CClinicalTrials.gg
Status unknownNCT03617211Updated Aug 6, 2018

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

An observational study in Pelvic Organ Prolapse, sponsored by Peking Union Medical College Hospital. Status unknown at 5 sites in China. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-06.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
1,530
Ages
18 Years to 80 Years
Sex
Female
01

Study 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) .

Read the 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.

02

Conditions studied

  • Pelvic Organ Prolapse

Keywords

  • pelvic reconstructive surgery
  • mesh
  • native tissue
  • tape
  • complications
  • Category-time-site (CTS) coding
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In context

Prolapse

676 studies on the registry are indexed under Prolapse; 79 are open to participants now.

This study's planned enrollment of 1,530 is above the median of 126 across 222 observational studies indexed under Prolapse.

Browse Prolapse studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
1,530 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1-year;3-year;5-year

Secondary outcomes

  1. 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, %).

    Time frame: 1-year;3-year;5-year

  2. 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.

    Time frame: 1-year;3-year;5-year

07

Study locations

5 of 5 sites recruiting
  • First Affiliated Hospital of PLA General Hospital (304)
    Beijing, Beijing 100037, China
    • Ke Niu, MD · Contact
    • Yongxian Lu, MD · Contact · yongxianlu@sina.com · +86 13520476024
    • Yongxian Lu, MD · Principal investigator
    Recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    Recruiting
  • The First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510120, China
    Recruiting
  • Wuxi Obstetrics & Gynecology Hospital
    Wuxi, Jiangsu 241002, China
    • Yijuan Huang · Contact
    • Jian Gong · Contact · gongjianwx@126.com · +86 13812074116
    • Jian Gong · Principal investigator
    Recruiting
  • Obstetrics & Gynecology Hospital of Fudan University,Shanghai Red House Obstetrics & Gynecology Hospital
    Shanghai, Shanghai 200011, China
    • Xiaojuan Wang, MD · Contact
    • Keqin Hua, MD · Contact · huakeqin@126.com · +15921515900
    • Keqin Hua, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03617211
Lead sponsor
Peking Union Medical College Hospital
Collaborators
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
Responsible party
Sponsor
First posted
Aug 6, 2018
Start date
Jun 1, 2018
Primary completion
Jun 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Aug 6, 2018

Study contacts

Shuo Liang, MD
Contact
leahleung@foxmail.com
+86 13718879529
Lan Zhu, MD
Contact
zhu_julie@vip.sina.com
+86 123911714696
Lan Zhu, MD
principal investigator · Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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