Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates

Pelvic Organ Prolapse Clinical Trial

Official title:

Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581412
• Other study ID #: 2007-5858
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: January 7, 2010
• Start date: September 2007
• Est. completion date: April 2008

Study information

• Verified date: January 2010
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The erosion rates of composite biologic/syntheric grafts and synthetic-only grafts will be compared.		To the point of graft erosion after abdominal sacrocolpopexy	No
Secondary	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.		To the point of graft erosion after abdominal sacrocolpopexy	No