Actively Recruiting
A Multi-center Registry Study: The Complications After Women Having Pelvic Reconstruction Surgery With Trans-vaginal Mesh
Led by Peking Union Medical College Hospital · Updated on 2019-07-23
4147
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
Q
Qilu Hospital of Shandong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are collecting information from women who have pelvic organ prolapse (POP) and are treated with trans-vaginal mesh surgery. This hospital-based, multi-center study aims to observe and record postoperative complications, especially mesh exposure or erosion, using an international classification system. The study includes patients from 41 centers across China and will track outcomes over 12 and 36 months after surgery to understand current practices and complication rates in this population. Participants receive pelvic floor reconstructive surgery using either commercial mesh kits or self-cut synthesized mesh through the vagina. The study observes these patients without altering their treatment choice, focusing on how the surgery is performed and its results. Follow-up assessments occur at various points up to three years after surgery, including evaluations at 6 weeks, 3 months, 1 year, and annually to monitor anatomical cure rates and complications. During the study, participants will complete questionnaires about their pelvic health and sexual function using tools like POP-Q, PGI-I, PFDI-20, PFIQ-7, and PISQ-12 at scheduled visits. Researchers will review complication rates at 12 and 36 months while examining changes in symptoms and quality of life. Participants are expected to provide contact information for follow-up and complete online surveys through WeChat. The total follow-up lasts for 36 months after surgery, with ongoing data collection to better understand long-term outcomes and management of trans-vaginal mesh procedures.
CONDITIONS
Brief Title
A Multi-center Registry Study: The Follow-up the Complications for Trans-vaginal Mesh Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who undergo pelvic reconstruction surgery with trans-vaginal mesh
- Mentally able to understand the nature, aims, or possible consequences of the study
- Willing to participate in 36 months of follow-up and able to provide written informed consent
- Willing to provide an email address and complete questionnaires on WeChat, either in clinic or elsewhere when they have internet access
You will not qualify if you...
- Currently pregnant at enrollment
- Physically or mentally unable to participate in up to 36 months of follow-up
- Desires other surgical management of pelvic organ prolapse besides trans-vaginal mesh
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Day of surgery plus hospitalization period
Participants undergo pelvic reconstruction surgery with trans-vaginal mesh and receive immediate post-operative care.
1 surgical visit (in-person)
Duration - Up to 36 months postoperatively
Participants are followed for up to 36 months after surgery to monitor complications, anatomical outcomes, and quality of life through scheduled assessments.
Visits at 6 weeks, 3 months, 1 year, and annually up to 3 years postoperatively
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
S
Shuo Liang, MD
L
Lan Zhu, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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