Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMeander Medical Center

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

Mentally incompetent patients (unable to fulfil questionnaires).

Allergy to ovine rumen.

A medical history of pelvic radiation therapy.

Scheduled for a redo-rectopexy.

Trial design

Treatments tested in this trial

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

Treatment groups

184 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Meander Medical Center

Lead sponsor

Health Holland

Collaborator