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11 February 2012
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| [ Print-friendly version ] |
| The Total Extra Peritoneal (TEP) method versus the Transinguinal Preperitoneal Technique (TIPP) for inguinal hernia repair. |
| ISRCTN | ISRCTN26433218 |
| ClinicalTrials.gov identifier | |
| Public title | The Total Extra Peritoneal (TEP) method versus the Transinguinal Preperitoneal Technique (TIPP) for inguinal hernia repair. |
| 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 |
| Serial number at source | NL31388.091.10 |
| 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 |
| Lay summary | Not provided at time of registration |
| Ethics approval | METC judgement: waiting for approval |
| Study design | Multicentre randomised active controlled parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Inguinal hernia |
| Participants - 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 |
| Participants - 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.) |
| Anticipated start date | 01/03/2010 |
| Anticipated end date | 12/12/2012 |
| Status of trial | Stopped |
| Patient information material | Patient information material may be found at http//www.gladiola.nl |
| Target number of participants | 900 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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. |
| Sources of funding | Radboud University Medical Centre, Nijmegen (Netherlands) |
| Trial website | http://www.gladiola.nl |
| Publications | |
| Contact name | Mr Giel G Koning |
| Address |
Department of Surgery,
Radboud University Medical Centre Geert Grooteplein-Zuid 10 |
| City/town | Nijmegen |
| Zip/Postcode | 6525 GA |
| Country | Netherlands |
| Sponsor | Radboud University Medical Centre, Nijmegen (Netherlands) |
| Address |
Department of Surgery,
Radboud University Medical Centre Geert Grooteplein-Zuid 10 |
| City/town | Nijmegen |
| Zip/Postcode | 6525 GA |
| Country | Netherlands |
| Tel | +31 (0)24 3611111 |
| g.koning@chir.umcn.nl | |
| Sponsor website: | http://www.umcn.nl/Zorg/Afdelingen/Heelkunde |
| Date applied | 31/01/2010 |
| Last edited | 04/01/2012 |
| Date ISRCTN assigned | 22/02/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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