The Follow-up of Mesh/Native Tissue Complications Study(Part II)
- Conditions
- Pelvic Organ Prolapse
- Registration Number
- NCT03617211
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1530
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- Patients are inferred to the clinic with the complaint of de novo complications after pelvic reconstructive surgeries with mesh,tape or native tissue.
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- 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).
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- Both primary and repeated pelvic surgery are included.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The frequency and ratio of different postoperative complications 1-year;3-year;5-year 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.
- Secondary Outcome Measures
Name Time Method The distribution of complications after each kind of pelvic reconstructive surgery 1-year;3-year;5-year 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, %).
The percentage of various pelvic reconstructive surgeries under the same complication classification coding. 1-year;3-year;5-year Analyze and calculate the percentage of different surgical method when they present the complication with the same IUGA-ICS coding.
Trial Locations
- Locations (5)
Obstetrics & Gynecology Hospital of Fudan University，Shanghai Red House Obstetrics & Gynecology Hospital
🇨🇳Shanghai, Shanghai, China
First Affiliated Hospital of PLA General Hospital (304)
🇨🇳Beijing, Beijing, China
Wuxi Obstetrics & Gynecology Hospital
🇨🇳Wuxi, Jiangsu, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China