The Burden of Pediatric Surgical Conditions in Rural Kenya

The Burden of Pediatric Surgical Conditions in Rural Kenya - a Prospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Burden of Surgical Disease in Western Kenya
• Intervention / Treatment: Other: No intervention

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
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• Kenya
  • Homa Bay County, Kenya
    • Homa Bay County School District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of surgical conditions in population under 18 in rural Western Kenya	25days (October 5th - October 30th 2015)

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Study Director: Erkki Tukiainen, Professor, Helsinki University Hospital, Department of Plastic Surgery

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 22, 2015
• First Submitted That Met QC Criteria: September 29, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Estimate): October 27, 2015
• Last Update Submitted That Met QC Criteria: October 26, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: VSKENDU-1