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

NCT00746018 | Completed Results

• 1 other identifier: 08-092
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer; Ovarian Cancer; Uterine Cancer

Keywords

ovary; uterus; cervix; 08-092

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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 devices.

Device: LigaSure vessel sealing system

Interventions

LigaSure vessel sealing system DEVICE

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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Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Ovarian Neoplasms; Uterine Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Nadeem Abu-Rustum, M.D.
• Organization: Memorial Sloan Kettering Cancer Center

abu-rusn@mskcc.org

212-639-7051

Study Officials

• Nadeem Abu-Rustum, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 11, 2018
• Results First Posted: January 30, 2018

Record last verified: 2017-07

Locations

US (1)