Comparing biological and synthetic mesh in pelvic prolapse surgery
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery: a Multicentre, Phase 11-111, Partially Randomised Patient Preference Trial
This study is testing whether a new biological mesh works better than the standard synthetic mesh in surgeries for pelvic prolapse to help doctors make better choices for their patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Meander Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Amersfoort, Utrecht) |
| Trial ID | NCT06430931 on ClinicalTrials.gov |
What this trial studies
This prospective study evaluates the effectiveness of OviTex 1S, a biological mesh, against the standard polypropylene mesh in minimal-invasive ventral mesh rectopexy (VMR) and sacrocolporectopexy (SCR) procedures for pelvic prolapse. The study addresses the ongoing debate regarding the choice of mesh material, especially in light of recent FDA regulations affecting synthetic mesh. Participants will be randomly assigned to receive either type of mesh, and outcomes will be assessed for recurrence rates and graft-related complications. The goal is to provide high-quality evidence to guide clinical decisions in pelvic floor surgery.
Who should consider this trial
Good fit: Ideal candidates include patients indicated for VMR or SCR who have been counseled on their options and can provide informed consent.
Not a fit: Patients with a history of pelvic radiation therapy or those who have previously had pelvic floor meshes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing pelvic prolapse surgery.
How similar studies have performed: While there is ongoing debate regarding mesh types, high-quality evidence comparing biological and synthetic meshes is currently lacking, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amersfoort, Utrecht
- Meander Medisch Centrum — Amersfoort, Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Esther Consten, Prof.dr — Meander Medisch Centrum
- Study coordinator: Marije Boom, drs.
- Email: ma.boom@meandermc.nl
- Phone: + 31 33 850 1716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.