Comparison of Laparoscopic Cornuostomy and Wedge Resectio... | NCT03064594

Studies
Comparison of Laparoscopic Cornuostomy and Wedge Resection for Interstitial Pregnancy

NCT03064594

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Feb 15, 2019Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Cornual Pregnancy

Interventions

Cornual pregnancy

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

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 9, 2017Actual

Primary Completion Date

Oct 12, 2017Actual

Completion Date

Nov 2, 2018Actual

First Submitted Date

Feb 9, 2017

First Submission Date that Met QC Criteria

Feb 24, 2017

First Posted Date

Feb 27, 2017Actual

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

Feb 12, 2019

Last Update Posted Date

Feb 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

Collaborators

Not provided

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

This retrospective study is to find out the best way to treat patient with cornual pregnancy in the aspect of further pregnancy outcome.

Detailed Description

To find out the best way to treat patient with cornual pregnancy in the aspect of further pregnancy outcome, the investigators compared the outcomes of laparoscopic wedge resection (LWR) and laparoscopic cornuostomy (LC) by the retrospective chart review.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cornuostomy		cornuostomy	Procedure: Cornual pregnancy
wedge resection		wedge resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cornual pregnancy	Procedure	we will get the information of operative time, blood loss and postoperative pregnancy and delivery rate.	cornuostomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pregnancy rate	Comparison of pregnancy rates between the cornuostomy and wedge resection groups	9 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All women with cornual pregnancy who were admitted to the Department of Obstetrics and Gynecology of the Far Eastern Memorial Hospital for laparoscopic surgeries between January 2008 and June 2016 were enrolled

Exclusion Criteria:

The person who was pregnant at the time of the operation
After receiving IVF course of treatment
Patients with uterine horns undergoing open surgery

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

the cases with cornual pregnancy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital		New Taipei City	Banqiao	22060	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D065173	Pregnancy, Cornual

Ancestor Terms

ID	Term
D011271	Pregnancy, Ectopic
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided