Registry of complications after trans-vaginal mesh surgery for pelvic organ prolapse

A Multi-center Registry Study: The Complications After Women Having Pelvic Reconstruction Surgery With Trans-vaginal Mesh

This study is tracking complications in patients who have had trans-vaginal mesh surgery for pelvic organ prolapse to see how often they happen and how well the treatment follows medical guidelines.

Quick facts

• Study type: Observational
• Enrollment: 4147 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04025047 on ClinicalTrials.gov

What this trial studies

This observational registry collects data from patients undergoing trans-vaginal mesh implantation for pelvic organ prolapse across 41 centers in China. It aims to track postoperative complications over 12 and 36 months, utilizing the IUGA/ICS complication classification system. The study will analyze the incidence of complications, such as mesh exposure and erosion, and assess adherence to professional guidelines for surgical treatment and management of complications. The findings will contribute to understanding the current status of trans-vaginal mesh use and inform clinical practices.

Who should consider this trial

Good fit: Ideal candidates are women undergoing pelvic reconstruction surgery with trans-vaginal mesh who can commit to a 36-month follow-up.

Not a fit: Patients who are currently pregnant or prefer alternative surgical management for pelvic organ prolapse will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance patient safety and outcomes by identifying and addressing complications associated with trans-vaginal mesh surgery.

How similar studies have performed: Other studies have shown varying success with similar observational approaches, but this specific registry is novel in its comprehensive focus on complications in the Chinese population.

Eligibility criteria

Inclusion Criteria:

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 Criteria:

* 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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Lan Zhu, MD — Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
• Study coordinator: Shuo Liang, MD

Conditions Pelvic Organ Prolapse; trans-vaginal mesh; pelvic reconstruction surgery; complications; the CTS coding system