Thunderbeat Technology vs Standard Bipolar Electro Surgery in Laparoscopic Radical Hysterectomy and Pelvic Lymphadenectomy for Cervical Cancer (Thunder Cervix)

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:
NCT01717781
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 LRH with pelvic lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA<2cm) and for advanced stage cervical cancer (FIGO stages IB2-IIA>2cm-IIB) submitted to neoadjuvant chemotherapy with complete clinical response 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, estimated blood loss, postoperative pain, days of hospitalization and costs for the health care system.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial on Laparoscopic Radical Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Early Stage Cervical Cancer (FIGO Stages IA2-IB1-IIA<2cm) and Advanced Stage Cervical Cancer (FIGO Stages IB2-IIA>2 Cm-IIB) Submitted to NACT With Complete Clinical Response: 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 laparoscopic radical 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: 26
Study Start Date: October 2012
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thunderbeat

Laparoscopic radical 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 divide the round ligaments, to seal ovarian pedicles, to open the anterior and posteriors leaves of the broad ligaments peritoneum, to incise the bladder peritoneum, to develop the paravesical and pararectal spaces, to seal uterine arteries and uterine pedicles, to dissect the bladder and develop rectovaginal septum, to unroof the ureter, to cut parametria, and to divide the uterosacral ligaments. Monopolar hook is used in the culdotomy. Thunderbeat is also used to perform pelvic lymphadenectomy.

Procedure: Thunderbeat technology
Active Comparator: Standard

Laparoscopic radical 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

Detailed Description:

Radical abdominal hysterectomy (RAH) with pelvic lymphadenectomy is the standard surgical treatment for early stage cervical carcinoma FIGO stages IA2-IB1-IIA<2cm1. Since the early 90's laparoscopic radical hysterectomy with pelvic lymphadenectomy (LRH) has been suggested as surgical approach for the treatment of cervical cancer. In the recent years, many institutions have begun to consider it an attractive technique and to study its feasibility and safety. Most of these studies have shown that LRH is relatively more time-consuming than standard laparotomy and ranges from 90 to 420 minutes according to surgeons' experience and different techniques adopted to achieve hemostasis, resect the parametrium and uterosacrals. Spirtos et al. demonstrated that staplers could reduce mean operation time from 253 to 205 minutes if compared to argon beam coagulator. Moreover, the pulsed bipolar system was associated with significant reduction in operative time in comparison with the conventional bipolar system (mean, 172 minutes vs 229 minutes; P < 0.001). The largest series of LRH reported from a single institution by Puntambekar et al included 248 patients and described the "Pune technique" (anterior and posterior peritoneal U cuts, early dissection of the rectovaginal space, fully mobilization of the uterus, resection of the cardinal and uterosacral ligaments with Ligasure system (Ligasure Vessel Sealing System; Valleylab, Tyco Healthcare, Boulder, CO)), obtaining a very short mean operative time (mean, 92 minutes; range 6-120 minutes).

A recent review on laparoscopic and robot-assisted radical hysterectomy with pelvic lymphadenectomy including 17 studies reported a mean operating time of 202 minutes [range, 184-221 minutes] in the group of LRH, which matches with our experience of 210 min (range 180-240), using conventional bipolar electrosurgery.

The aim of this pilot RCT is to verify if the operative time of a LRH with pelvic lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA<2cm) and for advanced stage cervical cancer (FIGO stages IB2-IIA>2cm-IIB) submitted to neoadjuvant chemotherapy (NACT) with complete clinical response could be further 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 .

Saving operative time would mean shorter anesthesia and faster recovery, further improving the safety profile of the laparoscopic approach in the treatment of cervical cancer.

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.

  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 For diseases
  • Early stage cervical cancer (FIGO stages IA2-IB1-IIA<2cm) and advanced stage cervical cancer (FIGO stages IB2-IIA>2cm-IIB) submitted to NACT with complete clinical response
  • No previous radiotherapy on the pelvic field
  • 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: NCT01717781

Locations
Italy
Catholic University of Sacred the Hearth Recruiting
Rome, Italy, 00100
Contact: Catholic University of Sacred the Hearth    +39 063 015 627 9    ginecol1@rm.unicatt.it   
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: NCT01717781     History of Changes
Other Study ID Numbers: Thunder Cervix
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
radical hysterectomy
pelvic lymphadenectomy
cervical cancer
thunderbeat

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

ClinicalTrials.gov processed this record on September 22, 2014