Status:
COMPLETED
Permanent Versus Delayed-Absorbable Monofilament Suture
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Hysterectomy
Sacrocolpopexy
Eligibility:
FEMALE
18+ years
Brief Summary
This is an extension study of a prospective, multicenter, randomized, single-blind trial whose purpose is to compare mesh-related complications and effectiveness of pelvic organ prolapse (POP) repair ...
Detailed Description
This is an extension study of a randomized controlled trial that will be conducted at the same 5 clinical sites as the primary study - All subjects who participated in the original randomization and d...
Eligibility Criteria
Inclusion
- Patients who have participated in the PACT Study Trial (Permanent Versus Delayed-absorbable Monofilament Suture for Vaginal Graft Attachment During Minimally-invasive Total Hysterectomy and Sacrocolpopexy: A Randomized Clinical Trial)
Exclusion
- Patient is not willing to sign consent
- Patient does not want to fill-out questionnaires
Key Trial Info
Start Date :
July 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 5 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04506177
Start Date
July 1 2020
End Date
April 5 2023
Last Update
January 26 2024
Active Locations (5)
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1
Augusta University
Augusta, Georgia, United States, 30912
2
Northwestern University
Chicago, Illinois, United States, 60611
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
4
Atrium Health
Charlotte, North Carolina, United States, 28207