Comparing open and robotic-assisted surgery for ventral hernia repair
Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome
This study tests whether robotic-assisted surgery is better than traditional open surgery for fixing ventral hernias in patients, looking at things like recovery, pain, and satisfaction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 1 site (Aabenraa, Southern Denmark) |
| Trial ID | NCT05906017 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the outcomes of conventional open surgery with robotic-assisted surgery for repairing ventral hernias in patients with midline abdominal wall defects. A total of 60 patients will be randomly assigned to either surgical approach, and their short and long-term complications will be assessed through clinical evaluations and patient-reported outcomes, including pain levels, cosmetic results, and overall satisfaction. Additionally, the study will analyze the surgical stress response using various biomarkers and conduct a cost-effectiveness analysis of both procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a clinical and radiologic diagnosis of midline ventral hernia who are eligible for surgery.
Not a fit: Patients with incarcerated hernias requiring emergency surgery, pregnancy, chronic pain conditions, current cancer diagnosis, psychiatric disorders, or a BMI over 40 kg/m2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which surgical method offers better outcomes for patients undergoing ventral hernia repair.
How similar studies have performed: Other studies have explored robotic-assisted surgeries with promising results, but this specific comparison of open versus robotic-assisted ventral hernia repair is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aabenraa, Southern Denmark
- Sygehus Sønderjylland — Aabenraa, Southern Denmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Kristian Als Nielsen
- Email: Kristian.Als.Nielsen3@rsyd.dk
- Phone: +45 79 97 00 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.