Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Burden of Pediatric Surgical Conditions in Rural Kenya

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02564783
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):
Veikko Schepel, Helsinki University Central Hospital

Tracking Information
First Submitted Date September 22, 2015
First Posted Date October 1, 2015
Last Update Posted Date October 27, 2015
Study Start Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 29, 2015)
Prevalence of surgical conditions in population under 18 in rural Western Kenya [ Time Frame: 25days (October 5th - October 30th 2015) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Burden of Pediatric Surgical Conditions in Rural Kenya
Official Title The Burden of Pediatric Surgical Conditions in Rural Kenya - a Prospective Cohort Study
Brief 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.

Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 800 children and youth under the age of 18 in a well defined area in rural Western Kenya (Kabondo city in Homa Bay County).
Condition Burden of Surgical Disease in Western Kenya
Intervention Other: No intervention
No intervention
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 29, 2015)
800
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age under 18

Exclusion Criteria:

  • Not meeting the age criteria.
  • Declining to participate in the study.
  • Patients who meet the criteria but are currently being treated in a hospital.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Kenya
Removed Location Countries  
 
Administrative Information
NCT Number NCT02564783
Other Study ID Numbers VSKENDU-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Veikko Schepel, Helsinki University Central Hospital
Study Sponsor Helsinki University Central Hospital
Collaborators Not Provided
Investigators
Study Director: Erkki Tukiainen, Professor Helsinki University Hospital, Department of Plastic Surgery
PRS Account Helsinki University Central Hospital
Verification Date October 2015