Trials
Search / Trial NCT06430931

Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery

Launched by MEANDER MEDICAL CENTER · May 21, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

Prolapse Abdominal Prolapse Surgery Biological Mesh Ovi Tex Vmr Sacrocolporectopexy

ClinConnect Summary

This clinical trial is studying the effectiveness of a new type of mesh called OviTex 1S compared to the standard polypropylene mesh used in pelvic floor surgeries for conditions like prolapse. Prolapse occurs when pelvic organs, such as the bladder or uterus, drop from their normal position. The trial aims to find out which mesh works better for patients undergoing specific surgical procedures for these conditions.

To participate in the trial, you need to be between 65 and 74 years old and have been recommended for surgery involving pelvic prolapse. It's important that you have discussed the treatment options with your doctor and understand the differences between the two types of mesh. If you decide to join, you will be randomly assigned to receive either the OviTex or the standard mesh, and you’ll need to give written consent. The trial is currently recruiting participants, and anyone interested should be aware that those with certain medical histories, like previous pelvic surgeries or allergies to specific materials, may not be eligible. By participating, you could help contribute to important research that may improve surgical outcomes for many patients in the future.

Gender

ALL

Eligibility 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

Trial Officials

Esther Consten, Prof.dr

Principal Investigator

Meander Medisch Centrum

About Meander Medical Center

Meander Medical Center is a leading healthcare institution dedicated to advancing medical research and improving patient care through innovative clinical trials. With a commitment to excellence, the center collaborates with a diverse network of healthcare professionals and researchers to explore cutting-edge therapies and treatment modalities. By prioritizing patient safety and ethical standards, Meander Medical Center aims to contribute valuable insights to the medical community, ultimately enhancing the quality of life for individuals through evidence-based practices and comprehensive clinical investigations.

Locations

Amersfoort, Utrecht, Netherlands

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0