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

Study Timeline

• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-24
• Study Start: 2023-06-02
• Primary Completion: 2023-10-23
• Study Completion: 2023-10-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

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

Trial Locations

Locations (3)

Kantonspital Winterthur; 🇨🇭 Winterthur, Switzerland

Centre Hospitalier de Saintes; 🇫🇷 Saintes, France

UKSH Kiel; 🇩🇪 Kiel, Germany