Thermal Spread Into the Interstitial Portion of the Fallopian Tubes Using the Ligasure Device at Time of Hysterectomy

Ovarian Cancer Clinical Trial

Official title:

Evaluation of Thermal Spread Into the Interstitial Portion of the Fallopian Tubes Using the Ligasure Device at Time of Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746018
• Other study ID #: 08-092
• Status: Completed
• Phase: N/A
• First received: September 2, 2008
• Last updated: March 15, 2018
• Start date: August 2008
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Some patients, specifically those with a diagnosed genetic mutation, will have their ovaries and fallopian tubes removed without removal of the uterus in an attempt to prevent ovarian and fallopian tube cancer from developing.

Anatomically the fallopian tubes are attached to the uterus and extend towards the ovaries. The fallopian tube tissue arises within the corner area of the uterus and occupies about 1cm of the uterine muscle wall.

The purpose of this study is to determine if the technique used to remove fallopian tubes only (without removal of the uterus) adequately removes or destroys all the fallopian tube cells that remain in the uterine muscle wall.

Currently, during the operation an instrument is used that burns the fallopian tube and allows it to be cut away from the uterus. The investigators do not know if this procedure successfully destroys all the fallopian tube cells within the uterus. Therefore, we will compare this single step procedure to a two step procedure. The two step procedure is to burn and cut the fallopian tube followed by an additional burning step, called cauterization at the top of the uterus. The investigators will assess if either or both of these procedures destroy the fallopian tube cells that may remain inside the uterine wall. This is important to determine since the goal is to remove the ovaries and all of the fallopian tubes in order to prevent future development of ovarian or fallopian tube cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Women undergoing a non-emergent total hysterectomy with removal of the tubes and ovaries by the gynecologic service for benign or malignant conditions uterine, cervical or early ovarian cancer.

• Patients will undergo either a laparotomy, total laparoscopy or laparoscopically assisted vaginal hysterectomy

• Patients will be 21 years and older.

Exclusion Criteria:

• Patients with abnormal fallopian tubes seen preoperatively by radiologic exam or intraoperatively by visual inspection.

• Patients who are suspected to have fallopian tube cancer prior to their surgery

• Patients who have had prior pelvic radiation therapy

• Patients who are undergoing a Robotically Assisted procedure

• Patients who have had any type of prior tubal surgery

Related Conditions & MeSH terms

• Cervical Cancer
• Ovarian Cancer
• Uterine Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Device:
• LigaSure vessel sealing system
The investigators intend to enroll a total of 60 patients planned to undergo a total hysterectomy and bilateral salpingo-oophorectomy. There will be two techniques compared in this protocol. The first 30 patients will have the right tube removed with one application of the LigaSure. The LigaSure will be placed and the most proximal portion of the right fallopian tube adjacent to the uterine cornua and will be used to coagulate and cut the tube. The next 30 patients will have the tube ligated in the same fashion as group A however an additional step will be added once the fallopian tube has been removed. The LigaSure will be used to cauterize the remaining medial tissue on the cornua region of the uterus.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Determine if the LigaSure Device, Which we Routinely Used for Removal of Tubes and Ovaries, is Effective at Destroying All Tubal Cells Comprising the Fallopian Tube Including Those Cells Within the Cornua of the Uterus.		conclusion of the study

External Links

•   Memorial Sloan-Kettering Cancer Center