Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02564783 |
| Other study ID # |
VSKENDU-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 22, 2015 |
| Last updated |
October 26, 2015 |
| Start date |
October 2015 |
| Est. completion date |
October 2015 |
Study information
| Verified date |
October 2015 |
| Source |
Helsinki University Central Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Kenya: Institutional Review Board |
| Study type |
Observational
|
Clinical Trial Summary
PURPOSE OF THE STUDY
The main purpose of this study is to find out what is the true burden of surgical conditions
in pediatric population in a well defined geographical rural area in western Kenya.
Description:
MATERIAL This research will be conducted in the Homa Bay county in western Kenya in
previously selected locations around the county in rural area. An estimated 800 children and
youth under the age of 18 will be selected for this study. This study will take place
between October and November 2015. The investigators hypothesis, based on prior survey
studies done in Sub-Saharan Africa, is that roughly 6% of the people under 18 are suffering
from a surgical condition. In a sample size of 800 people the margin of error is 1,65%.
People who are currently being treated in a hospital will be excluded from the study. Also
the people who decline from the study will be excluded. The number of declinations will be
recorded.
METHODS The people will receive a written and a verbal information regarding the study and
its purposes from the primary research assistant. If they decide to participate in the study
they or their parent/guardian will be asked to sign an informed consent. Local interpreter
will be available to help with possible questions.
The primary research assistant will conduct a short interview. Prior medical history will be
taken. The participants will be asked their age. If age is not known the primary research
assistant will estimate it. The height, weight and sex will be registered. A full physical
examination will then be conducted. In this examination the participants will be assessed
for visible deformations i.e. masses, scars, limb deformities. It will be determined whether
the deformation is congenital or acquired. If the deformity is acquired the cause will be
asked from the subject. The range of major joints will be registered. In case of palpable
masses the possible diagnosis will be figured out using basic clinical skills. A structured
survey sheet will be used collect the information. No other forms of diagnostic measures
will be used. No blood or microbial culture samples will be collected and no x-ray imaging
will be done.
If a surgical condition is diagnosed the participant will be informed about the nature and
possible cause of this condition. No treatment procedures will be done on site.
