Condition category
Digestive System
Date applied
09/01/2012
Date assigned
16/02/2012
Last edited
14/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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and middle-income countries, these meshes are almost always too expensive for most people, who are therefore treated by outdated methods with a poor outcome.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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andreas Wladis

ORCID ID

Contact details

Karolinska Institute
St Göran's Hospital
St Göransplan 1
Stockholm
112 81
Sweden
-
awladis@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2012/1

Study information

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

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

Makerere University, Kampala, Uganda, 05/10/2011, ref: SBSC 006

Study design

Double-blind randomized controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

1. Postoperative complications
2. Postoperative pain
3. Hernia recurrence
4. Cost-effectiveness

Secondary outcome measures

Quality of life

Overall trial start date

06/02/2012

Overall trial end date

27/06/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Male

Target number of participants

380

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

Uganda

Trial participating centre

Karolinska Institute
Stockholm
112 81
Sweden

Sponsor information

Organisation

Swedish Medical Society (Sweden)

Sponsor details

PO Box 738
Stockholm
10135
Sweden
+46 (0)8 790 33 00
info@sls.se

Sponsor type

Research organisation

Website

http://www.slf.se/Info-in-English/

Funders

Funder type

Research organisation

Funder name

Swedish Medical Society (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Karolinska Institutet

Alternative name(s)

Karolinska Institute, KI

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Golje Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Capio Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26760085

Publication citations

Additional files

Editorial Notes

14/01/2016: Publication reference added