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

April 9, 2015 updated by: Tae-Joong Kim, Samsung Medical Center

The Effect of Thermal Damage of Ligasure® to Destroy Cornual Portion of Fallopian Tube Tissue

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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®.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • disease in fallopian tube before surgery
  • has history of pelvic inflammatory disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: twice coagulated side of fallopian tube
twice coagulated side of fallopian tube once coagulated sied of fallopian tube
Device: The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Remnant fallopian tube tissue after coagulation wiht Ligasure®
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Tae Joong Kim, MD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

July 3, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2013-06-25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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