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The Influence of Using Vascularized Vaginal Flap on the Efficacy of Mesh-augmented Sacrospinous Hysteropexy

NCT06494982 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-10

No results posted yet for this study

Summary

This is a prospective randomized controlled trial designed to compare the effectiveness and safety of two methods of pelvic floor reconstruction in patients with pelvic organ prolapse (POP): sacrospinous hysteropexy (SSHP) with synthetic mesh, vascularized anterior vaginal wall flap, anterior colporrhaphy, and sacrospinous hysteropexy with synthetic mesh. , anterior colporrhaphy, as well as the impact of surgery on quality of life.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy

Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy

PROCEDURE

Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy

Sacrospinous hysteropexy with the synthetic mesh and anterior 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
2024-05-01
Primary Completion
2024-10-01
Completion
2025-10-01

Countries

  • Russia

Study Locations

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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 NCT06494982 on ClinicalTrials.gov