Elisa Mäkäräinen, Matti Tolonen, Ville Sallinen, Panu Mentula, Ari Leppäniemi, Mirella Ahonen-Siirtola, Juha Saarnio, Pasi Ohtonen, Filip Muysoms, Tero Rautio, Prophylactic retrorectus mesh versus no mesh in midline emergency laparotomy closure for prevention of incisional hernia (PREEMER): study protocol for a multicentre, double-blinded, randomized controlled trial, BJS Open, Volume 6, Issue 1, February 2022, zrab142, https://doi.org/10.1093/bjsopen/zrab142
Prophylactic retrorectus mesh versus no mesh in midline emergency laparotomy closure for prevention of incisional hernia (PREEMER) : study protocol for a multicentre, double-blinded, randomized controlled trial
|Author:||Mäkäräinen, Elisa1; Tolonen, Matti2; Sallinen, Ville2;|
1Department of Surgery, Medical Research Center, Oulu University Hospital , Oulu, Finland
2Department of Surgery, Helsinki University Hospital , Helsinki, Finland
3Hospital AZ Maria Middelares , Ghent, Belgium
|Online Access:||PDF Full Text (PDF, 0.3 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe2022081855768
John Wiley & Sons,
|Publish Date:|| 2022-08-18
Background: Despite the fact that emergency midline laparotomy is a risk factor for an incisional hernia, active research on hernia prevention in emergency settings is lacking. Different kinds of meshes and mesh positions have been studied in elective abdominal surgery, but no randomized controlled trials in emergency settings have been published thus far.
Methods: The PREEMER trial (registration number NCT04311788) is a multicentre, patient- and assessor-blinded, randomized controlled trial to be conducted in six hospitals in Finland. A total of 244 patients will be randomized at a 1 : 1 ratio to either the retrorectus mesh group, featuring a self-gripping prophylactic mesh, or to the no mesh (control) group, both closed by small-stitch 4 : 1 closure with continuous slowly absorbable monofilament suturing. The primary outcome of the PREEMER trial is the incidence of incisional hernia 2 years after surgery, which will be detected clinically and/or radiologically. Secondary outcomes are the Comprehensive Complication Index score, incidence of surgical-site infections and fascial dehiscence within 30 days of surgery; the incisional hernia repair rate and mesh- or hernia-related reoperations within the 2- and 5-year follow-ups; the incidence of incisional hernia within the 5-year follow-up; and quality of life measured by RAND-36, the Activities Assessment Scale and the PROMIS questionnaire within 30 days and 2 and 5 years from surgery. Additionally, health–economic explorative measures will be explored.
Conclusions: The PREEMER trial will provide level 1 evidence on incisional hernia prevention in an emergency setting.
Registration number: NCT04311788 (http://www.clinicaltrials.gov). Registered 7 March 2020
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3126 Surgery, anesthesiology, intensive care, radiology
The PREEMER Trial has been funded by Mary and Georg C. Ehrnrooth Foundation and European Hernia Society. The materials used within this study are funded by the hospital districts. Funders of the trial do not have any role in study design, outcome analysis or interpretation of the data, writing the report or the decision to submit the report.
© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.