Sacrocolpopexy
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 sacrocolpopexy or sacrocervicopexy.
Interventions
DEVICEsacrocolpopexy or sacrocervicopexy
Robotic-assisted sacrocolpopexy or sacrocervicopexy 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 * Women with symptomatic stage I or greater pelvic organ prolapse (POP-Q) * Patient agrees to perform the 6-week follow-up assessment as per Standard of Care
Exclusion criteria
* Any planned non-urogynaecological concomitant procedures * History of previous POP surgery, with the exception of transvaginal approaches without mesh implantation * Previous surgery and/or radiation for urologic, gastrointestinal or gynecologic cancer * History of Crohn's disease * Chronic colitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary safety outcome | up to 42 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
Germany, Switzerland
Outcome results
None listed