The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair.
NCT05422209 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310
Last updated 2024-07-03
Summary
This is a prospective randomized controlled study, designed to assess the influence of posterior colporrhaphy and perineoplasty performed simultaneously with mesh-augmented sacrospinal fixation (apical sling) in advanced pelvic organ prolapse repair.
Conditions
- Pelvic Organ Prolapse
Interventions
- PROCEDURE
-
Mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.
Vaginal mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.
- PROCEDURE
-
Mesh-augmented sacrospinal fixation with posterior colporrhaphy.
Vaginal mesh-augmented sacrospinal fixation with posterior colporrhaphy.
Sponsors & Collaborators
-
Saint Petersburg State University, Russia
lead OTHER
Principal Investigators
-
Dmitry Shkarupa, MD, PhD · Saint Petersburg State University, Russia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 80 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-09
- Primary Completion
- 2024-03-09
- Completion
- 2025-05-09
Countries
- Russia
Study Locations
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