The Total Extra Peritoneal (TEP) method versus the Transinguinal Preperitoneal Technique (TIPP) for inguinal hernia repair.

ISRCTN	ISRCTN26433218
DOI	https://doi.org/10.1186/ISRCTN26433218
Secondary identifying numbers	NL31388.091.10

Submission date: 31/01/2010
Registration date: 22/02/2010
Last edited: 13/02/2012

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Mr Giel G Koning
Scientific

Department of Surgery
Radboud University Medical Centre
Geert Grooteplein-Zuid 10
Nijmegen
6525 GA
Netherlands

Study information

Study design	Multicentre randomised active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information material may be found at http//www.gladiola.nl
Scientific title	The Total Extra Peritoneal (TEP) method versus the Transinguinal Preperitoneal Technique (TIPP) for inguinal hernia repair: A multicentre randomised controlled trial.
Study acronym	GLADIOLA
Study objectives	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(s)	METC judgement: waiting for approval
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/03/2010
Completion date	12/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	900
Key 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
Key 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.)
Date of first enrolment	01/03/2010
Date of final enrolment	12/12/2012

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of Surgery,

Nijmegen
6525 GA
Netherlands

Sponsor information

Radboud University Medical Centre, Nijmegen (Netherlands)
Hospital/treatment centre

Department of Surgery
Radboud University Medical Centre
Geert Grooteplein-Zuid 10
Nijmegen
6525 GA
Netherlands

Phone	+31 (0)24 3611111
Email	g.koning@chir.umcn.nl
Website	http://www.umcn.nl/Zorg/Afdelingen/Heelkunde
"ROR"	https://ror.org/05wg1m734

Funders

Funder type

Hospital/treatment centre

Radboud University Medical Centre, Nijmegen (Netherlands)

No information available

Results and Publications

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