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

NCT ID: NCT03617211

Last Updated: 2018-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1530 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Pelvic Organ Prolapse

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Obstetrics & Gynecology Hospital of Fudan University,Shanghai Red House Obstetrics & Gynecology Hospital

UNKNOWN

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role collaborator

First Hospitals affiliated to the China PLA General Hospital

OTHER_GOV

Sponsor Role collaborator

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Wuxi Obsetrics & Gynecology Hospital

UNKNOWN

Sponsor Role collaborator

Fuzhou General Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Jinan Hospital

UNKNOWN

Sponsor Role collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

The Third Hospital Affiliated Zhengzhou University

UNKNOWN

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

General Hospital of Ningxia Medical University

OTHER

Sponsor Role collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Gansu Provincial Maternal and Child Health Care Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

Yantai Yuhuangding Hospital,Medical College, Qingdao University

UNKNOWN

Sponsor Role collaborator

Southwest Hospital, China

OTHER

Sponsor Role collaborator

West China Second University Hospital

OTHER

Sponsor Role collaborator

Jiangxi Maternal and Child Health Hospital

OTHER

Sponsor Role collaborator

Chongqing Medical University

OTHER

Sponsor Role collaborator

Shanxi Coal Central Hospital

UNKNOWN

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lan Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Locations

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First Affiliated Hospital of PLA General Hospital (304)

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Wuxi Obstetrics & Gynecology Hospital

Wuxi, Jiangsu, China

Site Status RECRUITING

Obstetrics & Gynecology Hospital of Fudan University,Shanghai Red House Obstetrics & Gynecology Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuo Liang, MD

Role: CONTACT

+86 13718879529

Lan Zhu, MD

Role: CONTACT

+86 123911714696

Facility Contacts

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Ke Niu, MD

Role: primary

Yongxian Lu, MD

Role: backup

+86 13520476024

Shuo Liang, MD

Role: primary

+86 13718879529

Lan Zhu, MD

Role: backup

+86 13911714696

MD

Role: primary

+86 13609086710

Yijuan Huang

Role: primary

Jian Gong

Role: backup

+86 13812074116

Xiaojuan Wang, MD

Role: primary

Keqin Hua, MD

Role: backup

+15921515900

Other Identifiers

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JS-1566-2

Identifier Type: -

Identifier Source: org_study_id

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