A Multi-center Registry Study: The Follow-up the Complications for Trans-vaginal Mesh Surgery
- Conditions
- Pelvic Organ Prolapse
- Registration Number
- NCT04025047
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 4147
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.
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- Currently pregnant at enrollment;
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- Physically or mentally unable to participate in up to 36 months of follow-up;
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- Desires other surgical management of POP other than trans-vaginal mesh.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence rate of complications 36 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 Outcome Measures
Name Time Method 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.
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.
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.
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.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.
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.
Trial Locations
- Locations (1)
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
🇨🇳Beijing, Beijing, China