The Burden of Pediatric Surgical Conditions in Rural Kenya
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|ClinicalTrials.gov Identifier: NCT02564783|
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : October 27, 2015
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.
|Condition or disease||Intervention/treatment|
|Burden of Surgical Disease in Western Kenya||Other: No intervention|
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.
|Study Type :||Observational|
|Actual Enrollment :||800 participants|
|Official Title:||The Burden of Pediatric Surgical Conditions in Rural Kenya - a Prospective Cohort Study|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
- Other: No intervention
- Prevalence of surgical conditions in population under 18 in rural Western Kenya [ Time Frame: 25days (October 5th - October 30th 2015) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564783
|Homa Bay County School District|
|Homa Bay County, Kenya|
|Study Director:||Erkki Tukiainen, Professor||Helsinki University Hospital, Department of Plastic Surgery|