The Impact of Fibrin fixation of macroporous mesheS in TransAbdominal PrePeritoneal hernia repair

ISRCTN	ISRCTN41994541
DOI	https://doi.org/10.1186/ISRCTN41994541
Secondary identifying numbers	CT1

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Rene Fortelny
Scientific

2nd Department of Surgery
Wilhelminenspital
Montleartstr. 37
Vienna
1200
Austria

Phone	+43 (0)14 915 00
Email	rene.fortelny@wienkav.at

Study design	Prospective, randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Scientific title	The Impact of Fibrin fixation of macroporous mesheS in TransAbdominal PrePeritoneal hernia repair
Study acronym	FSTAPP
Study objectives	Reduction of postoperative pain and improved quality of life due to the use of atraumatic mesh fixation with a tissue sealant.
Ethics approval(s)	Granted by local ethics committee (Ethikkommission der Stadt Wien) on the 30th June 2006 (ref: EK 06-019-0306).
Health condition(s) or problem(s) studied	Primary unilateral- and bilateral inguinal hernia
Intervention	Transabdominal laparoscopic inguinal hernia repair in general anaesthesia. The operation is a standard procedure.
Intervention type	Other
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 study start date	01/05/2006
Completion date	01/05/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	100
Total final enrolment	89
Key inclusion criteria	1. Age between 18 and 70 years 2. Primary uni- and bilateral inguinal hernia
Key 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
Date of first enrolment	01/05/2006
Date of final enrolment	01/05/2009

2nd Department of Surgery

Vienna
1200
Austria

Ludwig Boltzmann Institute for Traumatology (Austria)
Research organisation

Donaueschingenstr. 13
Vienna
1200
Austria

Research organisation

Ludwig Boltzmann Institute for Traumatology, Cluster for Tissue Regeneration (Austria)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/01/2012	12/04/2021	Yes	No

12/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.