Hysterectomy
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 robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.
Interventions
PROCEDUREHysterectomy with adnexal surgery
Robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.
Sponsors
Distalmotion SA
Confinis
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| primary safety endpoint | up to 42 days | occurrence of Clavien - Dindo grades III-V adverse events |
| primary performance endpoint | intraoperative | successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach |
Countries
France, Switzerland
Outcome results
None listed