Condition category
Surgery
Date applied
31/01/2010
Date assigned
22/02/2010
Last edited
13/02/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

http://www.gladiola.nl

Contact information

Type

Scientific

Primary contact

Mr Giel G Koning

ORCID ID

Contact details

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

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

http://www.umcn.nl/Zorg/Afdelingen/Heelkunde

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

Publication citations

Additional files

Editorial Notes