Inguinal hernias - epidemiology, mosquito nets and cost effectiveness
| ISRCTN | ISRCTN20596933 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20596933 |
| Secondary identifying numbers | 2012/1 |
- Submission date
- 09/01/2012
- Registration date
- 16/02/2012
- Last edited
- 10/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
Background and study aims
An inguinal hernia occurs when fatty tissue or a part of the bowel pokes through into the groin. They are usually painful and may occasionally even cause death. Surgical repair of inguinal hernias is one of the most common procedures in sub-Saharan Africa. In high-income countries, the repair is usually done with a plastic mesh. It has been proven many times to be vastly superior to non-mesh repair methods. In low- and middle-income countries, these meshes are almost always too expensive for most people, who are therefore treated by outdated methods with a poor outcome. The use of locally available sterilized mosquito nets in hernia repair appears to be a promising alternative. The aim of this study is to find out whether the use of commercial mesh and mosquito nets are comparable in terms of outcome.
Who can participate?
Men aged over 18 with an inguinal hernia.
What does the study involve?
Participants are randomly allocated to have a hernia repair using either a standard commercial mesh or a sterilized mosquito net of similar size. They are followed for at least a year to see if there is any difference in complications, pain and recurrence between the groups. We also calculate the cost-effectiveness of these two forms of hernia repair.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Karolinska Institute (Sweden)
When is the study starting and how long is it expected to run for?
February 2012 to June 2014
Who is funding the study?
Swedish Medical Society, Karolinska Institute, Golje Foundation and Capio Foundation (Sweden).
Who is the main contact?
Dr Andreas Wladis
awladis@gmail.com
Contact information
Scientific
Karolinska Institute
St Göran's Hospital
St Göransplan 1
Stockholm
112 81
Sweden
| awladis@gmail.com |
Study information
| Study design | Double-blind randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Inguinal Hernia Surgery in Uganda [IHSIU) - a randomized clinical trial comparing commercial mesh and mosquito net in the Lichtenstein Repair of Uncomplicated Inguinal Hernia in the Iganga-Mayuge demographic surveillance site in Uganda |
| Study acronym | IHSIU |
| Study hypothesis | In open, surgical repair of primary inguinal hernias, the use of commercial mesh and mosquito nets are comparable in terms postoperative outcome and different only with regard to cost. |
| Ethics approval(s) | Makerere University, Kampala, Uganda, 05/10/2011, ref: SBSC 006 |
| Condition | Primary inguinal hernias |
| Intervention | Patients will be randomized to have a hernia repair using either a standard commercial mesh or a sterilized mosquito net of similar size |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Postoperative complications 2. Postoperative pain 3. Hernia recurrence 4. Cost-effectiveness |
| Secondary outcome measures | Quality of life |
| Overall study start date | 06/02/2012 |
| Overall study end date | 27/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 380 |
| Participant inclusion criteria | 1. Age > 18 years 2. Male 3. Reducible, unilateral, primary, inguinal hernia 4. The patient accepts participation and gives informed consent |
| Participant exclusion criteria | 1. Female 2. Recurrent hernia 3. Femoral hernia 4. Ongoing anticoagulant medication 5. Current drug abuse 6. ASA group 3 and above |
| Recruitment start date | 06/02/2012 |
| Recruitment end date | 27/06/2014 |
Locations
Countries of recruitment
- Sweden
- Uganda
Study participating centre
112 81
Sweden
Sponsor information
Research organisation
PO Box 738
Stockholm
10135
Sweden
| Phone | +46 (0)8 790 33 00 |
|---|---|
| info@sls.se | |
| Website | http://www.slf.se/Info-in-English/ |
"ROR" |
https://ror.org/016ks4x90 |
Funders
Funder type
Research organisation
No information available
Government organisation / Local government
- Alternative name(s)
- Karolinska Institute, KI
- Location
- Sweden
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/01/2016 | Yes | No | |
| Results article | cost-effectiveness results | 01/05/2017 | Yes | No |
Editorial Notes
10/04/2025: Internal review.
17/02/2017: Publication reference added.
14/01/2016: Publication reference added.
