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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03617211
• Other study ID #: JS-1566-2
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: December 2023

Study information

• Verified date: June 2018
• Source: Peking Union Medical College Hospital
• Contact: Shuo Liang, MD
• Phone: +86 13718879529
• Email: leahleung[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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) .

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 information / eligibility

• Status: Recruiting
• Enrollment: 1530
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
China	First Affiliated Hospital of PLA General Hospital (304)	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Obstetrics & Gynecology Hospital of Fudan University,Shanghai Red House Obstetrics & Gynecology Hospital	Shanghai	Shanghai
China	Wuxi Obstetrics & Gynecology Hospital	Wuxi	Jiangsu

Sponsors (27)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

First Affiliated Hospital of PLA General Hospital (304), First Affiliated Hospital of Xinjiang Medical University, Fuzhou General Hospital, Gansu Provincial Maternity and Child-care Hospital, General Hospital of Ningxia Medical University, Jiangxi Maternal and Child Health Hospital, Obstetrics & Gynecology Hospital of Fudan University,Shanghai Red House Obstetrics & Gynecology Hospital, Peking University Third Hospital, People's Hospital of Peking University, Qilu Hospital of Shandong University, Renmin Hospital of Wuhan University, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, Shanxi Coal Central Hospital, Shengjing Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Jinan Hospital, The First Affiliated Hospital with Nanjing Medical University, The first Hospital Affiliated To Army Medical University, The Second Hospital of Hebei Medical University, The Third Affiliated Hospital of Chongqing Medical University, The Third Hospital Affiliated Zhengzhou University, Tongji Hospital of Tongji University, West China Second University Hospital, Women's Hospital School Of Medicine Zhejiang University, Wuxi Obsetrics & Gynecology Hospital, Yantai Yuhuangding Hospital,Medical College, Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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