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The ENTREPPMENT trial: comparing treatments for inguinal hernia
ISRCTN ISRCTN18591339
DOI 10.1186/ISRCTN18591339
ClinicalTrials.gov identifier
EudraCT number
Public title The ENTREPPMENT trial: comparing treatments for inguinal hernia
Scientific title The ENTREPPMENT trial: the TransREctus sheath Preperitoneal mesh repair Procedure (TREPP) compared to the TransInguinal Preperitoneal Procedure (TIPP): a randomised clinical trial
Acronym N/A
Serial number at source N/A
Study hypothesis TREPP will reduce postoperative chronic pain after inguinal hernia repair with 50%, compared to TIPP.

On 21/02/2014 the following changes were made to the trial record:
1. The anticipated start date was changed from 01/06/2012 to 20/02/2014
2. The anticipated end date was changed from 01/06/2014 to 20/08/2016
Lay summary Background and study aims
Hernia (a lump that results from a part of the bowel slipping through a weakness in the abdominal wall) of the groin is a common disease; every year 30,000 hernia repairs are performed in the Netherlands. The main serious adverse event is postoperative chronic pain, not recurrence. A recently completed study showed less postoperative chronic pain after transinguinal hernia repair (TIPP) when compared to Lichtenstein, the reference technique used in the Netherlands.
A new technique transrectus sheath preperitoneal (TREPP) has been developed that is expected to reduce postoperative chronic pain even more. This study will compare both techniques.

Who can participate?
Adults with an American Society of Anesthesiologists (ASA) classification < 4 (not too much comorbidity), with an unilateral hernia of the groin that has never been repaired before.

What does the study involve?
TIPP and TREPP will be compared. When a patient is eligible they will be randomly assigned to receive either a repair by TIPP or by TREPP. They are both open repair techniques.

What are the possible benefits and risks of participating?
There are no benefits.
There are no risks, other than the risk of having surgery.

Where is the study run from?
The study will be performed in five medical centers in the Netherlands (Radboud University Nijmegen Medical Center; Gelderse Vellei Hospital Ede; St Jansdal Hospital Harderwijk; St. Elisabeth Hospital and TweeSteden Hospital Tilburg/Waalwijk).
The lead center is Radboud University Nijmegen Medical Center.

When is the study starting and how long is it expected to run for?
The trial will start mid of 2012, expected time for inclusion is 1-1.5 years. Total follow up is 1 year.

Who is funding the study?
Radboud University Nijmegen Medical Center

Who is the main contact?
Willem Bökkerink
Willem.Bokkerink@radboudumc.nl
Ethics approval Approval obtained from CMO region Arnhem-Nijmegen on 24/07/2012, ref 2012/060, local ref NL38842.091.12.
Study design Interventional multi-center randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Inguinal hernia
Participants - inclusion criteria 1. Primary, unilateral groin hernia
2. Aged 18-80 years
3. American Society of Anaesthesiologists (ASA) Classification 1-3
4. Signed informed consent
Participants - exclusion criteria 1. Recurrent hernia
2. Scrotal/femoral hernia
3. Acute incarcerated inguinal hernia
4. Psychiatric disease or other reasons making follow-up or questionnaires unreliable
5. Previous preperitoneal surgery (e.g. radical prostatectomy)
Anticipated start date 20/02/2014
Anticipated end date 20/08/2016
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 800
Interventions 800 patients will be randomised into the two operation techniques compared:
1. TREPP (transrectus sheath preperitoneal mesh repair) (400 participants)
2. TIPP (transinguinal preperitoneal repair) (400 participants)

Both hernia repairs are performed in day treatment, or with a total stay of 1 night in hospital. Both groups will visit the outpatient department at 6 weeks, 6 months and 12 months.

A physical exam will be done for evaluation of numbness of the operation area; questionnnaires are filled in (SF-36, EuroQol 3D, pain disability index). Total follow up is 1 year.
Primary outcome measure(s) Severe adverse events, e.g. postoperative chronic pain, mortality, recurrence, bleeding
Secondary outcome measure(s) 1. Hospital stay
2. Operation time
3. Return to daily activities (e.g. work)
4. Health status
5. Economic evaluation (cost effectiveness)
Sources of funding Radboud University Nijmegen Medical Center (Netherlands)
Trial website http://www.entreppment.nl
Publications 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23452397
Contact name Dr  Willem  Bökkerink
  Address Radboud University Nijmegen Medical Center
Geert Grooteplein Zuid 10
  City/town Nijmegen
  Zip/Postcode 6525 GA
  Country Netherlands
Sponsor Radboud University Nijmegen Medical Center (Netherlands)
  Address Geert Grooteplein-Zuid 10
  City/town Nijmegen
  Zip/Postcode 6525 GA
  Country Netherlands
  Sponsor website: http://www.umcn.nl/
Date applied 09/01/2012
Last edited 21/02/2014
Date ISRCTN assigned 08/02/2012
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