Prospective Data Collection of Patients Undergoing Gyneco... | NCT02405936

Studies
Prospective Data Collection of Patients Undergoing Gynecologic Surgery

NCT02405936

Sponsor

Kangbuk Samsung Hospital

Status

Unknown status

Last Update Posted

Apr 3, 2019Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Disease (or Disorder); Gynecological

Interventions

Gynecologic surgery

Countries

South Korea

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

Apr 2019

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

Mar 2015

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Mar 28, 2015

First Submission Date that Met QC Criteria

Mar 28, 2015

First Posted Date

Apr 1, 2015Estimated

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

Apr 1, 2019

Last Update Posted Date

Apr 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The aim of this prospective study is to collect data on patients undergoing gynecologic surgery at Kangbuk Samsung Hospital.

Detailed Description

The aim of this prospective study is to collect data on patients undergoing gynecologic surgery at Kangbuk Samsung Hospital. If patients agree to participate in this clinical trial, patient's data (such as age, body mass index, preoperative findings, laboratory findings, radiologic findings, operative findings, pathologic findings, postoperative findings) will be collected in a research database. The research database will be updated, every 6 month, to include data on patient's disease outcome and follow-up care. Although most data will be collected form the medical record, patient may agin be contacted so that researchers can collection some data if it is not in the medical record.

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

3,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gynecologic surgery	Procedure	The researchers prospectively will collect data on all patients undergoing gynecologic surgery at Kangbuk Samsung Hospital since March, 2015.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prospective data collection of patients undergoing gynecologic surgery		10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients undergoing gynecologic surgery at Kangbuk Samsung Hospital since March, 2015

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All patients undergoing gynecologic surgery at Kangbuk Samsung Hospital since March, 2015

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Taejong Song, MD PhD	Contact	82-2-2001-2582		taejong.song@gmail.com

Overall Officials

Name	Affiliation	Role
Taejong Song, MD PhD	Kangbuk Samsung Hospital, Seoul, Republic of Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kangbuk Samsung Hospital	Recruiting	Seoul		110-746	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D004194	Disease

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013509	Gynecologic Surgical Procedures

Ancestor Terms

ID	Term
D013519	Urogenital Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided