Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery: a Multicentre, Phase 11-111, Partially Randomised Patient Preference Trial
Meander Medical Center
184 participants
Dec 6, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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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Interventions
All procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA).
All procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA).
Locations(1)
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NCT06430931