Condition category
Digestive System
Date applied
09/01/2012
Date assigned
08/02/2012
Last edited
21/02/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.entreppment.nl

Contact information

Type

Scientific

Primary contact

Dr Willem Bökkerink

ORCID ID

Contact details

Radboud University Nijmegen Medical Center
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands

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 measures

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

20/08/2016

Reason abandoned

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

http://www.umcn.nl/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23452397

Publication citations

  1. 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.

Additional files

Editorial Notes