Ventral Hernia Repair
Conditions
Brief summary
The aim of this clinical investigation is to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing incisional or primary ventral hernia repair.
Interventions
DEVICEventral hernia repair
Robotic-assisted incisional or primary ventral hernia repair with the DEXTER robotic surgery system
Sponsors
Distalmotion SA
Confinis
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged \> 18 years * Planned to undergo incisional and primary midline ventral (M2-M4; epigastric, umbilical and infraumbilical) hernia repair smaller and equal to 8cm * Patient agrees to perform the 30-day follow-up assessment, as per standard of care
Exclusion criteria
* Any planned concomitant procedures * Active anticoagulant treatment * Recurring hernia with mesh during primary hernia repair * Need for transversal abdominal release * Patients under corticosteroids or other immunosuppressive treatment * Loss of domain type of hernia * Previous incision extending from xiphoid process to pubic bone (= Median laparotomy M1 to M5) * M2 hernia extending to M1 and/or M4 hernia extending to M5 * Ongoing intra-abdominal infection or septic state * Abdominal fistulae * History of major\* abdominal or pelvic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary safety 0utcome | 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 conversion to an open or fully laparoscopic surgical approach |
Countries
Austria, France, Germany, Switzerland
Outcome results
None listed