NCT00581412

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

January 11, 2010

Status Verified

January 1, 2010

Enrollment Period

7 months

First QC Date

December 20, 2007

Last Update Submit

January 7, 2010

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapseComposite biologic/synthetic graftAbdominal sacrocolpopexy

Outcome Measures

Primary Outcomes (1)

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

    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.

    To the point of graft erosion after abdominal sacrocolpopexy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent abdominal sacrocolpopexy

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Karen L Noblett, M.D.

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 27, 2007

Study Start

September 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

January 11, 2010

Record last verified: 2010-01

Locations

US(1)