Thunderbeat Technology vs Standard Bipolar Electro-surgery in Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for Endometrial Cancer (Thunder Endom)
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.
Procedure: Thunderbeat technology
Procedure: Standard bipolar electrosurgery
|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.|
- 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.
- 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
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
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|
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|Contact: Catholic University of Sacred the Hearth||+39 063 015 627 9|
|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|