The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube

NCT ID: NCT01894971

Last Updated: 2015-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-12-31

Brief Summary

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Single-center prospective randomized trial to evaluate the effect of thermal damage of Ligasure® to destroy cornual portion of fallopian tube tisse.

Right of Left side of fallpian tube is randomized and coagulated one more time than other side before cut off. The pathologist evaluate the amount of fallopian tube tissue left at both cornual portion of cut off specimen.

Detailed Description

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When investigators perform salpingectomy, both side of cornual portion of the uterus are coagulated by Ligasure®. The randomized, the same word selected side of the fallopian tube is coagulated one more time at the cornual portion than unselected other side of fallopian tube. Hypothesis is that the side selected and coagulated twice would have less fallopian tube tisse left at fianl pathology than the side only once coagulated by Ligasure®.

Conditions

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Recruiting Completed

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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twice coagulated side of fallopian tube

twice coagulated side of fallopian tube once coagulated sied of fallopian tube

Group Type EXPERIMENTAL

The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube

Intervention Type DEVICE

Interventions

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The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* female 35-50
* premenopausal
* plan to perform hysterectomy

Exclusion Criteria

* disease in fallopian tube before surgery
* has history of pelvic inflammatory disease
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae-Joong Kim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae Joong Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Unable to connect to PubMed to validate , last attempt on June 25, 2013 at 11:11 AM EDT

Reference Type BACKGROUND

Other Identifiers

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2013-06-25

Identifier Type: -

Identifier Source: org_study_id

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