The Impact of Fibrin fixation of macroporous mesheS in TransAbdominal PrePeritoneal hernia repair
| ISRCTN | ISRCTN41994541 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41994541 |
| Protocol serial number | CT1 |
| Sponsor | Ludwig Boltzmann Institute for Traumatology (Austria) |
| Funder | Ludwig Boltzmann Institute for Traumatology, Cluster for Tissue Regeneration (Austria) |
- Submission date
- 21/03/2007
- Registration date
- 13/08/2007
- Last edited
- 12/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rene Fortelny
Scientific
Scientific
2nd Department of Surgery
Wilhelminenspital
Montleartstr. 37
Vienna
1200
Austria
| Phone | +43 (0)14 915 00 |
|---|---|
| rene.fortelny@wienkav.at |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Quality of Life assessed with the 36-item Short Form questionaire (SF-36) and pain assessed with the Visual Analoge Scale (VAS). |
| Key secondary outcome measure(s) |
Recurrences, postoperative complications assessed by clinical examination and ultrasound. |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Austria
Study participating centre
2nd Department of Surgery
Vienna
1200
Austria
1200
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/01/2012 | 12/04/2021 | Yes | No |
Editorial Notes
12/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
