The ENTREPPMENT trial: comparing treatments for inguinal hernia

Conditions

Inguinal hernia Digestive System Inguinal hernia

W. J. V. Bökkerink, Giel G. Koning, Patrick W. Vriens, R. M. H. G. Mollen, Mitchell J. R. Harker et al. (8 authors)

Annals of Surgery2021-08-0217 citations

Study protocol for a randomized controlled trial for anterior inguinal hernia repair: transrectus sheath preperitoneal mesh repair compared to transinguinal preperitoneal procedure.

Prins MW, Koning GG, Keus EF, Vriens PW, Mollen RM, Akkersdijk WL, van Laarhoven CJ.

2013-03-0310 citations

10.1186/1745-6215-14-65

Interventions

800 patients will be randomised into the two operation techniques compared: 1. TREPP (transrectus sheath preperitoneal mesh repair) (400 participants) 2. TIPP (transing

questionnnaires are filled in (SF-36, EuroQol 3D, pain disability index). Total follow up is 1 year.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Severe adverse events, e.g. postoperative chronic pain, mortality, recurrence, bleeding	—

Secondary

Measure	Time frame
1. Hospital stay 2. Operation time 3. Return to daily activities (e.g. work) 4. Health status 5. Economic evaluation (cost effectiveness)	—

Countries

Netherlands

Outcome results

None listed