Laparoscopic Ventral Hernia Repair with Routine Defect Closure Using Su2ura® Approximation Device (NCT04986917) | Clinical Trial Compass
CompletedNot Applicable
Laparoscopic Ventral Hernia Repair with Routine Defect Closure Using Su2ura® Approximation Device
Israel18 participantsStarted 2022-01-19
Plain-language summary
Study includes 5 visits: Screening, Baseline/Surgery, and 14 days, 3 months, 12months Follow-Ups post-surgery. The actual point of enrollment for each subject is considered the day of surgery. Total study duration is up to 12 months post-surgery.
Surgery will be performed under general anesthesia. Standard antibiotic prophylaxis will be administered 30 min prior to skin incision. A surgical assistant will be selected by the PI from the surgical staff of the department.
The procedure will involve placement of laparoscopic ports, reduction of the hernia sac, closure of the defect with the Su2ura® approximation device and fixation of mesh with tacks over the closed defect in an IPOM fashion.
Based on surgeon consideration, primary umbilical hernia defects under 2 cm will be repaired with or without mesh.
Study follow-up visits will take place 14 days, 3 months and 12 months post-surgery.
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
. Age ≥18 years.
. Patient desires an elective surgical repair.
. Patient is able to provide an informed consent.
. Diagnosis of a primary or secondary ventral hernia, with a fascial defect of width no more than 5 cm width in size on clinical examination or imaging scan.
. Body mass index (BMI) of 20-40 kg/m2.
. Candidate for laparoscopic repair based on the operating surgeon's assessment.
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.