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

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

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) .

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 1530

Contacts and Locations

• Study Contact: Name: Shuo Liang, MD; Phone Number: +86 13718879529; Email: leahleung@foxmail.com
• Study Contact Backup: Name: Lan Zhu, MD; Phone Number: +86 123911714696; Email: zhu_julie@vip.sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Shuo Liang, MD; Phone Number: +86 13718879529; Email: leahleung@foxmail.com
      • Contact: Lan Zhu, MD; Phone Number: +86 13911714696; Email: zhu_julie@vip.sina.com
    • Beijing, Beijing, China, 100037
      • Recruiting
      • First Affiliated Hospital of PLA General Hospital (304)
      • Contact: Ke Niu, MD
      • Contact: Yongxian Lu, MD; Phone Number: +86 13520476024; Email: yongxianlu@sina.com
      • Principal Investigator: Yongxian Lu, MD
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: MD; Phone Number: +86 13609086710; Email: xwzhang81341235@163.com
      • Principal Investigator: Xiaowei Zhang, MD
  • Jiangsu
    • Wuxi, Jiangsu, China, 241002
      • Recruiting
      • Wuxi Obstetrics & Gynecology Hospital
      • Contact: Yijuan Huang
      • Contact: Jian Gong; Phone Number: +86 13812074116; Email: gongjianwx@126.com
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Recruiting
      • Obstetrics & Gynecology Hospital of Fudan University，Shanghai Red House Obstetrics & Gynecology Hospital
      • Contact: Xiaojuan Wang, MD
      • Contact: Keqin Hua, MD; Phone Number: +15921515900; Email: huakeqin@126.com
      • Principal Investigator: Keqin Hua, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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 our participating hospitals but also from other hospital.And the date of surgeries carried is not restricted during the study period.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (ACTUAL): August 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: complications; mesh; tape; pelvic reconstructive surgery; native tissue; Category-time-site (CTS) coding
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: JS-1566-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No