Condition category
Digestive System
Date applied
21/03/2007
Date assigned
13/08/2007
Last edited
13/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.lbitrauma.org/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes