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Completed

NCT Number: NCT00581412

Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California, Irvine Medical Center

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent abdominal sacrocolpopexy with Drs. Noblett and Lane from 2001 to present

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. The erosion rates of composite biologic/syntheric grafts and synthetic-only grafts will be compared.

    Time frame: To the point of graft erosion after abdominal sacrocolpopexy

Secondary outcomes

  1. Cost effectiveness will be examined by comparing the price of a composite graft to the cost of re-operation due to erosion of a synthetic-only graft.

    Time frame: To the point of graft erosion after abdominal sacrocolpopexy

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 27, 2007
Registry last updated
Jan 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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