Cornual Wedge Resection Outcome | NCT03974841

Studies
Cornual Wedge Resection Outcome

NCT03974841

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Jun 5, 2019Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Ectopic Pregnancy
Laparoscopic
Cornual Pregnancy

Interventions

laparoscopic cornual resection

Countries

Turkey (Türkiye)

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 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

Jan 1, 2016Actual

Primary Completion Date

Jan 1, 2019Actual

Completion Date

Jan 1, 2019Actual

First Submitted Date

Jun 3, 2019

First Submission Date that Met QC Criteria

Jun 3, 2019

First Posted Date

Jun 5, 2019Actual

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

Jun 3, 2019

Last Update Posted Date

Jun 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pınar Kadirogulları, principal investigator, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Cornual pregnancy is a rare form of ectopic pregnancy that accounts for 2% to 4% of ectopic pregnancies, with a mortality rate between 2.0% and 2.5%. Traditionally, interstitial pregnancies were treated by laparotomy with cornial resection or hysterectomy. However, nowadays, increasingly interstitial pregnancies are treated by laparoscopic cranial resection.

Although this technique can potentially protect the fertility of the patient, it carries a serious risk of bleeding and requires a surgical experience.

Detailed Description

Not provided

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

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laparoscopic cornual resection	Procedure	patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operation time	The duration of surgery of patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy	surgery from start to end
amount of bleeding	The amount of hemorrhage in patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cornual ectopic pregnancy
Patients undergoing laparoscopic cornual wedge resection

Exclusion Criteria:

medical treatment area due to cornual pregnancy
laparotomy
conservatively managed patients

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

postoperative results of patients who underwent laparoscopic cornual resection for cornual ectopic pregnancy, Patients forming the study group will be operated in the center for the last 3 years.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanuni Sultan Süleyman Training and Research Hospital		Istanbul		33404	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D011271	Pregnancy, Ectopic
D065173	Pregnancy, Cornual

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided