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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03617211

Collaborator

Peking University People's Hospital (Other), Qilu Hospital of Shandong University (Other), Obstetrics & Gynecology Hospital of Fudan University，Shanghai Red House Obstetrics & Gynecology Hospital (Other), Peking University Third Hospital (Other), First Hospitals affiliated to the China PLA General Hospital (Other), Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Other), Tongji Hospital (Other), The First Affiliated Hospital of Guangzhou Medical University (Other), The First Affiliated Hospital with Nanjing Medical University (Other), Wuxi Obsetrics & Gynecology Hospital (Other), Fuzhou General Hospital (Other), The First Affiliated Hospital of Jinan Hospital (Other), Women's Hospital School Of Medicine Zhejiang University (Other), Renmin Hospital of Wuhan University (Other), The Third Hospital Affiliated Zhengzhou University (Other), Shengjing Hospital (Other), General Hospital of Ningxia Medical University (Other), The Second Hospital of Hebei Medical University (Other), Gansu Provincial Maternity and Child-Care Hospital (Other), First Affiliated Hospital of Xinjiang Medical University (Other), Yantai Yuhuangding Hospital，Medical College, Qingdao University (Other), The first Hospital Affiliated To Army Medical University (Other), West China Second University Hospital (Other), Jiangxi Maternal and Child Health Hospital (Other), The Third Affiliated Hospital of Chongqing Medical University (Other), Shanxi Coal Central Hospital (Other)

1,530

Enrollment

Locations

Anticipated Duration (Months)

306

Patients Per Site

4.6

Patients Per Site Per Month

Study Details

Study Description

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) .

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1530 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.
1. 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).
1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of PLA General Hospital (304)	Beijing	Beijing	China	100037
2	Peking Union Medical College Hospital	Beijing	Beijing	China	100730
3	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510120
4	Wuxi Obstetrics & Gynecology Hospital	Wuxi	Jiangsu	China	241002
5	Obstetrics & Gynecology Hospital of Fudan University，Shanghai Red House Obstetrics & Gynecology Hospital	Shanghai	Shanghai	China	200011

Sponsors and Collaborators

Peking Union Medical College Hospital
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 Maternity and Child-Care Hospital
First Affiliated Hospital of Xinjiang Medical University
Yantai Yuhuangding Hospital，Medical College, Qingdao University
The first Hospital Affiliated To Army Medical University
West China Second University Hospital
Jiangxi Maternal and Child Health Hospital
The Third Affiliated Hospital of Chongqing Medical University
Shanxi Coal Central Hospital