RecruitingNot ApplicableNCT06430931

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

Sponsor

Meander Medical Center

Enrollment

184 participants

Start Date

Dec 6, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal Disorders Prolapse Prolapse; Cervix Prolapse Rectal Prolapse Genital Prolapse Pelvic Rectocele Prolapse Uterus Cystocele Enterocele Prolapse Bladder

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Minimal invasive abdominal prolapse surgery using OviTex 1S permanent mesh and a procedure called Minimal invasive abdominal prolapse surgery using Polypropylene mesh for people with colorectal disorders, cystocele, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMinimal invasive abdominal prolapse surgery using Polypropylene mesh

All procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA).

PROCEDUREMinimal invasive abdominal prolapse surgery using OviTex 1S permanent mesh

All procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA).

Locations(1)

Meander Medisch Centrum

Amersfoort, Utrecht, Netherlands

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NCT06430931

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