NCT00581412

Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine whether the use of a composite biologic/synthetic graft during abdominal sacrocolpopexy leads to a lower rate of erosion while maintaining durability.

Detailed description

This study will examine the erosion rate of a composite graft that is being used during abdominal sacrocolpopexy. The composite graft is composed of a dual layer of biological and syntheric material. Biological grafts have the advantage of significantly reducing erosion rates, but the longevity of biologic graft is uncertain. On the other hand, synthetic grafts have the advantage in that they are durable, but have higher erosion rates through the vagina and require re-operation in a small percentage of patients. This study will look at whether or not the use of a composite greaft carries the advantages of both types of materials and leads to decreased rates of erosion while maintaining longevity. The cost effectiveness of this new type of graft will also be reviewed since the disavantage of utilizing both the synthetic and biologic graft is that it will increase the cost.

Conditions

• Pelvic Organ Prolapse

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-12-27
• Last updated: 2010-01-11

Locations

1 site across 1 country: United States