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OpenTrials
Completed

NCT Number: NCT05873582

Robotic Minimally Invasive Inguinal Hernia Repair With Dexter

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.

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Key information

Conditions

Inguinal Hernia Repair

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Saintes, Saintes, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic-Assisted Inguinal Hernia Repair

Device

Primary transperitoneal unilateral or bilateral inguinal hernia repair with the Dexter robotic system

Primary outcomes

  1. Safety: occurrence of serious (Clavien - Dindo grades III-V), device-related, adverse events

    Time frame: perioperatively up to 30 days

  2. Performance: successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

Distalmotion SA

Industry

Collaborators

  • Confinis

Registry information

Acronym: RAS-Ahead

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 24, 2023
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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