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Thunderbeat Technology vs Standard Bipolar Electro-surgery in Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for Endometrial Cancer (Thunder Endom)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Prof. Giovanni Scambia, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01717794
First Posted: October 30, 2012
Last Update Posted: November 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart
  Purpose

This prospective randomized pilot study is aimed to verify if the operative time of a TLH with pelvic lymphadenectomy for endometrial cancer FIGO stage IB-II could be reduced using Thunderbeat (an ultrasonic energy device that incises and coagulates by using ultrasonic and bipolar technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .

Secondary endpoints of this comparison are incidence of intra- or postoperative complications (Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele), estimated blood loss, postoperative pain (evaluated by VAS), days of hospitalization and costs for the health care system.


Condition Intervention
Endometrial Cancer Procedure: Thunderbeat technology Procedure: Standard bipolar electrosurgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial on Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Endometrial Cancer FIGO Stage IB-II: Thunderbeat Technology Versus Standard Bipolar Electro-surgery.

Resource links provided by NLM:


Further study details as provided by Prof. Giovanni Scambia, Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Operative time for total laparoscopic hysterectomy with pelvic lymphadenectomy [ Time Frame: 24 months ]
    Operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses.


Secondary Outcome Measures:
  • Intra- or post operative complications [ Time Frame: 24 months ]
    Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele


Estimated Enrollment: 36
Study Start Date: October 2012
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard bipolar electrosurgery

Laparoscopic total hysterectomy with pelvic lymphadenectomy are performed with standard bipolar electrosurgery.

A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition telescope.

Two additional 5 mm ports are placed under direct visualization. One more 5-mm trocar is inserted in the right mid abdomen at the level of the umbilicus. The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system.

Procedure: Standard bipolar electrosurgery
Experimental: Thunderbeat technology

Laparoscopic total hysterectomy with pelvic lymphadenectomy are performed with Thunderbeat technology: using Thunderbeat technique, surgeons can avoid changing instruments during surgery since Thunderbeat combines bipolar energy for haemostasis and ultrasound for dissection and cut.

Thunderbeat is used to coagulate the fallopian tubes, to coagulate and divide the round ligaments, to seal ovarian pedicles, to open the anterior and posteriors leaves of the broad ligaments peritoneum, to develop the paravesical and pararectal spaces, to seal uterine arteries and uterine pedicles, to incise the bladder peritoneum, to dissect the bladder, to develop rectovaginal septum, to cut parametria, and to divide the uterosacral ligaments. Thunderbeat is also used to perform the pelvic lymphadenectomy and, if necessary, the para-aortic lymphadenectomy.

Procedure: Thunderbeat technology

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion/Exclusion Criteria:

  • Age ≤ 75 years
  • Patient's informed consent
  • American Society of Anesthesiologists: < class III or IV
  • No actual pregnancies or P.I.D.
  • No previous major abdominal surgical procedures
  • Endometrial cancer FIGO stages IB-II
  • Endometrioid histotype
  • No previous radiotherapy on pelvic fields
  • No uterine size larger than conform 10 weeks gestation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717794


Contacts
Contact: Catholic University of Sacred the Hearth +39 063 015 627 9

Locations
Italy
Catholic University of Sacred the Hearth Recruiting
Rome, Italy, 00100
Principal Investigator: Anna Fagotti, PhD         
Principal Investigator: Francesco Fanfani, MD         
Principal Investigator: Valerio Gallotta, MD         
Principal Investigator: Giuseppe Vizzielli, MD         
Principal Investigator: Elisa Piovano, MD         
Principal Investigator: Raffaella Iodice         
Sponsors and Collaborators
Catholic University of the Sacred Heart
  More Information

Responsible Party: Prof. Giovanni Scambia, Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente - Policlinico Gemelli, Rome, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01717794     History of Changes
Other Study ID Numbers: Thunder Endometrium
First Submitted: October 28, 2012
First Posted: October 30, 2012
Last Update Posted: November 6, 2012
Last Verified: November 2012

Keywords provided by Prof. Giovanni Scambia, Catholic University of the Sacred Heart:
operative time
laparoscopy
total hysterectomy
pelvic lymphadenectomy
endometrial cancer
Thunderbeat

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female