RecruitingNot Applicable

Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery

Netherlands184 participantsStarted 2023-12-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Main study parameter/endpoint phase II: rate of complications

Timeframe: 90days postoperative

Main study parameter/endpoint phase ll: number of participants with post-operative morbidity

Timeframe: 90days postoperative

Main study parameter/endpoint phase Ill: Pelvic Floor Distress lnventory-20 score (PFDl-20)

Timeframe: 24 months postoperative

Trial details

NCT IDNCT06430931

SponsorMeander Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-01

Contact for this trial

Marije Boom, drs.

+ 31 33 850 1716 ma.boom@meandermc.nl

View on ClinicalTrials.gov More Colorectal Disorders trials