Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates

University of California Irvine (UCI)

Status

Completed

Conditions

Pelvic Organ Prolapse

Study type

Observational

Funder types

Other

Identifiers

NCT00581412

2007-5858

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria