Actively Recruiting

Age: 18Years +
FEMALE
ID04025047

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Surgery and Immediate Post-operative Care

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)

Post-operative Follow-up

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

Loading map...

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

Similar Trials

Accelerometer Measured Early Recovery After Prolapse Surgery...

Pelvic Organ Prolapse

Actively Recruiting

7 locations

Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy...

Pelvic Organ Prolapse

Actively Recruiting

5 locations

Centered Surgery - Preoperative Counseling and Patient Satis...

Pelvic Organ Prolapse

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here