Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
University of Oulu
Collaborating Sponsors:
Helsinki University Central Hospital
Conditions:
Incisional Hernia
Emergency Laparotomy
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
Incisional hernia (IH) is a common complication of abdominal wall surgery. Its' incidence varies greatly (2-30 %) among studies. The incisional hernia incidence is influenced by several factors, such ...
Eligibility Criteria
Inclusion
- Midline emergency laparotomy for any gastrointestinal indication
Exclusion
- • 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
- Subject participates in another RCT Intra-operative exclusion criteria applicable for both randomization groups
- 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
- Intra-abdominal malignancy diagnosed at the operation
- \>2 cm hernia in midline
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2028
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04311788
Start Date
April 27 2020
End Date
March 1 2028
Last Update
February 1 2024
Active Locations (7)
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1
Jorvi Hospital
Espoo, Finland
2
Helsinki University Hospital
Helsinki, Finland
3
Lahti Central Hospital
Lahti, Finland
4
Oulu University Hospital
Oulu, Finland