A Multi-center Registry Study: The Follow-up the Complications for Trans-vaginal Mesh Surgery

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Pelvic Organ Prolapse

Study type: Observational

Funder types: Other

Identifiers

NCT04025047

JS-1979

Details and patient eligibility

About

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 investigate the incidence of postoperative complications according to the International Urogynecological Association/International Continence Society (IUGA/ICS) complication classification system(the Category- Time-Site(CTS) coding).

Full 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 going to be prospectively collected. The study is designed to report the clinical data，outcomes and complications of transvaginal mesh surgery in China. The information gathered will identify the incidence rate of complications, especially mesh exposure/erosion, in Chinese women and whether published, professional guidelines on POP surgical treatment as well as mesh complications management are being applied appropriately. Findings from this registry may help in knowing the current status of transvaginal mesh use in China as well as identify issues that may affect the surgical outcome and complications occurrence. Based on the registry study, clinical practice on the management of transvaginal mesh implantation including selection patients, pre- and post-operative evaluation and complications surgical database will be established.

The follow-up process starts after patients have completed the operation; thus, our study does not affect patients' choice of surgical method.

Enrollment: 4,147 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

4,147 participants in 1 patient group

Transvaginal mesh

Description:

Patients who undergo pelvic reconstruction surgery using trans-vaginal mesh (commercial mesh kits or self-cut synthesized mesh).