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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00746018 |
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.
Condition | Intervention |
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Cervical Cancer Ovarian Cancer Uterine Cancer |
Device: LigaSure vessel sealing system |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Evaluation of Thermal Spread Into the Interstitial Portion of the Fallopian Tubes Using the Ligasure Device at Time of Hysterectomy |
Estimated Enrollment: | 30 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure device.
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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.
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Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nadeem Abu-Rustum, MD | abu-rusn@mskcc.org | |
Contact: Kay Park, MD | parkk@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering | Recruiting |
New York, New York, United States, 10065 | |
Contact: Nadeem Abu-Rustum, MD abu-rusn@mskcc.org | |
Contact: Kay Park, MD parkk@mskcc.org | |
Principal Investigator: Nadeem Abu-Rustum, MD |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Nadeem Abu-Rustum, MD ) |
Study ID Numbers: | 08-092 |
Study First Received: | September 2, 2008 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00746018 |
Health Authority: | United States: Institutional Review Board |
ovary uterus cervix |
Genital Diseases, Female Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Uterine Diseases |
Endocrine System Diseases Uterine Neoplasms Urogenital Neoplasms Endocrinopathy Ovarian Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |