Pelvic Organ Prolapse
Conditions
Keywords
pelvic reconstructive surgery, mesh, native tissue, tape, complications, Category-time-site (CTS) coding
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.
Interventions
None listed
Sponsors
Peking University People's Hospital
Qilu Hospital of Shandong University
Obstetrics & Gynecology Hospital of Fudan University，Shanghai Red House Obstetrics & Gynecology Hospital
Peking University Third Hospital
First Hospitals affiliated to the China PLA General Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Tongji Hospital
The First Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital with Nanjing Medical University
Wuxi Obsetrics & Gynecology Hospital
Fuzhou General Hospital
The First Affiliated Hospital of Jinan Hospital
Women's Hospital School Of Medicine Zhejiang University
Renmin Hospital of Wuhan University
The Third Hospital Affiliated Zhengzhou University
Shengjing Hospital
General Hospital of Ningxia Medical University
The Second Hospital of Hebei Medical University
Gansu Provincial Maternal and Child Health Care Hospital
First Affiliated Hospital of Xinjiang Medical University
Yantai Yuhuangding Hospital，Medical College, Qingdao University
Southwest Hospital, China
West China Second University Hospital
Jiangxi Maternal and Child Health Hospital
Chongqing Medical University
Shanxi Coal Central Hospital
Peking Union Medical College Hospital
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactShuo Liang, MD
Backup ContactLan Zhu, MD
Outcome results
None listed