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

Recruiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894971
• Other study ID #: 2013-06-25
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2013
• Last updated: April 9, 2015
• Start date: November 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Completed
• Recruiting

Intervention

Device:
• The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remnant fallopian tube tissue after coagulation wiht Ligasure®		1 day	No