NCT03617211

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) .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,530

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 6, 2018

Status Verified

June 1, 2018

Enrollment Period

5 years

First QC Date

July 12, 2018

Last Update Submit

August 3, 2018

Conditions

Pelvic Organ Prolapse

Keywords

pelvic reconstructive surgerymeshnative tissuetapecomplicationsCategory-time-site (CTS) coding

Outcome Measures

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.

    1-year;3-year;5-year

Secondary Outcomes (2)

  • The distribution of complications after each kind of pelvic reconstructive surgery

    1-year;3-year;5-year

  • The percentage of various pelvic reconstructive surgeries under the same complication classification coding.

    1-year;3-year;5-year

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • \) Patients are inferred to the clinic with the complaint of de novo complications after pelvic reconstructive surgeries with mesh,tape or native tissue.
  • \) 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).
  • \) Both primary and repeated pelvic surgery are included.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

First Affiliated Hospital of PLA General Hospital (304)

Beijing, Beijing Municipality, 100037, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

Wuxi Obstetrics & Gynecology Hospital

Wuxi, Jiangsu, 241002, China

RECRUITING

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

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Lan Zhu, MD

    Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuo Liang, MD

CONTACT

+86 13718879529leahleung@foxmail.com

Lan Zhu, MD

CONTACT

+86 123911714696zhu_julie@vip.sina.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2018

First Posted

August 6, 2018

Study Start

June 1, 2018

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

August 6, 2018

Record last verified: 2018-06

Locations

CN(5)