Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System (The HYPER Study)

Distalmotion SA52 enrolled

Overview

This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hysterectomy

Interventions

Hysterectomy with adnexal surgeryPROCEDURE

Robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged \> 18 years * Patients planned to undergo elective robot-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease; using one camera port, two ports for the manipulating instruments, and additional ports as needed. 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. * Participation in another interventional clinical trial

Locations (4)

Groupe Hospitalier Saintes - Saint-Jean-d'Angély

Saintes, France

Kantonsspital Baden

Baden, Switzerland

Inselspital Bern

Bern, Switzerland

Spitäler FMI AG

Interlaken, Switzerland

Outcomes

Primary Outcomes

primary safety endpoint

occurrence of Clavien - Dindo grades III-V adverse events

Time frame: up to 42 days

primary performance endpoint

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

Time frame: intraoperative

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.