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Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery

RecruitingNAAges 18 Years - anyAllMeander Medical Center
NCT06430931 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective study aims to assess the efficacy of the OviTex 1S permanent mesh in pelvic floor surgery in comparison with the current standard polypropylene mesh.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Indication for VMR or SCR set by the treating surgeon/gynecologist in accordance to the current guidelines on rectal and pelvic prolapse; * Counselled for therapeutic options and given informed consent for VMR or SCR; * Counselled for different types of mesh (OviTex or Prolene) and randomisation; * Written informed consent for randomisation, OviTex implant or Prolene; * Written informed consent for observational data collection. Exclusion Criteria: * Mentally incompetent patients (unable to fulfil questionnaires). * Allergy to ovine rumen. * A medical history of pelvic radiation therapy. * Scheduled for a redo-rectopexy. * A medical history of previously implanted pelvic floor meshes or native tissue. * Language barrier
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What it tests

  • Minimal invasive abdominal prolapse surgery using Polypropylene mesh
  • Minimal invasive abdominal prolapse surgery using OviTex 1S permanent mesh
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Where

1 site
Meander Medisch Centrum
Amersfoort, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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