Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202009725910988 Date of Registration: 16/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title An Evaluation of Surgical Headlights in Sierra Leone
Official scientific title An Evaluation of Surgical Headlights in Sierra Leone
Brief summary describing the background and objectives of the trial We evaluated two surgical headlights in a district hospital in Sierra Leone. A mixed methods approach was adopted, comparing the technical specifications and usability of the headlights using in theatre observations and a questionnaire. Focus group discussions, involving theatre staff and hospital managers, were used to explore a range of challenges from electricity supply to infrastructure availability.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 18/05/2018
Actual trial start date 18/05/2018
Anticipated date of last follow up 13/06/2018
Actual Last follow-up date 13/06/2018
Anticipated target sample size (number of participants) 25
Actual target sample size (number of participants) 24
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Use of surgical Headlights for the length of the operation - average 2 hours in addition to overhead operating theater lights we gave surgical headlightss to the surgeons to see if it improved their view of the operating field and how this compared to the use of just the overheadlights 16
Control Group standard operation without a surgical headlight lenght of operation, approx 2 hours no intervention, observation of surgical lighting without a headlight 8 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
anyone having a surgical operation at the distrcit hospital who gave prior informed consent anyone having an urgent emergency operation who was unable to give prior infomred consent Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/05/2018 Sierra Leone ethics and scientific review committee
Ethics Committee Address
Street address City Postal code Country
5th floor, youyi building brokfields, freetown sierra leone Freetown 000000 Sierra Leone
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/05/2018 Leeds Institute of Health Sciences Research Ethics SubCommittee
Ethics Committee Address
Street address City Postal code Country
01 The University of Leeds, Leeds Leeds 00000 United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome suergeons were given a survey soconsisting of likert scales to assess quality of the device quality and useability. surgeons found the headlights helpful and would like to use them again, one headlight was generally prefered due to the mounting weight and the improved visual field just after the operation
Secondary Outcome focus groups were set up recorded and transcribed, with thematic analysis generated to assess barriers to adequate lighting of the surgical field in the rural district hosital before the operations took place
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Masanga hospital Masanga hospital, masanga Masanga Sierra Leone
FUNDING SOURCES
Name of source Street address City Postal code Country
royal college of surgeons of england 35, Lincolns Inn Fields, Holborn London 002300 United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor th university of leeds the university of leeds, Woodhouse, Leeds Leeds United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator David Kemball davidkemball@doctors.org.uk +447503726051 Surgery, Gastroenterology, Leeds Institute of Medical Research, St. James, University of Leeds,
City Postal code Country Position/Affiliation
Leeds United Kingdom Medical student
Role Name Email Phone Street address
Public Enquiries David Kemball davidkemball@doctors.org.uk +447503726051 Surgery, Gastroenterology, Leeds Institute of Medical Research, St. James, University of Leeds,
City Postal code Country Position/Affiliation
Leeds United Kingdom medical student
Role Name Email Phone Street address
Scientific Enquiries William Bolton W.S.Bolton@leeds.ac.uk +447803336202 Surgery Gastroenterology, Leeds Institute of Medical Research, St. James, University of Leeds,
City Postal code Country Position/Affiliation
leeds United Kingdom research fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD No: There is not a plan to make IPD available. Clinical Study Report N/A N/A
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information