Outcomes after low cost mesh repair of inguinal hernia performed by surgeons and non-surgeons in Ghana
| ISRCTN | ISRCTN17133375 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17133375 |
| Protocol serial number | 1 |
| Sponsor | Karolinska Institutet |
| Funder | Vetenskapsrådet |
- Submission date
- 26/07/2017
- Registration date
- 21/08/2017
- Last edited
- 03/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
A hernia occurs when an internal part of the body pushes through a weakness in the muscle or surrounding tissue wall. An inguinal hernia is the most common type of hernia and can appear as a swelling or lump in the groin or as an enlarged scrotum. Inguinal hernia repair is one of the most commonly performed surgical procedures, especially in sub-Saharan Africa. However, 200 million patients living with inguinal hernia do not receive necessary surgical care each year. In Uganda, the met need for inguinal hernia surgery is less than 1% per year. Using mesh for inguinal hernia repair significantly reduces the risk of hernia recurrence. However, most inguinal hernias are repaired using tissue techniques in resource-constrained settings. A commercial mesh costs over 100 USD and more than doubles the cost of a hernia repair in Uganda. A recent study shows that a mosquito net, which comes at a fraction of the cost, is a safe and effective alternative to commercial mesh for elective inguinal hernia repair. Major surgery is rarely performed by qualified surgeons in sub-Saharan Africa. Task-sharing of surgical procedures with non-surgeons is practiced in many African countries to various extents, depending on national policies. In sub-Saharan Africa, non-surgeon physicians and Non-Physician Clinicians (NPCs) commonly perform inguinal hernia repair. The aim of this study is to assess the outcomes after low cost mesh repair of inguinal hernia performed by surgeons and non-surgeons in Ghana.
Who can participate?
Men aged 18 and above with a groin hernia
What does the study involve?
Surgeons and non-surgeon medical officers are trained to perform mesh hernia repair under local anaesthetic. Patients undergo mesh hernia repair surgery and are followed up after 2 weeks and after 1 and 3 years to assess whether the hernia comes back (recurrence), complications, pain and satisfaction. Cost and cost-effectiveness are calculated.
What are the possible benefits and risks of participating?
The participants receive a hernia mesh repair at a reduced cost. There are no risks in addition to the risks that are always associated with surgery.
Where is the study run from?
Ho Regional Referral Hospital (Ghana)
When is the study starting and how long is it expected to run for?
January 2016 to December 2021
Who is funding the study?
Swedish Research Council
Who is the main contact?
Dr Jenny Löfgren
Contact information
Scientific
Institutionen för molekylär medicin och kirurgi
Karolinska Institutet
Karolinska Universitetssjukhuset Solna (L1:00)
Stockholm
17176
Sweden
 ORCID ID |
0000-0001-5884-0369 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional prospective study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Outcomes after low cost mesh repair of inguinal hernia performed by surgeons and non-surgeons in Ghana: an interventional prospective study |
| Study objectives | The hypothesis is that groin hernia repair can be performed by both surgeons and non-surgeon medical doctors with similar results in terms of recurrence, postoperative complications, and patient satisfaction. |
| Ethics approval(s) | 1. Ghana Health Service Ethics Review Committee (GHS-ERC), 01/10/2016, ref: GHS-ERC:01/10/16 2. University of Pennsylvania, Institutional Review Board, ref: 825122 |
| Health condition(s) or problem(s) studied | Groin hernia |
| Intervention | Surgeons and non-surgeon medical officers will be trained to perform mesh hernia repair under local anaesthesia. After completion of the training, patients will be included into the study. They will be followed up after two weeks, after one and three years. Follow up will specifically include evaluation of recurrence, postoperative complications, chronic pain and patient satisfaction. Cost and cost-effectiveness will be calculated. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Recurrence, measured by clinical examination at 3 years postoperatively |
| Key secondary outcome measure(s) |
1. Chronic pain, measured using a validated tool (the Inguinal Pain Questionnaire) at 3 years |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 250 |
| Total final enrolment | 242 |
| Key inclusion criteria | 1. Adult male with primary, reducible, groin hernia 2. Healthy (ASA 1 and 2) 3. Ability to give informed consent 4. Adults (aged 18 and above), no upper age limit |
| Key exclusion criteria | 1. Women 2. Children 3. Recurrent hernia 4. Inability to give informed consent 5. Obvious alcohol or substance abuse 6. Known coagulopathy |
| Date of first enrolment | 15/02/2017 |
| Date of final enrolment | 15/10/2017 |
Locations
Countries of recruitment
- Ghana
Study participating centre
-
Ghana
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jenny Löfgren. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2019 | 03/07/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/07/2019: Publication reference and total final enrolment number added.
