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Inguinal hernias epidemiology, mosquito nets and cost effectiveness
ISRCTN ISRCTN20596933
DOI 10.1186/ISRCTN20596933
ClinicalTrials.gov identifier
EudraCT number
Public title Inguinal hernias epidemiology, mosquito nets and cost effectiveness
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
Serial number at source 2012/1
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.
Lay summary Lay summary under review 3
Ethics approval Makerere University, Kampala, Uganda, on October 5, 2011 ref: SBSC 006
Study design Double blind randomized controlled clinical trial
Countries of recruitment Uganda
Disease/condition/study domain Primary inguinal hernias
Participants - inclusion criteria 1. Age > 18 years
2. Male
3. Reducible, unilateral, primary, inguinal hernia
4. The patient accepts participation and gives informed consent
Participants - exclusion criteria 1. Female
2. Recurrent hernia
3. Femoral hernia
4. Ongoing anticoagulant medication
5. Current drug abuse
6. ASA group 3 and above
Anticipated start date 06/02/2012
Anticipated end date 27/06/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 380
Interventions Patients will be randomized to have a hernia repair using either a standard commercial mesh or a sterilized mosquito net of similar size
Primary outcome measure(s) 1. Postoperative complications
2. Postoperative pain
3. Hernia recurrence
4. Cost-effectiveness
Secondary outcome measure(s) Quality if life
Sources of funding 1. Swedish Medical Society (Sweden)
2. Karolinska Institute (Sweden)
3. Golje Foundation (Sweden)
4. Capio Foundation (Sweden)
Trial website
Publications
Contact name Dr  Andreas  Wladis
  Address Karolinska Institute
St Göran's Hospital
St Göransplan 1
  City/town Stockholm
  Zip/Postcode 112 81
  Country Sweden
  Email awladis@gmail.com
Sponsor Swedish Medical Society (Sweden)
  Address PO Box 738
  City/town Stockholm
  Zip/Postcode 10135
  Country Sweden
  Tel +46 8 790 33 00
  Email info@sls.se
  Sponsor website: http://www.slf.se/Info-in-English/
Date applied 09/01/2012
Last edited 05/03/2013
Date ISRCTN assigned 16/02/2012
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