MedTrace Logo

Cost-effectiveness Comparison Between Vaginal Versus Robotic Mesh Surgery for Apical Prolapse: Prospective, Cohort Study

NCT03878056 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 147

Last updated 2022-04-08

No results posted yet for this study

Summary

Cost-effectiveness, safety, outcomes and diagnostic development in advanced apical female genital prolapse reconstructive surgery by vaginal and robotic-assisted mesh surgery.

A multicenter, prospective, parallel, cohort, comparative study between the vaginal and robotic-assisted mesh surgery including 200 patients.

Conditions

  • Prolapse; Female

Interventions

DEVICE

Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific

Apical prolapse reconstructive surgery by Transvaginal mesh vs Robotic sacral colpopexy

Sponsors & Collaborators

Principal Investigators

  • Edward Morcos, MD, PhD · Karolinska Institutet Danderyds Sjukhus (KIDS)

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-12-31
Completion
2021-11-30
FDA Device
Yes

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03878056 on ClinicalTrials.gov