Plain English 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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Inguinal hernia
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Severe adverse events, e.g. postoperative chronic pain, mortality, recurrence, bleeding
Secondary outcome measures
1. Hospital stay
2. Operation time
3. Return to daily activities (e.g. work)
4. Health status
5. Economic evaluation (cost effectiveness)
Overall trial start date
20/02/2014
Overall trial end date
31/03/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
800
Participant 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)
Recruitment start date
20/02/2014
Recruitment end date
20/08/2016
Locations
Countries of recruitment
Netherlands
Trial participating centre
Radboud University Nijmegen Medical Center
Nijmegen
6525 GA
Netherlands
Sponsor information
Organisation
Radboud University Nijmegen Medical Center (Netherlands)
Sponsor details
Geert Grooteplein-Zuid 10
Nijmegen
6525 GA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Radboud University Nijmegen Medical Center (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
31/03/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23452397
Publication citations
-
Protocol
Prins MW, Koning GG, Keus EF, Vriens PW, Mollen RM, Akkersdijk WL, van Laarhoven CJ, Study protocol for a randomized controlled trial for anterior inguinal hernia repair: transrectus sheath preperitoneal mesh repair compared to transinguinal preperitoneal procedure., Trials, 2013, 14, 65, doi: 10.1186/1745-6215-14-65.