How screening for and treating malaria before surgery affect the overall outcome of surgical patients
| ISRCTN | ISRCTN15551514 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15551514 |
| Secondary identifying numbers | GHS-ERC 021/05/22 |
- Submission date
- 08/10/2022
- Registration date
- 17/10/2022
- Last edited
- 17/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Malaria screening and treatment before and after surgery is not done routinely in the practice of surgery in Ghana. However, there have been reports from a few cross-sectional studies revealing a link between peri-operative malaria infection and poor surgical outcomes in Ghana and other parts of the world. Meanwhile, adverse surgical outcomes continue to pose a significant socio-economic burden on patients, families, communities and health systems globally, particularly in low-middle-income countries like Ghana. We seek to determine the impact of peri-operative malaria screening and treatment on the outcomes of patients who undergoes elective surgeries at the Eastern Regional Hospital, Koforidua.
Who can participate?
Patients at least 6 months old who are to undergo surgery
What does the study involve?
Patients will be divided into two groups. One group will be tested for malaria using microscopy or antigen test. Those who test positive will be given malaria treatment before surgery. Those will test negative will undergo their surgery as planned.
What are the possible benefits and risks of participating?
Benefits: screening and treatment for malaria
Risks: no additional risks
Where is the study run from?
Eastern regional Hospital (Ghana)
When is the study starting and how long is it expected to run for?
July 2022 to November 2022
Who is funding the study?
President's Malaria Initiative, USAID and National Malaria Control Programme (Ghana)
Who is the main contact?
Dr Foster Amponsah-Manu, foster_amponsah@yahoo.com
Contact information
Principal Investigator
Eastern Regional Hospital
P. O . Box 201
Koforidua
-
Ghana
 ORCID ID |
0000-0002-8764-2254 |
|---|---|
| Phone | +233 244655108 |
| foster_amponsah@erhk.org |
Study information
| Study design | Single center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | 42564 Particpant Information Sheet.pdf |
| Scientific title | Impact of peri-operative malaria screening and treatment on surgical outcomes at the Eastern Regional Hospital, Koforidua: a single-blind randomized controlled trial |
| Study acronym | IPMSTSOERHK |
| Study objectives | There will be no difference between surgical outcomes of patients who are screened and/or treated for malaria peri-operatively and those who are not screened or treated for malaria |
| Ethics approval(s) | Approved 18/07/2022, Ghana Health Service Ethics Review Committee (Research and Development Division, P.O. Box MB 190, Accra, Ghana; no telephone number provided; ethics.research@ghsmail.org), ref: GHS/RDD/ERC/Admin/App/22/269 |
| Health condition(s) or problem(s) studied | The effect of perioperative malaria screening on surgical outcomes |
| Intervention | After consent, an eligible participant will be randomly assigned to either screening or comparison group by a computer generated randomisation scheme. Numbers will be generated randomly and put in an opaque envelope. Participants in the screening group will be screened perioperatively for malaria parasites using microscopy and those found to have malaria parasitemia will receive standard malaria treatment with artemisinin combination therapy (ACT). Participants in the control group will not be screened and receive treatment as usual. These two groups of participants would be followed-up to 30 days post-operation while outcomes including surgical site infection, haemorrhage, prolonged hospitalisation, readmission and death will be assessed and recorded. |
| Intervention type | Other |
| Primary outcome measure | Surgical outcomes measured weekly using patient records for a period of 30 days post-op: 1. Length of hospital stay 2. Development of surgical site infections 3. Hemorrhage 4. Readmission 5. Death |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/07/2022 |
| Completion date | 30/11/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 350 |
| Key inclusion criteria | 1. Patient must be at least 6 months old, since under 6 months and congenital malaria are rare 2. Patient must undergo an elective surgical operation involving greater than or equal to 5cm skin incision 3. Patients who consent to participate in the trial |
| Key exclusion criteria | 1. Surgical patient with uncompensated comorbidities 2. Patient is undergoing surgery but had previous surgery in the last 30 days and beforetime of recruitment 3. Patient is undergoing surgery but has an active surgical site infection or any other surgical outcome from procedure that took place before time of recruitment |
| Date of first enrolment | 10/08/2022 |
| Date of final enrolment | 30/10/2022 |
Locations
Countries of recruitment
- Ghana
Study participating centre
Koforidua
N/A
Ghana
Sponsor information
Government
National Malaria Control Program (NMCP)
Public Health Division, Ghana Health Service
P.O. Box KB 493
Accra
-
Ghana
| Phone | +233 21661484 |
|---|---|
| pmicommunications@usaid.gov | |
| Website | https://www.pmi.gov/ |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- U.S. President's Malaria Initiative, US President's Malaria Initiative, The President's Malaria Initiative, PMI
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request foster_amponsah@yahoo.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 14/10/2022 | No | Yes | ||
| Protocol file | 01/05/2022 | 14/10/2022 | No | No |
Additional files
Editorial Notes
14/10/2022: Trial's existence confirmed by Ghana Health Service Ethics Review Committee.
