RAS-Ahead: Robotic Minimally Invasive Inguinal Hernia Repair With Dexter
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged > 18 years
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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.
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Able to provide Informed Consent according to local regulation
Exclusion Criteria:
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Morbidly obese patients (BMI > 40)
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Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
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Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
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Bleeding diathesis
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Pregnancy
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Patients with pacemakers or internal defibrillators
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Any planned concomitant procedures
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Patient deprived of liberty by administrative or judicial decision or under legal guardianship
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Participation in another interventional clinical trial
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Distalmotion SA
- confinis AG
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-01