Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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5 January 2021 |
Main ID: |
ISRCTN66099597 |
Date of registration:
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27/02/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Clinical Officer Surgical Training in Africa (COST-Africa)
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Scientific title:
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Clinical Officer surgical training in Africa (COST-Africa): a cluster randomised controlled trial |
Date of first enrolment:
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01/04/2011 |
Target sample size:
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18 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN66099597 |
Study type:
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Interventional |
Study design:
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Cluster randomised controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Malawi
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Zambia
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Contacts
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Name:
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Ruairi
Brugha |
Address:
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Royal College of Surgeons in Ireland (RCSI)
123 St Stephens Green
2
Dublin
Ireland |
Telephone:
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+353 1 402 2764 |
Email:
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costafrica@rcsi.ie |
Affiliation:
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Name:
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Address:
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Telephone:
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Email:
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Key inclusion & exclusion criteria
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Inclusion criteria: District hospitals with the infrastructural capacity to delivery surgery
Exclusion criteria: Children under five years of age attending district hospitals
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diseases / conditions amenable to surgery Surgery
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Intervention(s)
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Random allocation of district hospitals to intervention and control arms within pairs of similar (matched) district hospitals in Malawi and Zambia.
1. Intervention arm: the selected clinical officers will be placed at treatment hospitals (8 in Malawi and 15 in Zambia) where they will perform general surgery, with periodic supervisory visits from trained surgeons.
2. Control arm: hospitals without trained clinical officers. The study will measure outcomes at different levels: the graduate clinical officers, the hospitals, surgical patients and their families. During the study period the control hospitals will continue with their normal patient care procedures.
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Primary Outcome(s)
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Increase in the types and volume (numbers) of general surgical procedures at the interventions hospitals
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Secondary Outcome(s)
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1 Improved competence of COs/MLs to undertake general surgery, measured in terms of enhancements in: 1.1. Their surgical skills 1.2. Clinical management of patients 1.3. Implementation of clinical best practice protocols 1.4. Health care of patients 2. Change in rates of referral for general surgical procedures. 3. Change in morbidity and mortality from surgical conditions, improved quality of life 4. Reduced expenditure, both for hospitals providing surgery and patients undergoing surgery 5. Cost effectiveness in delivering general surgery by COs/MLs at the district level
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Secondary ID(s)
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FP7-AFRICA-2010, no: 266417
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Source(s) of Monetary Support
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European Union (EU) - 7th Framework Programme for Research and Technological Development (FP7) Grant, Ref: FP7-AFRICA-2010, grant agreement no: 266417
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Ethics review
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Status:
Approval date:
Contact:
1. Research Ethics Committee of the Royal College of Surgeons in Ireland, 30th April 2012, ref: REC727
2. The University of Zambia Biomedical Research Ethics Committee, Zambia, 29th May 2012, ref: 018-03-12
3. University of Malawi, College of Medicine Research Ethics Committee (COMREC), Malawi, 31st July 2012, ref: P.03/12/1188.
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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30/03/2016 |
URL:
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