Endoscopic Mini/Less Open Sublay(EMILOS) Repair (NCT05912868) | Clinical Trial Compass
CompletedNot Applicable
Endoscopic Mini/Less Open Sublay(EMILOS) Repair
Germany174 participantsStarted 2015-06-25
Plain-language summary
Ventral hernias in the midline of the abdominal wall are one of the most frequent diseases in general and visceral surgery worldwide. The optimal operative technique is still in discussion. The traditional techniques are open sublay or transabdominal intraperitoneal onlay mesh (IPOM) repair. In order to avoid the risks -large trauma to the abdominal wall with pain and infection, lesion of intraabdominal organs - a new hybrid technique - small skin incision, wide endoscopic dissection of the retrorectus space with implantation of a large mesh - was developed (EMILOS -Endoscopic Mini/Less Open Sublay).
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
* Patients with clinical diagnosis of primary or secondary hernia in the midline of the abdominal wall
* Defect size must be between 2 and 10 cm in width associated with a weak abdominal wall(rectus diastasis)
* Patient must be suitable for general anesthesia
* Patient must have given informed consent
* Patient must be able to understand the principles of operation
* Patient must agree to be incluuded in a follow-up program and to be documented in Herniamed registry
Exclusion Criteria:
* Patients below 18 years of age
* Patients with a defect size below 2 cm
* Patients presenting with loss of domain
* Patients not be able to tolerate general anesthesia
* Patients presenting with excess skin tissue
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.
1Since this trial is now completed, has the data been published yet, and what did it show about hernia recurrence rates compared to other repair techniques?
2This trial measured both hernia recurrence and bulging in the midline of the abdominal wall as separate outcomes — can you explain the difference between those two things and why both matter for my situation?
3The EMILOS procedure combines endoscopic and open surgical approaches — how does that compare to the standard repair method you would typically recommend for my type of ventral hernia?
4Since this trial has no listed phase, which suggests it may be a surgical technique study rather than a drug trial, what does that mean for how confident we can be in the safety and effectiveness data it produced?
5Given that this trial is already completed and I wasn't part of it, could the findings from this study influence the surgical approach you might offer me, or are there other ongoing trials I should know about?
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.
What they're measuring
1
Number of patients with Hernia recurrence
Timeframe: three years
2
Number of patients with bulging in the midline of abdominal wall