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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04025047

Enrollment

4147

Registered

2019-07-18

Start date

2019-04-10

Completion date

2026-06-30

Last updated

2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

trans-vaginal mesh, pelvic reconstruction surgery, complications, the CTS(category-time-site) coding system

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 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).

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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
The incidence rate of complications	12 months postoperatively	Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society（IUGA-ICS）Complication Classification Coding(Category-Time-Site coding system).

Secondary

Measure	Time frame	Description
Change from preoperative scores of POP-Q(Pelvic organ prolapse quantitation) at each follow-up	Preoperatively; At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively	POP-Q is used for evaluation the severity(staging) of prolapse by pelvic examination preoperatively and postoperatively. The score is reported in cm. The changes from baseline scores at 6 weeks, 3 months, 1 year and up to 3 years postoperatively are respectively compared.
Patient global impression of improvement (PGI-I)	At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively	The Chinese-version validated questionnaire PGI-I is used for assessing patients' subjective satisfaction to the pelvic floor reconstructions surgery. The PGI-I score ranges from 0\ 7.
Anatomical cure rate in treated compartment of pelvic reconstructive surgery with trans-vaginal mesh	6 weeks, 3 months and each year, up to 3-year postoperatively	The percentage of patients who reach the anatomical success criteria at each time point（6 weeks, 3 months and each year, up to 3-year postoperatively）.The anatomical success is defined by a composite outcome that includes absence of vaginal bulge symptoms, absence of vaginal descent beyond the hymen and the absence of retreatment.
Changes in Pelvic Floor Impact Questionnaire-7（PFIQ-7）scores	Preoperatively; At 1 year and 3 year postoperatively	The Chinese-version validated questionnaire Pelvic Floor Impact Questionnaire-7 \[PFIQ-7\] is to evaluate the impact on quality of life.
Changes in sexual function and measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire（PISQ-12）scores	Preoperatively; At 1 year and 3 year postoperatively	The Chinese-version validated questionnaire Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores （PISQ-12） is to evaluate the impact on sexual function.
Changes in Pelvic Floor Distress Inventory-20 (PFDI-20) scores	Preoperatively; At 1 year and 3 year postoperatively	The Chinese-version validated questionnaire Pelvic Floor Distress Inventory-short Form 20 scores \[PFDI-20\] is to evaluate the impact on pelvic floor function.

Countries

China

Contacts

Primary ContactShuo Liang, MD

leahleung@foxmail.com+8613718879529

Backup ContactLan Zhu, MD

zhu_julie@vip.sina.com+8613911714696

Outcome results