Robotic Minimally Invasive Inguinal Hernia Repair With Dexter (RAS-Ahead)

Distalmotion

Status: Completed

Conditions: Inguinal Hernia Repair

Treatments: Device: Robotic-assisted inguinal hernia repair

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05873582

2023-01

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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