Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NL31388.091.10
Study information
Scientific title
The Total Extra Peritoneal (TEP) method versus the Transinguinal Preperitoneal Technique (TIPP) for inguinal hernia repair: A multicentre randomised controlled trial.
Acronym
GLADIOLA
Study hypothesis
TIPP has less adverse events than TEP.
Further reading:
The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique.
Trials. 2009 Sep 25;10:89.
http://www.ncbi.nlm.nih.gov/pubmed/19781069
http://www.controlled-trials.com/isrctn93798494
More information on hernia, treatment and research can be found at http:// www.liesbreukcentrumbrabant.nl
Ethics approval
METC judgement: waiting for approval
Study design
Multicentre randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information material may be found at http//www.gladiola.nl
Condition
Inguinal hernia
Intervention
As of 04/01/2012 the status of this record was changed to 'stopped' as the trial never started.
900 patients will be randomly allocated to anterior
inguinal hernia repair according to the transinguinal preperitoneal technique (TIPP) or totally extra peritoneal (TEP) technique, both with soft mesh.
The total duration of follow-up will be one year, post-operatively.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
1. Incidence of adverse events
2. Chronic pain (Visual Analogue Score [VAS])
Data will be collected by VAS-diary and SF36-list (Health Status / Quality of Life). Digital forms will be filled in by the patients at the outpatient departments at 14 days, 3 months and one year after surgery.
Secondary outcome measures
1. Costs
2. Quality of life (SF-36)
3. Return to daily activities
4. Return to work
Data will be collected by VAS-diary and SF36-list (Health Status / Quality of Life). Digital forms will be filled in by the patients at the outpatient departments at 14 days, 3 months and one year after surgery.
Overall trial start date
01/03/2010
Overall trial end date
12/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Primary groin hernia, unilateral
2. Age > 18, < 80 years
3. American Society of Anaesthesiologists (ASA) classification 1-3
4. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
900
Participant exclusion criteria
1. Recurrences
2. Age <18 or >80 years
3. Scrotal hernia
4. ASA classification >4
5. Acute incarcerated inguinal hernia
6. Psychiatric disease or other factors which make follow up or questionnaires unreliable
7. Previous preperitoneal surgery (e.g. radical prostatectomy)
8. Joint sessions (urology, vasectomy etc.)
Recruitment start date
01/03/2010
Recruitment end date
12/12/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Surgery,
Nijmegen
6525 GA
Netherlands
Sponsor information
Organisation
Radboud University Medical Centre, Nijmegen (Netherlands)
Sponsor details
Department of Surgery
Radboud University Medical Centre
Geert Grooteplein-Zuid 10
Nijmegen
6525 GA
Netherlands
+31 (0)24 3611111
g.koning@chir.umcn.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Radboud University Medical Centre, Nijmegen (Netherlands)
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