Right Colectomy
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 right colectomy.
Interventions
Robotic-assisted right colectomy with the DEXTER robotic surgery system
Sponsors
Study design
Eligibility
Inclusion criteria
* Aged \> 18 years * Patient agrees to perform the 30-day follow-up assessment as per standard of care
Exclusion criteria
* History of radiotherapy on the target surgical area * Patients with distant metastasis * Any planned concomitant procedures * History of major abdominal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary safety outcome | up to 30 days after surgery | Occurrence of Clavien-Dindo grades III-V adverse events |
| Primary efficacy outcome | Intraoperative | Successful completion of the Dexter-assisted procedure, i.e. free of any device related conversion to an open or fully laparoscopic surgical approach. |
Countries
France, Germany, Switzerland