Robotic Minimally Invasive Inguinal Hernia Repair With Dexter
Completed
- Conditions
- Inguinal Hernia Repair
- Registration Number
- NCT05873582
- Lead Sponsor
- Distalmotion SA
- Brief Summary
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Aged > 18 years
- Patients planned to undergo elective robot-assisted and laparoscopic surgery for primary unilateral or bilateral inguinal hernia repair using one camera port, two ports for the manipulating instruments, and additional ports as needed.
- Able to provide Informed Consent according to local regulation
Exclusion Criteria
- Morbidly obese patients (BMI > 40)
- Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
- Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
- Bleeding diathesis
- Pregnancy
- Patients with pacemakers or internal defibrillators
- Any planned concomitant procedures
- Patient deprived of liberty by administrative or judicial decision or under legal guardianship
- Participation in another interventional clinical trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: occurrence of serious (Clavien - Dindo grades III-V), device-related, adverse events perioperatively up to 30 days Performance: successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach intraoperative
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the key clinical outcomes of robotic inguinal hernia repair using the Dexter system compared to traditional laparoscopic methods?
How does the Dexter Robotic System improve surgical precision in transperitoneal hernia repair procedures?
What adverse events have been reported in robotic hernia repair trials and how are they managed?
Are there specific patient biomarkers that correlate with better postoperative recovery after robotic hernia repair?
What is the current market landscape for robotic surgical systems in inguinal hernia repair, including competitors to Distalmotion SA's Dexter?
Trial Locations
- Locations (3)
Centre Hospitalier de Saintes
🇫🇷Saintes, France
UKSH Kiel
🇩🇪Kiel, Germany
Kantonspital Winterthur
🇨🇭Winterthur, Switzerland
Centre Hospitalier de Saintes🇫🇷Saintes, France