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



Status:Completed
Conditions:Ovarian Cancer, Cervical Cancer, Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:21 - Any
Updated:4/17/2018
Start Date:August 2008
End Date:July 2017

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

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.


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
We found this trial at
1
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New York, New York 10065
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