Surgical Outcomes of Vaginal Prolapse Repair With Elevate
Sponsor
Larry Sirls (Other)
Overall Status
Completed
CT.gov ID
NCT01190618
Collaborator
(none)
417
1
77
5.4
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Prolift. .
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
The investigators hypothesize that the less invasive Elevate mesh results in a shorter operative time, lower blood loss, complications, postoperative pain and earlier discharge from the hospital.
Study Design
Study Type:
Observational
Actual Enrollment
:
417 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Surgical Outcomes of Vaginal Prolapse Repair With the Elevate Prolapse Repair Kit
Study Start Date
:
Aug 1, 2010
Actual Primary Completion Date
:
Dec 31, 2016
Actual Study Completion Date
:
Dec 31, 2016
Outcome Measures
Primary Outcome Measures
- Comparison of Outcomes [3 Months]
To evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Profift.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Women who have had a vaginal repair with Elevate prolapse repair kit
Exclusion Criteria:
- N/A
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
Sponsors and Collaborators
- Larry Sirls
Investigators
- Principal Investigator: Larry Sirls, MD, William Beaumont Hospitals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Larry Sirls,
Principal Investigator,
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01190618
Other Study ID Numbers:
- 2010-176
First Posted:
Aug 27, 2010
Last Update Posted:
Feb 16, 2017
Last Verified:
Feb 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms: