Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for Prevention of Incisional Hernia: a Multi Center, Double-blind, Randomized Controlled Trial
1 other identifier
interventional
109
1 country
7
Brief Summary
244 patients, who have an emergency midline laparotomy for any gastrointestinal reason, will be randomized in a 1:1 ratio either to mesh group with a retrorectus prophylactic self-gripping mesh or to control group with 4:1 small stitch closure by continuous monofilament suture. They will be followed up at 30 days, 2 and 5 years to detect the incidence of incisional hernia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedStudy Start
First participant enrolled
April 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
ExpectedFebruary 1, 2024
January 1, 2024
4.8 years
March 7, 2020
January 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of incisional hernia
Incidence of incisional hernia, either symptomatic or asymptomatic detected clinically and/or radiologically
2 years
Secondary Outcomes (10)
Comprehensive Complication Index
30 days
Surgical site infection (SSI) rate
30 days
Fascial rupture
30 days
Incisional hernia
5 years
Incisional hernia repair rate
5 years
- +5 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALProphylactic self gripping mesh (Program, Medtronic) will be placed in rectorectus space to prevent incisional hernia.
Control group
ACTIVE COMPARATORAbdomen of the patients in the control group will be closed by using small stitch closure with suture to wound length of 4:1 and slowly absorbable monofilament suture.
Interventions
Prophylactic self gripping mesh, Propgrip by Medtronic.
Fascial closure by continuous slowly absorbable 4:1 suture
Eligibility Criteria
You may qualify if:
- Midline emergency laparotomy for any gastrointestinal indication
You may not qualify if:
- Previous ventral hernia repair with mesh in the midline
- Previous inguinal or femoral hernia repair by any technique with mesh is accepted
- Previous WHO class of physical activity 3-4 (WHO 3 more than 50% of time at rest, WHO 4 stays at rest most of the time)
- Relaparotomy
- Indication for laparotomy is incarcerated hernia
- Pregnant or suspected pregnancy
- \<18 years
- Metastastic malignancy of any origin
- Planned osteomyelitis
- Patients living geographically distant and/or unwilling to return for follow-ups
- No informed consent
- Abdomen is left open
- Second look laparotomy planned
- Ostomy created at the operation
- Inability to keep the mesh securely out of the peritoneal cavity or close the anterior fascia
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oululead
- Helsinki University Central Hospitalcollaborator
Study Sites (7)
Jorvi Hospital
Espoo, Finland
Helsinki University Hospital
Helsinki, Finland
Lahti Central Hospital
Lahti, Finland
Oulu University Hospital
Oulu, Finland
Seinäjoki Central Hospital
Seinäjoki, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Related Publications (2)
Makarainen E, Tolonen M, Sallinen V, Mentula P, Leppaniemi A, Ahonen M, Saarnio J, Pinta T, Lampela H, Malmi H, Lietzen E, Nikki M, Ohtonen P, Muysoms F, Rautio T. Prophylactic Retrorectus Mesh Versus Small-Stitch Closure After Emergency Midline Laparotomy: 2-Year Results of a Randomized Controlled Trial. J Abdom Wall Surg. 2025 Nov 27;4:15500. doi: 10.3389/jaws.2025.15500. eCollection 2025.
PMID: 41394095DERIVEDMakarainen E, Tolonen M, Sallinen V, Mentula P, Leppaniemi A, Ahonen-Siirtola M, Saarnio J, Ohtonen P, Muysoms F, Rautio T. 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. 2022 Jan 6;6(1):zrab142. doi: 10.1093/bjsopen/zrab142.
PMID: 35143628DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elisa Mäkäräinen-Uhlbäck, M.D.
Oulu University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 7, 2020
First Posted
March 17, 2020
Study Start
April 27, 2020
Primary Completion
February 3, 2025
Study Completion (Estimated)
March 1, 2028
Last Updated
February 1, 2024
Record last verified: 2024-01