Contact information
Type
Scientific
Primary contact
Dr Rene Fortelny
ORCID ID
Contact details
2nd Department of Surgery
Wilhelminenspital
Montleartstr. 37
Vienna
1200
Austria
+43 (0)14 915 00
rene.fortelny@wienkav.at
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CT1
Study information
Scientific title
Acronym
FSTAPP
Study hypothesis
Reduction of postoperative pain and improved quality of life due to the use of atraumatic mesh fixation with a tissue sealant.
Ethics approval
Granted by local ethics committee (Ethikkommission der Stadt Wien) on the 30th June 2006 (ref: EK 06-019-0306).
Study design
Prospective, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Primary unilateral- and bilateral inguinal hernia
Intervention
Transabdominal laparoscopic inguinal hernia repair in general anaesthesia. The operation is a standard procedure.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Quality of Life assessed with the 36-item Short Form questionaire (SF-36) and pain assessed with the Visual Analoge Scale (VAS).
Secondary outcome measures
Recurrences, postoperative complications assessed by clinical examination and ultrasound.
Overall trial start date
01/05/2006
Overall trial end date
01/05/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 18 and 70 years
2. Primary uni- and bilateral inguinal hernia
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
1. Unwilling to participate or no insight in purpose of the study
2. Not fluent in the German language
3. Pregnancy
4. Chronic condition/disease associated with permanent pain
Recruitment start date
01/05/2006
Recruitment end date
01/05/2009
Locations
Countries of recruitment
Austria
Trial participating centre
2nd Department of Surgery
Vienna
1200
Austria
Sponsor information
Organisation
Ludwig Boltzmann Institute for Traumatology (Austria)
Sponsor details
Donaueschingenstr. 13
Vienna
1200
Austria
+43 (0)13 311 0464
office@lbitrauma.org
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Ludwig Boltzmann Institute for Traumatology, Cluster for Tissue Regeneration (Austria)
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
Basic results (scientific)
Publication list
Papers with direct influence on this protocol:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=11141220
2. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16424986
Publication citations
-
Katkhouda N, Mavor E, Friedlander MH, Mason RJ, Kiyabu M, Grant SW, Achanta K, Kirkman EL, Narayanan K, Essani R, Use of fibrin sealant for prosthetic mesh fixation in laparoscopic extraperitoneal inguinal hernia repair., Ann. Surg., 2001, 233, 1, 18-25.
-
Novik B, Hagedorn S, Mörk UB, Dahlin K, Skullman S, Dalenbäck J, Fibrin glue for securing the mesh in laparoscopic totally extraperitoneal inguinal hernia repair: a study with a 40-month prospective follow-up period., Surg Endosc, 2006, 20, 3, 462-467, doi: 10.1007/s00464-005-0391-3.