Evaluating robotic inguinal hernia repair techniques
A Multicenter Comparative Prospective Observational Cohort Study About Robot-assisted Laparoscopic Inguinal Hernia Repair Using Two Different Robotic Systems
This study is testing how long it takes to perform robotic hernia surgery using a new system compared to an older one to see if it can be done more efficiently while keeping track of patient recovery and any complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Algemeen Ziekenhuis Maria Middelares Academic / other |
| Locations | 2 sites (Deinze and 1 other locations) |
| Trial ID | NCT06599515 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to assess the operative time for robotic-assisted laparoscopic inguinal hernia repair using the HugoTM RAS system during the learning curve of the first 50 patients. The study will compare these results with the operative times from a similar cohort treated with the daVinci Xi robotic system by the same surgeon at a different hospital. The research involves preclinical testing and validation of a setup guide developed from cadaveric and dummy models. Patient data will be collected, and a one-month postoperative follow-up will evaluate short-term complications and quality of life.
Who should consider this trial
Good fit: Ideal candidates include adults scheduled for minimally invasive robotic-assisted laparoscopic inguinal hernia repair.
Not a fit: Patients with recurrent hernias after previous mesh placement or those requiring emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the efficiency and outcomes of robotic inguinal hernia repairs.
How similar studies have performed: Other studies have shown success with robotic-assisted techniques, suggesting potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients planned for a minimal invasive (robotic assisted laparoscopic) inguinal hernia repair during the study period will be invited to take part in the study. Both unilateral and bilateral hernias will be included. Exclusion Criteria: * Recurrent hernias after previous preperitoneal mesh placement. * Inguinal hernias after abdominal prostatectomy. * Pregnancy. * Emergency surgery. * Age below 18 years. * Absence of informed consent.
Where this trial is running
Deinze and 1 other locations
- AZ Sint-Vincentius — Deinze, Belgium (Recruiting)
- AZ Maria Middelares — Ghent, Belgium (Not_yet_recruiting)
Study contacts
- Study coordinator: Filip Muysoms, MD, PhD
- Email: Filip.Muysoms@mijnziekenhuis.be
- Phone: +32 9 246 74 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.