The Follow-up of Mesh/Native Tissue Complications Study(P... | NCT03617211

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

NCT03617211

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Aug 6, 2018Actual

Enrollment

1,530Estimated

Phase

Not provided

Conditions

Pelvic Organ Prolapse

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Jun 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Jul 12, 2018

First Submission Date that Met QC Criteria

Aug 3, 2018

First Posted Date

Aug 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2018

Last Update Posted Date

Aug 6, 2018Actual

Name	Class
Peking University People's Hospital	OTHER
Qilu Hospital of Shandong University	OTHER
Obstetrics & Gynecology Hospital of Fudan University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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) .

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,530Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shuo Liang, MD	Contact	+86 13718879529		leahleung@foxmail.com
Lan Zhu, MD	Contact	+86 123911714696		zhu_julie@vip.sina.com

Overall Officials

Name	Affiliation	Role
Lan Zhu, MD	Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of PLA General Hospital (304)	Recruiting	Beijing	Beijing Municipality	100037	China

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms