Condition category
Surgery
Date applied
11/10/2019
Date assigned
15/10/2019
Last edited
12/11/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The need for surgical procedures is increasing, especially in developing countries where there is generally more need than availability. Research on the need for different types of surgery is needed to raise awareness of the medical need of people in these countries, to convince donors of the number of people with conditions that can be treated using surgery and to provide policy makers with the data needed to plan interventions. This study aims to investigate the need for surgery in Sierra Leone.
The researchers will conduct a survey on the numbers and types of surgeries needed across Sierra Leone. There are six parts to the study. The first is to repeat the Surgeon Over Seas Surgical Assessment Survey (SOSAS) from 2012, which was piloted in Sierra Leone. The original SOSAS study has already been performed in several other African and Asian countries, but has never been conducted twice in the same country. This will help us to see the differences in 7 years’ time. Secondly, they aim to under stand how common lower urinary tract symptoms (LUTS) are among men and boys aged 12 years or older, including an evaluation of health-seeking behaviour (what people do to try to resolve their symptoms). In addition, the researchers aim to study groin hernia and associated health-seeking behaviour and wounds and associated health-seeking behaviour. The survey will also investigate the need for surgeries related to women's health and childbirth, including comparing the health of mothers and newborns before, during and after the Ebola outbreak in Sierra Leone. Lastly, the researchers aim to investigate the numbers of surgical procedures performed per year and understand whether the proportion performed under the country's health service or paid for privately.

Who can participate?
Any person living in a household in the areas of Sierra Leone selected for the survey.

What does the study involve?
The researchers will go to randomly selected areas of the country and will visit people in their homes. They will conduct interviews with a representative of the household and two people from the household who have been selected randomly by rolling a dice. Depending on whether the selected people are in certain groups (for example, boys or men aged over 12 years), they might be asked additional questions from the survey.

What are the possible benefits and risks of participating?
There is no treatment in this study. It only involves interviews and limited physical examinations, therefore there are no risks expected. People will be asked questions about times when they have been unwell and some people might find this distressing.
Benefits will be mostly long-term. The information gathered will help to improve access to surgical treatment in Sierra Leone.

Where is the study run from?
Masanga Medical Research Unit (Sierra Leone)

When is the study starting and how long is it expected to run for?
September 2018 to December 2019

Who is funding the study?
CapaCare (Norway), Masanga Medical Research Unit (Sierra Leone) and Statistics Sierra Leone (Sierra Leone)

Who is the main contact?
1. Dr Håkon Bolkan, hakon.a.bolkan@ntnu.no
2. Professor Osman Sankoh, osman.sankoh@statistics.sl
3. Professor Martin Peter Grobusch, m.p.grobusch@amc.uva.nl


Trial website

Contact information

Type

Scientific

Primary contact

Dr Håkon Bolkan

ORCID ID

http://orcid.org/0000-0002-9609-4093

Contact details

Norwegian University of Science and Technology (NTNU)
Institute of Clinical and Molecular Medicine
Post Box 8905
Trondheim
N-7491
Norway
-
hakon.a.bolkan@ntnu.no

Type

Scientific

Additional contact

Prof Osman Sankoh

ORCID ID

Contact details

Statistician General
Statistics Sierra Leone (Stats SL)
Tower Hill
Freetown
-
Sierra Leone
+232 79 212761
osman.sankoh@statistics.sl

Type

Scientific

Additional contact

Prof Martin Peter Grobusch

ORCID ID

Contact details

Center for Tropical Medicine and Travel Medicine
Department of Infectious Diseases
Division of Internal Medicine
Amsterdam University Medical Centers
University of Amsterdam
Meibergdreef 9
PO Box 22660
Amsterdam
1100 DD
Netherlands
+31 20 566 2097
m.p.grobusch@amc.uva.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PRESSCO-SL

Study information

Scientific title

Prevalence Study on Surgical Conditions 2019 in Sierra Leone: PRESSCO-SL.

Acronym

PRESSCO-SL 2019

Study hypothesis

The need for surgical care is increasing, particularly in low- and lower middle-income countries where the burden of surgical conditions by far outweighs its treatment capacity. Knowledge on the prevalence of health conditions is needed to raise awareness of the medical need of populations, to convince donors of the magnitude of treatable conditions and to provide policy makers and ministries of health with the requisite data needed to plan interventions. To address these deficiencies for surgical conditions in Sierra Leone, community-level research to quantify the surgical need of the population is needed.


The purpose of this study is to assess the prevalence of surgical conditions in Sierra Leone. The study has six arms, which are interlinked:
1. Repeat the Surgeon Over Seas Surgical Assessment Survey (SOSAS) from 2012, which was piloted in Sierra Leone. The original SOSAS study has already been performed in several other African and Asian countries, but never before conducted twice in the same country.
2. Establish the prevalence of lower urinary tract symptoms (LUTS) among men 12 years or older, including an evaluation of health-seeking behaviour.
3. Establish the prevalence and incidence of groin hernia and health-seeking behaviour.
4. Establish the prevalence of wounds in Sierra Leone and health-seeking behaviour.
5. Establish the need for surgical female and obstetrical care in Sierra Leone, describe maternal and neonatal outcomes and their development in the pre-, during and post- Ebola time frame.
6. Establish the rates of surgical procedures performed per year and determine contributions of the public and private sector.

Ethics approval

Current ethics approval as of 12/11/2019:
1. Approved 03/10/2019, Office of the Sierra Leone Ethics and Scientific Review Committee ([SLERC], Directorate of Training and Research, Ministry of Health and Sanitation, 5th Floor, Youyi Building, Brookfields, Freetown; no telephone number; efoday@health.gov.sl), ref: none
2. Approved 28/10/2019, Regional Committee for Medical and Health Research Ethics, Central Norway (post@helseforskning.etikkom.no), ref: 31932

Previous ethics approval:
1. Approved 03/10/2019, Office of the Sierra Leone Ethics and Scientific Review Committee ([SLERC], Directorate of Training and Research, Ministry of Health and Sanitation, 5th Floor, Youyi Building, Brookfields, Freetown; no telephone number; efoday@health.gov.sl), ref: none
2. Pending, REC North - Secretariat (Nordland, Troms and Finnmark) (UiT Norges Arktiske Universitet, Postboks 6050, Langnes, 9037 Tromsø, Norway; +47 77 64 61 40; rek-nord@asp.uit.no)

Study design

Cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Home

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Need for surgery in Sierra Leone

Intervention

The household will be selected from the randomly selected enumeration areas. In the household the head of household will be informed about the study and informed consent will be asked and written consent obtained if applicable. The first part of the questionnaire (Parts A to D) will be taken if informed consent is given from the household representative. Parts E to N from the questionnaire are answered by two randomly selected household members. They will be asked for separate informed consent. It is estimated that 1 h will be needed for interview time per randomly selected person. They will be asked questions about health problems they have had and the treatment they received. If specific conditions are identified, there is a referral and transport protocol for the participants.

If one of the selected household members is under the age of 12 years, that person needs a chaperone to assist. This can be any of the present and available household members over the age of 18 years.

Intervention type

Other

Phase

Drug names

Primary outcome measure

SOSAS Repeat sub-study:
1. Demographic data including age, gender, level of education, occupation and ethnic background
2. Medical information, including health status, medical history, current complaints and clinical symptoms, complete head-to-toe verbal examination, health seeking behaviour, pregnancy history

Lower Urinary Tract Syndrome (LUTS) sub-study:
3. Medical information, including medical history, current complaints and clinical symptoms, health-seeking behaviour, outcome of Uflow meter

Groin Hernia sub-study:
4. Medical information, including medical history, current complaints and clinical symptoms, health-seeking behaviour, findings of physical examination

Wounds sub-study:
5. Medical information, including medical history, lifestyle, current illnesses and medication, clinical symptoms, health seeking behaviour, photograph of wound

Women's Health sub-study:
6. Medical information, including medical history, current complaints and clinical symptoms, health-seeking behaviour, family planning, pregnancy history, perinatal death, symphyseal-fundal height measured with tape measure

Surgical Volume sub-study:
7. Medical information, including medical history of deceased household members, medical history, visits to health care facilities in the past, health-seeking behaviour


Secondary outcome measures

SOSAS Repeat sub-study:
Demographic data including age, gender, level of education, occupation and ethnic background

Overall trial start date

01/09/2018

Overall trial end date

20/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

SOSAS Repeat sub-study:
Two randomly selected household individuals who give informed consent

Lower Urinary Tract Syndrome (LUTS) sub-study:
Men and boys aged >12 years among the two randomly selected household individuals

Groin Hernia sub-study:
Two randomly selected household individuals

Wounds sub-study:
Two randomly selected household individuals

Women's Health sub-study:
Females aged 12-50 years among the two randomly selected household individuals

Surgical Volume sub-study:
All household members who have had a surgical procedure in past year

Participant type

Mixed

Age group

All

Gender

Both

Target number of participants

1873 household representatives (1873 households) for first part of the survey; 3746 randomly assigned household members for second part of the survey.

Participant exclusion criteria

1. No informed consent given
2. Does not meet inclusion criteria of sub-study

Recruitment start date

16/10/2019

Recruitment end date

20/12/2019

Locations

Countries of recruitment

Sierra Leone

Trial participating centre

Masanga Medical Research Unit
Masanga Hospital, Masanga, Tonkolili district
Masanga
-
Sierra Leone

Sponsor information

Organisation

CapaCare

Sponsor details

c/o Dr. Håkon Bolkan
St.Olavs Hospital Kirurgisk avdeling
Postboks 3250
Sluppen
Trondheim
N-7006
Norway
-
post@capacare.org

Sponsor type

Charity

Website

https://capacare.org

Organisation

Masanga Medical Research Unit

Sponsor details

Masanga Hospital
Masanga
Tonkolili District
Sierra Leone
Masanga
-
Sierra Leone
+23278029683
medicalofficer@masanga.dk

Sponsor type

Hospital/treatment centre

Website

http://masangahospital.org

Funders

Funder type

Charity

Funder name

CapaCare

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Masanga Medical Research Unit

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Statistics Sierra Leone

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

All the six arms have the aim to publish their results in appropriate journals.

IPD sharing statement:
A managed access procedure will be developed to allow access to other researchers that wish to use the study data for secondary analysis after the closure of the study. These data will not be made openly accessible in line with national, European and international legal, ethical and privacy concerns. Access to the data will be controlled by principal investigator Håkon A. Bolkan and the senior board of PSSC’19. After the study has been completed and the main study paper published, then researchers can apply to principal investigator Håkon A. Bolkan with proposals to access the study data set for future studies. Access to the data set requires approval from the Steering Committee, which comprises representatives from each consortium partner and is chaired by Håkon A. Bolkan. Researchers will additionally need to sign a Data Sharing Agreement to protect the integrity and confidentiality of the requested data. Any shared data will be further minimised and anonymised as much as possible for the requested purpose.

Intention to publish date

01/04/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/11/2019: The ethics approval information has been changed. 16/10/2019: The following changes have been made to the trial record: 1. Two scientific contacts have been added. 2. Uploaded protocol Version 2.3 01 September 2019 (not peer-reviewed) 15/10/2019: Trial's existence confirmed by Sierra Leone Ethics and Scientific Review Committee.