Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome (NCT05906017) | Clinical Trial Compass
CompletedNot Applicable
Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome
Denmark56 participantsStarted 2023-05-15
Plain-language summary
In this randomized clinical trial, the investigators will compare the conventional open repair for hernia in the anterior abdominal wall with the robotic-assisted approach. 60 patients with midline abdominal wall defects will be randomized to either open or robotic-assisted surgery. The investigators will examine short and long-term complications through follow-up with clinical assessment as well as patient-reported outcome measures including pain, cosmetic appearance, and overall patient satisfaction. Furthermore, the investigators will study the difference in surgical stress response between the two methods measured from a variety of different biomarkers before and after the operation. A cost-effective analysis will be conducted for the robotic and open procedure.
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
* ASA 1-3
* Clinical and radiologic diagnosis of midline ventral hernia
* Eligible to surgery according to a preoperative anaesthetic assessment
* Informed consent
* Able to understand written and oral Danish language
Exclusion Criteria:
* Incarcerated ventral hernia requiring emergency surgery
* Pregnancy
* Patients with chronic pain due to arthritis, migraine or other illness requiring regular intake of analgesics (paracetamol, NSAID, opiates etc).
* Current cancer diagnosis
* History of psychiatric or addictive disorder that prevents the patient from participating in the trial
* Co-existing inflammatory disease
* Co-existing immunological disease that requires medication of any kind
* BMI \>40 kg/m2
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.