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


N/A
21 Years
N/A
Open (Enrolling)
Female
Cervical Cancer, Ovarian Cancer, Uterine Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

conclusion of the study

Safety Issue:

No

Principal Investigator

Nadeem Abu-Rustum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08-092

NCT ID:

NCT00746018

Start Date:

August 2008

Completion Date:

August 2013

Related Keywords:

  • Cervical Cancer
  • Ovarian Cancer
  • Uterine Cancer
  • ovary
  • uterus
  • cervix
  • 08-092
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Uterine Neoplasms

Name

Location

Memorial Sloan-KetteringNew York, New York