Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for … (NCT04311788) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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
Finland109 participantsStarted 2020-04-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Midline emergency laparotomy for any gastrointestinal indication
Exclusion Criteria:
* • 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.