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

• ClinicalTrials.gov Identifier: NCT00746018
• Recruitment Status: Completed
• First Posted: September 3, 2008
• Results First Posted: January 30, 2018
• Last Update Posted: April 11, 2018
• Sponsor: Memorial Sloan Kettering Cancer Center
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cervical Cancer; Ovarian Cancer; Uterine Cancer	Device: LigaSure vessel sealing system	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Thermal Spread Into the Interstitial Portion of the Fallopian Tubes Using the Ligasure Device at Time of Hysterectomy
• Study Start Date: August 2008
• Actual Primary Completion Date: July 2017
• Actual Study Completion Date: July 2017

Arms and Interventions

Arm

Intervention/treatment

Experimental: 1; 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; 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.

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: conclusion of the study ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New York

Memorial Sloan-Kettering

New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Nadeem Abu-Rustum, MD; Memorial Sloan Kettering Cancer Center

  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:

Study Protocol and Statistical Analysis Plan  [PDF] April 28, 2009

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center 

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT00746018
• Other Study ID Numbers: 08-092
• First Posted: September 3, 2008
• Results First Posted: January 30, 2018
• Last Update Posted: April 11, 2018
• Last Verified: July 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:

ovary; uterus; cervix; 08-092

Additional relevant MeSH terms:

Uterine Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases