Status:
RECRUITING
A Multi-center Registry Study: The Follow-up the Complications for Trans-vaginal Mesh Surgery
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Qilu Hospital of Shandong University
The First Affiliated Hospital of Nanchang University
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Brief Summary
This is a multi-center, prospective, observational, hospital-based registry of pelvic organ prolapse(POP) patients who having trans-vaginal mesh implantation with 12 month and 36 month follow-up.To in...
Detailed Description
Patients who undergo pelvic floor reconstructive surgery with trans-vaginal mesh for the cure of pelvic organ prolapse (POP) between June 2019 and December 2022 from 41 centers across the country are ...
Eligibility Criteria
Inclusion
- 1） Patients who undergo the pelvic reconstruction surgery with trans-vaginal mesh; 2) Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation; 3）Willing to participate in 36 months of longitudinal follow-up and able to provide written informed consent. Willing to provide an email address and complete questionnaires on we-chat, either in clinic or elsewhere when they have access to the internet.
Exclusion
- 1\) Currently pregnant at enrollment;
- 2\) Physically or mentally unable to participate in up to 36 months of follow-up;
- 3\) Desires other surgical management of POP other than trans-vaginal mesh.
Key Trial Info
Start Date :
April 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
4147 Patients enrolled
Trial Details
Trial ID
NCT04025047
Start Date
April 10 2019
End Date
June 1 2026
Last Update
July 23 2019
Active Locations (1)
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1
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, Beijing Municipality, China, 100730