Risk Factors for Co-existence of Cervical Elongation in U... | NCT02465658

Studies
Risk Factors for Co-existence of Cervical Elongation in Uterine Prolapse

NCT02465658

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Dec 16, 2015Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Pelvic Organ Prolapse

Interventions

Medical records were reviewed.

Countries

Taiwan

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

Dec 2015

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

Mar 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Jun 4, 2015

First Submission Date that Met QC Criteria

Jun 5, 2015

First Posted Date

Jun 8, 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

Dec 15, 2015

Last Update Posted Date

Dec 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 presence of co-existence of cervical elongation in women of uterine prolapse may decrease the patients' satisfaction of uterine-preservation surgery for uterine prolapse, and additional surgery, such as Manchester surgery, may be needed to solve the problem.Thus the aim of this study is to investigate the risk factors of co-existence of cervical elongation in uterine prolapse.

Detailed Description

Purpose:

Thus the aim of this study is to investigate the risk factors of co-existence of cervical elongation in uterine prolapse.

Patients and Methods:

Between January 1994 and October 2014, all women underwent vaginal total hysterectomy in a medical center were enrolled in this study. Medical records were reviewed. Cervical elongation is defined as the presence of cervical length >3.38 cm or cervix to corpus ratio >0.79.

Expected Results:

The investigators will get the risk factors of co-existence of cervical elongation in uterine prolapse, and the result should be helpful for preoperative consultation, especially for uterine-preserving pelvic floor reconstruction surgery.

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

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical records were reviewed.	Other	retrospective study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Factors associated with coexistent cervical elongation in cases with uterine prolapse	Medical record review	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All women with uterine prolapse underwent vaginal total hysterectomy
> 20 years old.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women with uterine prolapse and underwent vaginal total hysterectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ho-Hsiung Lin, MD,PhD	Contact	886-2-23123456	71557	hhlin@ntuh.gov.tw
Sheng-Mou Hsiao	Contact	886-2-89667000	1818	smhsiao2@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics & Gynecology, National Taiwan University Hospital	Recruiting	Taipei	Taiwan	100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse
D014596	Uterine Prolapse

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D014591	Uterine Diseases

Browse Leaves

Not provided

Browse Branches

Not provided