Transvaginal Human Acellular Dermal Matrix and Sacrospinous Fixation for Anterior and Apical Prolapse Treatment in Patients With Hiatal Ballooning or Levator Ani Injury: a Randomized Pilot Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Women with symptomatic POP with indication of vaginal surgery.

• Women with hiatal ballooning or levator ani injury evaluated by 3D pelvic floor ultrasound.

• Women ≥18 years old.

• Women wishing to complete a 36-month follow-up.

• Understand and accept the study procedures and sign the informed consent.

Locations
Other Locations
Spain
Hospital Mutua de Terrassa
RECRUITING
Terrassa
Contact Information
Primary
Gerard Molina
+34937365050
Backup
Pilar Arcusa
+34937365050
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 90
Treatments
Sham_comparator: Vaginal hysterectomy plus anterior colporrhaphy
Vaginal hysterectomy plus anterior colporrhaphy
Sham_comparator: Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
Experimental: Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device
Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device
Related Therapeutic Areas
Sponsors
Collaborators: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Arnau de Vilanova, Germans Trias i Pujol Hospital
Leads: Hospital Mutua de Terrassa

This content was sourced from clinicaltrials.gov