<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01717781</url>
  </required_header>
  <id_info>
    <org_study_id>Thunder Cervix</org_study_id>
    <nct_id>NCT01717781</nct_id>
  </id_info>
  <brief_title>Thunderbeat Technology vs Standard Bipolar Electro Surgery in Laparoscopic Radical Hysterectomy and Pelvic Lymphadenectomy for Cervical Cancer</brief_title>
  <acronym>Thunder Cervix</acronym>
  <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&lt;2cm) and Advanced Stage Cervical Cancer (FIGO Stages IB2-IIA&gt;2 Cm-IIB) Submitted to NACT With Complete Clinical Response: Thunderbeat Technology Versus Standard Bipolar Electro Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catholic University of the Sacred Heart</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catholic University of the Sacred Heart</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective randomized pilot study is aimed to verify if the operative time of a LRH&#xD;
      with pelvic lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA&lt;2cm) and&#xD;
      for advanced stage cervical cancer (FIGO stages IB2-IIA&gt;2cm-IIB) submitted to neoadjuvant&#xD;
      chemotherapy with complete clinical response could be reduced using Thunderbeat (an&#xD;
      ultrasonic energy device that incises and coagulates by using ultrasonic and bipolar&#xD;
      technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .&#xD;
&#xD;
      Secondary endpoints of this comparison are incidence of intra- or postoperative&#xD;
      complications, estimated blood loss, postoperative pain, days of hospitalization and costs&#xD;
      for the health care system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radical abdominal hysterectomy (RAH) with pelvic lymphadenectomy is the standard surgical&#xD;
      treatment for early stage cervical carcinoma FIGO stages IA2-IB1-IIA&lt;2cm1. Since the early&#xD;
      90's laparoscopic radical hysterectomy with pelvic lymphadenectomy (LRH) has been suggested&#xD;
      as surgical approach for the treatment of cervical cancer. In the recent years, many&#xD;
      institutions have begun to consider it an attractive technique and to study its feasibility&#xD;
      and safety. Most of these studies have shown that LRH is relatively more time-consuming than&#xD;
      standard laparotomy and ranges from 90 to 420 minutes according to surgeons' experience and&#xD;
      different techniques adopted to achieve hemostasis, resect the parametrium and uterosacrals.&#xD;
      Spirtos et al. demonstrated that staplers could reduce mean operation time from 253 to 205&#xD;
      minutes if compared to argon beam coagulator. Moreover, the pulsed bipolar system was&#xD;
      associated with significant reduction in operative time in comparison with the conventional&#xD;
      bipolar system (mean, 172 minutes vs 229 minutes; P &lt; 0.001). The largest series of LRH&#xD;
      reported from a single institution by Puntambekar et al included 248 patients and described&#xD;
      the &quot;Pune technique&quot; (anterior and posterior peritoneal U cuts, early dissection of the&#xD;
      rectovaginal space, fully mobilization of the uterus, resection of the cardinal and&#xD;
      uterosacral ligaments with Ligasure system (Ligasure Vessel Sealing System; Valleylab, Tyco&#xD;
      Healthcare, Boulder, CO)), obtaining a very short mean operative time (mean, 92 minutes;&#xD;
      range 6-120 minutes).&#xD;
&#xD;
      A recent review on laparoscopic and robot-assisted radical hysterectomy with pelvic&#xD;
      lymphadenectomy including 17 studies reported a mean operating time of 202 minutes [range,&#xD;
      184-221 minutes] in the group of LRH, which matches with our experience of 210 min (range&#xD;
      180-240), using conventional bipolar electrosurgery.&#xD;
&#xD;
      The aim of this pilot RCT is to verify if the operative time of a LRH with pelvic&#xD;
      lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA&lt;2cm) and for&#xD;
      advanced stage cervical cancer (FIGO stages IB2-IIA&gt;2cm-IIB) submitted to neoadjuvant&#xD;
      chemotherapy (NACT) with complete clinical response could be further reduced using&#xD;
      Thunderbeat (an ultrasonic energy device that incises and coagulates by using ultrasonic and&#xD;
      bipolar technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .&#xD;
&#xD;
      Saving operative time would mean shorter anesthesia and faster recovery, further improving&#xD;
      the safety profile of the laparoscopic approach in the treatment of cervical cancer.&#xD;
&#xD;
      Secondary endpoints of this comparison are incidence of intra- or postoperative complications&#xD;
      (Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other&#xD;
      Infection, Lymphocele), estimated blood loss, postoperative pain (evaluated by VAS), days of&#xD;
      hospitalization and costs for the health care system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operative time for laparoscopic radical hysterectomy with pelvic lymphadenectomy</measure>
    <time_frame>24 months</time_frame>
    <description>Operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra- or post operative complications</measure>
    <time_frame>24 months</time_frame>
    <description>Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Thunderbeat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with standard bipolar electrosurgery.&#xD;
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.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thunderbeat technology</intervention_name>
    <arm_group_label>Thunderbeat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard bipolar electrosurgery</intervention_name>
    <arm_group_label>Standard</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion/exclusion criteria&#xD;
&#xD;
          -  Age ≤ 75 years&#xD;
&#xD;
          -  Patient's informed consent&#xD;
&#xD;
          -  American Society of Anesthesiologists: &lt; class III or IV&#xD;
&#xD;
          -  No actual pregnancies or P.I.D.&#xD;
&#xD;
          -  No previous major abdominal surgical procedures For diseases&#xD;
&#xD;
          -  Early stage cervical cancer (FIGO stages IA2-IB1-IIA&lt;2cm) and advanced stage cervical&#xD;
             cancer (FIGO stages IB2-IIA&gt;2cm-IIB) submitted to NACT with complete clinical response&#xD;
&#xD;
          -  No previous radiotherapy on the pelvic field&#xD;
&#xD;
          -  No uterine size larger than conform 10 weeks gestation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Catholic University of Sacred the Hearth</name>
      <address>
        <city>Rome</city>
        <zip>00100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catholic University of Sacred the Hearth</last_name>
      <phone>+39 063 015 627 9</phone>
      <email>ginecol1@rm.unicatt.it</email>
    </contact>
    <investigator>
      <last_name>Anna Fagotti, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Francesco Fanfani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Valerio Gallotta, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giuseppe Vizzielli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elisa Piovano, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Raffaella Iodice</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>November 5, 2012</last_update_submitted>
  <last_update_submitted_qc>November 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catholic University of the Sacred Heart</investigator_affiliation>
    <investigator_full_name>Prof. Giovanni Scambia</investigator_full_name>
    <investigator_title>Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente - Policlinico Gemelli, Rome</investigator_title>
  </responsible_party>
  <keyword>operative time</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>radical hysterectomy</keyword>
  <keyword>pelvic lymphadenectomy</keyword>
  <keyword>cervical cancer</keyword>
  <keyword>thunderbeat</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01717781
org study id: Thunder Cervix
nct id: NCT01717781
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Operative time for laparoscopic radical hysterectomy with pelvic lymphadenectomy
time frame: 24 months
description: Operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses.
measure: Intra- or post operative complications
time frame: 24 months
description: Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele
arm group label: Thunderbeat
arm group type: Experimental
description: 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.
arm group label: Standard
arm group type: Active Comparator
description: 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.
intervention type: Procedure
intervention name: Thunderbeat technology
arm group label: Thunderbeat
intervention type: Procedure
intervention name: Standard bipolar electrosurgery
arm group label: Standard
criteria: 
gender: Female
minimum age: N/A
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Catholic University of the Sacred Heart
investigator full name: Prof. Giovanni Scambia
investigator title: Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente - Policlinico Gemelli, Rome
mesh term: Uterine Cervical Neoplasms