Plain English Summary
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
Dr Jenny Löfgren
Institutionen för molekylär medicin och kirurgi
Karolinska Universitetssjukhuset Solna (L1:00)
Outcomes after low cost mesh repair of inguinal hernia performed by surgeons and non-surgeons in Ghana: an interventional prospective study
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.
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
Interventional prospective study
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
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.
Primary outcome measures
1. Recurrence, measured by clinical examination at 3 years postoperatively
2. Postoperative complications, measured by clinical examination at 2 weeks postoperatively
Secondary outcome measures
1. Chronic pain, measured using a validated tool (the Inguinal Pain Questionnaire) at 3 years
2. Patient satisfaction, assessed through a questionnaire-based interview at 3 years
3. Health outcome, assessed through a questionnaire-based interview at inclusion and at 3 years
Overall trial start date
Overall trial end date
Participant 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
Target number of participants
Participant exclusion criteria
3. Recurrent hernia
4. Inability to give informed consent
5. Obvious alcohol or substance abuse
6. Known coagulopathy
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Ho Regional Referral Hospital
Swedish Research Council, VR
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal. More than one paper is planned, and the first will be following the 1-year reviews.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jenny Löfgren.
Intention to publish date
Participant level data
Available on request
Results - basic reporting