A Multi-center Registry Study: The Follow-up the Complications for Trans-vaginal Mesh Surgery

NCT ID: NCT04025047

Last Updated: 2019-07-23

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

RECRUITING

Total Enrollment

4147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-10

Study Completion Date

2026-06-30

Brief Summary

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This is a multi-center, prospective, observational, hospital-based registry of pelvic organ prolapse(POP) patients who having trans-vaginal mesh implantation with 12 month and 36 month follow-up.To investigate the incidence of postoperative complications according to the International Urogynecological Association/International Continence Society (IUGA/ICS) complication classification system(the Category- Time-Site(CTS) coding).

Detailed Description

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Patients who undergo pelvic floor reconstructive surgery with trans-vaginal mesh for the cure of pelvic organ prolapse (POP) between June 2019 and December 2022 from 41 centers across the country are going to be prospectively collected. The study is designed to report the clinical data,outcomes and complications of transvaginal mesh surgery in China. The information gathered will identify the incidence rate of complications, especially mesh exposure/erosion, in Chinese women and whether published, professional guidelines on POP surgical treatment as well as mesh complications management are being applied appropriately. Findings from this registry may help in knowing the current status of transvaginal mesh use in China as well as identify issues that may affect the surgical outcome and complications occurrence. Based on the registry study, clinical practice on the management of transvaginal mesh implantation including selection patients, pre- and post-operative evaluation and complications surgical database will be established.

The follow-up process starts after patients have completed the operation; thus, our study does not affect patients' choice of surgical method.

Conditions

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Pelvic Organ Prolapse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transvaginal mesh

Patients who undergo pelvic reconstruction surgery using trans-vaginal mesh (commercial mesh kits or self-cut synthesized mesh).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1) Patients who undergo the pelvic reconstruction surgery with trans-vaginal mesh; 2) Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation; 3)Willing to participate in 36 months of longitudinal follow-up and able to provide written informed consent. Willing to provide an email address and complete questionnaires on we-chat, either in clinic or elsewhere when they have access to the internet.

Exclusion Criteria

* 1\) Currently pregnant at enrollment;
* 2\) Physically or mentally unable to participate in up to 36 months of follow-up;
* 3\) Desires other surgical management of POP other than trans-vaginal mesh.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

Jiangxi Maternal and Child Health Hospital

OTHER

Sponsor Role collaborator

Fuzhou General Hospital

OTHER

Sponsor Role collaborator

Obstetrics & Gynecology Hospital of Fudan University

OTHER

Sponsor Role collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role collaborator

Affiliated Wuhu Clinical College of Nantong University

UNKNOWN

Sponsor Role collaborator

The Second Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Changsha Hospital for Maternal and Child Health Care

OTHER

Sponsor Role collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Shenzhen People's Hospital

OTHER

Sponsor Role collaborator

Fourth Medical Center of PLA General Hospital

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Second Hospital of Jilin University

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Yantai Yuhuangding Hospital

OTHER

Sponsor Role collaborator

Shanxi Coal Center Hospital

UNKNOWN

Sponsor Role collaborator

Mianyang Central Hospital

OTHER

Sponsor Role collaborator

West China Second University Hospital

OTHER

Sponsor Role collaborator

Chongqing Medical Center for Women and Children

OTHER

Sponsor Role collaborator

Southwest Hospital, China

OTHER

Sponsor Role collaborator

Shaanxi Provincial People's Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

Sponsor Role collaborator

Dalian Maternity and Child Care Hospital

OTHER

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role collaborator

Nanjing Maternity and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Affiliated Renhe Hospital of China Three Gorges University, China

UNKNOWN

Sponsor Role collaborator

Guizhou Provincial People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of the Medical College, Shihezi University,China

UNKNOWN

Sponsor Role collaborator

Yangpu District Central Hospital Affiliated to Tongji University

OTHER

Sponsor Role collaborator

Wuhan Central Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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zhulan

MD, the Chief of General Gynecology Center, the Department of Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

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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Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuo Liang, MD

Role: CONTACT

+8613718879529

Lan Zhu, MD

Role: CONTACT

+8613911714696

Facility Contacts

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Shuo Liang, MD

Role: primary

+86 13718879529

Lan Zhu, MD

Role: backup

+86 13911714696

Other Identifiers

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JS-1979

Identifier Type: -

Identifier Source: org_study_id

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