Inguinal Hernia Repair
Conditions
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.
Interventions
Primary transperitoneal unilateral or bilateral inguinal hernia repair with the Dexter robotic system
Sponsors
Confinis
Distalmotion SA
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France, Germany, Switzerland
Outcome results
None listed