The Follow-up of Mesh/Native Tissue Complications Study(Part II)

Study Overview
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Brief Summary
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To study the incidence and distribution of complications after different pelvic reconstruction surgeries (mesh/native tissue) in multi-centers. The investigators aimed to report and summarize the postoperative complications diagnosed in the prior 1 year, 3 years and 5 years respectively, according to the International Urogynecological AssociationInternational Continence Society(IUGA-ICS) Complication Classification Coding(Category-Time-Site coding system) .

Detailed Description
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Patients are inferred to 27 tertiary hospitals with the complaint of de novo complications after pelvic reconstructive surgeries using mesh, tape and native tissue between June 2018 and June 2023. The subjects include patients who accept treatment not only at 27 participating hospitals but also from other hospital. And the date of surgeries carried is not restricted in the study period. This is a study of real world. The researchers focus to investigate the incidence of complications in clinical practice.

Official Title
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A Multi-center Study: The Follow-up of Complications for Women Having Pelvic Reconstruction Surgery With Mesh/Native Tissue(Part II).

Conditions
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Pelvic Organ Prolapse

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Patients are inferred to the clinic with the complaint of de novo complications after pelvic reconstructive surgeries with mesh,tape or native tissue. 2) Pelvic reconstructive surgeries include but not limited to open/laparoscopic sacrocolpopexy (Y-shape tape/self-cut synthesized mesh), anterior, apical, posterior or total pelvic reconstruction with trans-vaginal mesh(commercial mesh kits or self-cut synthesized mesh), repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation, the Lefort operation) and as well as anti-urinary incontinence surgeries(tension-free vaginal tape). 3) Both primary and repeated pelvic surgery are included. Exclusion Criteria: If the same patient who developed complications after pelvic floor reconstructive surgeries has been diagnosed and reported in 27 participating hospitals, and again treated for the same code complication in other 26 hospitals, she will be ruled out.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency and ratio of different postoperative complications | Calculate the frequency(reported in number of cases) and ratio(reported in percentage, %) of different complications reported from 27 tertiary hospitals in the past year or 3 years or 5 years, respectively.The complications occurred after pelvic reconstructive surgeries, especially mesh/native tissue related,are classified by IUGA-ICS CTS(category-time-site)coding system. | 1-year;3-year;5-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distribution of complications after each kind of pelvic reconstructive surgery | For each kind of surgery,the distribution of different postoperative complications, classified by the IUGA-ICS coding system, is expressed in frequency (reported in number of cases) and ratio(reported in percentage, %). | 1-year;3-year;5-year | 
| The percentage of various pelvic reconstructive surgeries under the same complication classification coding. | Analyze and calculate the percentage of different surgical method when they present the complication with the same IUGA-ICS coding. | 1-year;3-year;5-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic reconstructive surgery, mesh, native tissue, tape, complications, Category-time-site (CTS) coding