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Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

NCT06404931 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-01-17

No results posted yet for this study

Summary

This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery.

They will be randomly assigned in a ratio 1:1:1 to three different groups who will have assigned three different kinds of surgery. In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised. Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors (hADM) for anterior reinforcement and sacrospinous fixation with Anchorsure® device (Neomedic trade mark (TM) International, Spain). Finally, patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone .

Patients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months to evaluate relapses and possible complications.

Conditions

  • Prolapse; Female
  • Prolapse Genital
  • Prolapse Uterovaginal

Interventions

PROCEDURE

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

PROCEDURE

Vaginal hysterectomy plus anterior colporrhaphy

Vaginal hysterectomy plus anterior colporrhaphy

PROCEDURE

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Sponsors & Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    collaborator OTHER

  • Germans Trias i Pujol Hospital

    collaborator OTHER

  • Hospital Arnau de Vilanova

    collaborator OTHER

  • Hospital Mutua de Terrassa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-01-01
Completion
2026-01-01

Countries

  • Spain

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 NCT06404931 on ClinicalTrials.gov