operation or using CLEFT-Q.
Researchers will compare results from the cleft lip and palate population to see if there is a difference between them and a population without cleft lip and palate.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Cleft lip and/or palate
Planned secondary surgery of the nose, lips, jaw or to improve speech
Can speak and read Swedish
Disqualifiers
Multiple surgeries at once
Trial population
\- Patients with cleft lip and/or palate who have been operated as infants and opt for secondary surgery to improve appearance, occlusion or speech.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
6
Trial groupsSee each trial group below.
Trial outcomes
Primary outcomes
CLEFT-Q change scores
CLEFT-Q is a questionnaire on health related quality of life specific to patients with cleft lip and palate
Secondary outcomes
Photograph
Photographs from before and after surgery
Speech
Recording of speech
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Department of Plastic and Reconstructive Surgery
Lead sponsor
Karolinska University Hospital
Collaborator
Linköping Univeristy Hospital
Collaborator
University Hospital, Umeå
Collaborator
Uppsala University Hospital
Collaborator