The ENTREPPMENT trial: comparing treatments for inguinal hernia
| ISRCTN | ISRCTN18591339 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18591339 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/01/2012
- Registration date
- 08/02/2012
- Last edited
- 04/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Radboud University Nijmegen Medical Center
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands
Study information
| Study design | Interventional multi-center randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The ENTREPPMENT trial: the TransREctus sheath Preperitoneal mesh repair Procedure (TREPP) compared to the TransInguinal Preperitoneal Procedure (TIPP): a randomised clinical trial |
| Study objectives | 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(s) | Approval obtained from CMO region Arnhem-Nijmegen on 24/07/2012, ref 2012/060, local ref NL38842.091.12. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 20/02/2014 |
| Completion date | 31/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 800 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 20/02/2014 |
| Date of final enrolment | 20/08/2016 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
6525 GA
Netherlands
Sponsor information
Hospital/treatment centre
Geert Grooteplein-Zuid 10
Nijmegen
6525 GA
Netherlands
| Website | http://www.umcn.nl/ |
|---|---|
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/03/2013 | Yes | No | |
| Abstract results | Abstract provisionally accepted for ESA congress May 2021 Cologne | 02/08/2021 | 04/08/2021 | No | No |
Editorial Notes
04/08/2021: Publication reference added.
09/08/2017: Overall trial end date has been updated from 20/08/2016 to 31/03/2018. Publication and dissemination plan has been added. Participant level data sharing plan has been added. Intention to publish date has been added.
