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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Catholic University of the Sacred Heart
Sponsor:
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01717794
First received: October 28, 2012
Last updated: November 5, 2012
Last verified: November 2012
  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: 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 Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Operative time for total laparoscopic hysterectomy with pelvic lymphadenectomy [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   up to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 28, 2012
Last Updated: November 5, 2012
Health Authority: Italy: Ethics Committee, Catholic University of the Sacred Hearth

Keywords provided by 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

ClinicalTrials.gov processed this record on October 19, 2014