Conventional versus keyhole removal of appendix in Nigerian patients
| ISRCTN | ISRCTN16627579 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16627579 |
| Secondary identifying numbers | NHREC/01/01/2007- 11/03/2022 |
- Submission date
- 07/09/2022
- Registration date
- 02/11/2022
- Last edited
- 02/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
We are not sure how much money patients spend on different kinds of operation. This makes it difficult to advise the government and policy makers on investment and spending for healthcare. This study will calculate the amount spent by patients on two types of operation to help with planning for healthcare financing
Who can participate?
Patients who are undergoing operations for removal of the appendix
What does the study involve?
Patients will have their operations done in the usual fashion decided by their surgeon and their hospital. Data regarding their operation, recovery and recuperation will be collected without disclosing the patient’s identity. The researchers will also ask specific questions regarding costs incurred by patients. Patients will be followed up till 30 days after the operation.
What are the possible benefits and risks of participating?
The findings will be communicated to surgeons, hospitals, government and policy makers, not only in Nigeria but across the world. This will influence the policies on surgical operations in Nigeria and other countries. Apart from the time to answer the questions, the researchers will not require anything else from participants. Participation in this study will be at no risk to the patient
Where is the study run from?
Obafemi Awolowo University (Nigeria)
When is the study starting and how long is it expected to run for?
January 2022 to January 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Adewale Adisa, ao.adisa@oauife.edu.ng
Contact information
Principal Investigator
Department of Surgery
Obafemi Awolowo University
Ile-Ife
220005
Nigeria
 ORCID ID |
0000-0003-1927-3992 |
|---|---|
| Phone | +234 (0)8033889425 |
| ao.adisa@oauife.edu.ng |
Study information
| Study design | Outcomes-focused multicenter cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 42342_PIS.pdf |
| Scientific title | Outcomes-focused comparison of laparoscopic and open appendectomy in Nigeria: a multicenter cohort study |
| Study acronym | LOAN |
| Study objectives | There are no significant differences in the outcome of patients with appendectomy operated either by the laparoscopic or open approach across many Nigerian hospitals |
| Ethics approval(s) | Approved 03/06/2022, National Health Research Ethics Committee of Nigeria (Department of Health Planning, Research & Statistics, Federal Ministry of Health, 11th Floor, Federal Secretariat Complex Phase III, Ahmadu Bello Way, Abuja, Nigeria; +234 (0)9 523 8367; chairman@nhrec.net, secretary@nhrec.net, deskofficer@nhrec.net), ref: NHREC/01/01/2007-03/06/2022 |
| Health condition(s) or problem(s) studied | Uncomplicated acute appendicitis |
| Intervention | All patients scheduled for appendectomy who consent to the study will be recruited. One arm is treated by laparoscopic appendicectomy while the other arm is treated by open appendicectomy. They will have their operations done in the usual fashion decided by their surgeon and their hospital. Data regarding their operation, recovery and recuperation will be prospectively collected. Patients will be followed up till 30 days after operation. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Complications measured using the Clavien-Dindo scale at 30 days after the operation |
| Secondary outcome measures | 1. Postoperative length of stay measured as the total number of days spent from the conclusion of operation calculated at the time decision to discharge home is made by a surgeon of sufficient authority 2. Return to normal activities defined as the first-day patients went to work, school, or engaged in the full retinue of premorbid activities (in its broadest sense) after discharge from the hospital 3. Overall cost of operation in Nigerian Naira calculated and reported by the patient, parents, or guardian on day 30 after the operation |
| Overall study start date | 01/01/2022 |
| Completion date | 31/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 1000 |
| Key inclusion criteria | 1. All consenting adults and children of all ages with clinical diagnoses of uncomplicated acute appendicitis. Both elective and emergency appendectomies will be recruited. 2. Patients must provide written informed consent for the operation as per the hospital protocol. Consent for this study will largely be for the inclusion of the patients’ data in the study as well as for follow-up for a minimum of 30 days postoperatively. This consent can be obtained in written or verbal forms. Patients’ right to decline inclusion and or to withdraw from the study at any point must be ensured and this should not interfere in any way with their surgical care. |
| Key exclusion criteria | Complicated acute appendicitis |
| Date of first enrolment | 01/07/2022 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- Nigeria
Study participating centres
220005
Nigeria
Lagos
100254
Nigeria
300001
Nigeria
900211
Nigeria
260101
Nigeria
110271
Nigeria
240101
Nigeria
Sponsor information
University/education
Department of Surgery
Ile-Ife
220005
Nigeria
| Phone | +234 (0)9088743996 |
|---|---|
| nationaldirector@nihrgsulagoshub.org | |
| Website | https://www.oauife.edu.ng |
"ROR" |
https://ror.org/04snhqa82 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| Publication and dissemination plan | The publication will be made in an international peer-reviewed journal |
| IPD sharing plan | IPD will be saved on a personal computer dedicated to the trial and will not be publicly available. Data will only be available to hospital leads and data scientists. Each participating center is currently storing data in an Excel spreadsheet. The researchers however desire to keep their records on the RedCap site after securing funding for the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 21/09/2022 | No | Yes |
Additional files
Editorial Notes
21/09/2022: Trial's existence confirmed by the National Health Research Ethics Committee of Nigeria.
