<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/NCT01717794</url>
  </required_header>
  <id_info>
    <org_study_id>Thunder Endometrium</org_study_id>
    <nct_id>NCT01717794</nct_id>
  </id_info>
  <brief_title>Thunderbeat Technology vs Standard Bipolar Electro-surgery in Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for Endometrial Cancer</brief_title>
  <acronym>Thunder Endom</acronym>
  <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.</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 TLH&#xD;
      with pelvic lymphadenectomy for endometrial cancer FIGO stage IB-II could be 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;
      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>
  </brief_summary>
  <detailed_description>
    <textblock>
      The standard treatment for early-stage endometrial cancer is surgery. Surgical procedures&#xD;
      include washing for cytology, total extrafascial hysterectomy and bilateral&#xD;
      salpingo-oophorectomy. Although the therapeutic value of routine pelvic and para-aortic&#xD;
      lymphadenectomy is debated, staging information is a critical determinant of adjuvant therapy&#xD;
      for most gynecologic oncologists.&#xD;
&#xD;
      Type-1 endometrial cancer spread is limited to the pelvic nodes in most cases. If there are&#xD;
      positive lymph nodes, those around the obturator nerve and around the external and common&#xD;
      iliac vessels are more likely to be involved than those in the presacral area. Isolated&#xD;
      involvement of the para-aortic nodes is rare. Complete excision of the nodes located around&#xD;
      the iliac vessels and above the obturator nerve allows identiﬁcation of 90% of node-positive&#xD;
      patients.&#xD;
&#xD;
      The decision on whether to undertake lymphadenectomy should not be based on palpation of the&#xD;
      nodal area, because less than 10% of patients with nodal metastases have grossly enlarged&#xD;
      nodes.&#xD;
&#xD;
      Patients with endometrioid cancer, grade 1-2 with deep myometrial invasion and any grade 3&#xD;
      endometrioid endometrial cancer have at least a 5% risk of having positive pelvic lymph&#xD;
      nodes. In our current treatment protocol, these patients undergo complete pelvic&#xD;
      lymphadenectomy. Laparotomy may be indicated in endometrial cancer patients presenting with&#xD;
      grossly positive pelvic nodes, grossly positive adnexal metastasis, or serosal inﬁltration.&#xD;
&#xD;
      Although the complication rate of a simple hysterectomy with bilateral salpingo-oophorectomy&#xD;
      is not very high, over 70% new cases of endometrial cancer are diagnosed in post-menopausal&#xD;
      women, commonly associated with medical co-morbidities, such as diabetes, hypertension and&#xD;
      obesity. Abdominal surgery therefore exposes them to an increased risk of complications.&#xD;
      Vaginal hysterectomy has been suggested as an attractive alternative to abdominal surgery for&#xD;
      these patients, but this approach does not allow exploration of the abdominal cavity,&#xD;
      peritoneal washing, and lymph-node dissection. Laparoscopic-assisted vaginal hysterectomy or&#xD;
      total laparoscopic hysterectomy overcome the previous limitations.&#xD;
&#xD;
      In 1993, Childers et al first proposed laparoscopy as an option for early-stage endometrial&#xD;
      cancer. Despite its recognized benefits, many surgeons found this approach difficult for&#xD;
      routine use such that relatively few centers offered laparoscopic hysterectomy and&#xD;
      lymphadenectomy for a majority of their patients.&#xD;
&#xD;
      From those first reports there have been 12 major reports on the use of laparoscopy, often&#xD;
      comparing to series of similar patients staged by laparotomy. Clear advantages, such as the&#xD;
      reduction of peri-operative complications, the shorter hospital stay and the earlier&#xD;
      recovery, have been confirmed in each series. Failure to complete the staging procedure by&#xD;
      laparoscopy ranges between 5 and 35% of the patients, most frequently due to obesity of the&#xD;
      patients. In reality in 2005 some researchers have suggested that laparoscopic surgery is&#xD;
      safe in obese or elderly patients with endometrial cancer too.&#xD;
&#xD;
      Moreover, this approach does not seem to modify the incidence of recurrence and overall&#xD;
      patient survival. The big randomized trials planned to study differences in morbidity and&#xD;
      survival between laparoscopy or laparotomy in endometrial cancer are the GOG LAP-2 study, the&#xD;
      Dutch study from Bijen and Mourits, and the Australian study LACE. Unfortunately none of&#xD;
      these three randomised trials have yet reported survival data, but only on health-related&#xD;
      issues and complications. In the GOG study 33, patients with clinical stage I to IIA uterine&#xD;
      cancer were randomly assigned to laparoscopy (n = 1,696) or open laparotomy (n = 920),&#xD;
      including hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic&#xD;
      lymphadenectomy. Laparoscopy resulted in fewer postoperative moderate or severe adverse&#xD;
      events, a shorter hospital stay, and a longer operative time than did laparotomy. The median&#xD;
      operative time for the open laparotomy arm was 130 minutes (range 102-167 minutes), and for&#xD;
      the laparoscopy arm, it was 204 minutes (rang 160-252 minutes; P &lt; .001).&#xD;
&#xD;
      In the Dutch 34-35 study the major and minor complication rates were the same in the group of&#xD;
      patients treated with laparoscopy compared with laparotomy. However, TLH was associated with&#xD;
      less blood loss, less use of pain medication, a shorter hospital stay, and a longer operative&#xD;
      time than with TAH. The median duration of surgery was 115 minutes in the TLH group, (range&#xD;
      35-267) and 71 minutes (range 31-239) in the TAH group. The difference with the GOG study is&#xD;
      probably due to the fact that the patients in the Netherlands only underwent a hysterectomy&#xD;
      and bilateral salpingo-oophorectomy and not a complete surgical staging including pelvic and&#xD;
      para-aortic lymphadenectomy.&#xD;
&#xD;
      In the Australian LACE study 36 patients with stage I endometrioid adenocarcinoma were&#xD;
      randomly assigned to TLH (n=190) or TAH (n=142). Surgeons were required to perform pelvic&#xD;
      node (with or without) para-aortic lymph-node dissection as part of the treatment in both&#xD;
      groups. Operating time was significantly longer in the TLH group (138 minutes [SD 43]) than&#xD;
      in the TAH group (109 minutes [34]; p=0•001).&#xD;
&#xD;
      Health-related outcome was reported in all three trials. Better physical functioning, body&#xD;
      image, reduced pain, and an earlier resumption of work over the 6-week post-laparoscopy&#xD;
      period was reported in the GOG and the Dutch study than in the laparotomy patients, but these&#xD;
      differences disappeared 6 months after surgery. In the Australian study, quality of life was&#xD;
      still improved 6 months after surgery.&#xD;
&#xD;
      In conclusion, laparoscopic treatment of endometrial cancer clinically confined to the uterus&#xD;
      is associated with less pain, shorter hospital stay, faster recovery, and better quality of&#xD;
      life at least 3 months post surgery, but with a longer operative time than with laparotomy.&#xD;
&#xD;
      Another recent single institution Italian trial randomized patients with clinical stage I&#xD;
      endometrial cancer to receive TLH (n=81) or TAH (n=78) with bilateral salpingo-oophorectomy&#xD;
      and bilateral pelvic lymphadenectomy. 37 Para-aortic lymphadenectomy was performed in&#xD;
      selected cases. The mean operative time was 123 minutes ± 29 (95% CI 111-198) in the LPT&#xD;
      group and 136 minutes ± 31 (95% CI 118- 181) in the LPS group (P&lt;0.01). These operative times&#xD;
      match closely with our experience by both laparotomy and laparoscopy, using conventional&#xD;
      bipolar electrosurgery.&#xD;
&#xD;
      Shortening the operative time of laparoscopy could further increase the benefits of the&#xD;
      laparoscopic approach, especially in obese patients. Overweight (defined as body-mass index&#xD;
      [BMI] of at least 25 kg/m2) is an important risk factor present in almost 50% of women with&#xD;
      endometrial cancer.&#xD;
&#xD;
      Since these patients are characterised by several systemic physiopathological alterations,&#xD;
      the perioperative management may present some problems, mainly related to their respiratory&#xD;
      system (obstructive sleep apnea, airway intubation and atelectasis). Obstructive sleep&#xD;
      apnea-hypopnea syndrome (OSA) occurs in up to 70% of morbidly obese patients undergoing&#xD;
      surgery 39 being OSA a known risk factor for adverse perioperative outcomes.&#xD;
&#xD;
      Shortening the operative time could reduce these perioperative complications and the&#xD;
      postoperative pain. This could translate in fewer days of hospitalization and than lower&#xD;
      incidence of hospital infections and lower 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 total laparoscopic 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">36</enrollment>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>Standard bipolar electrosurgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic total 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>
  <arm_group>
    <arm_group_label>Thunderbeat technology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thunderbeat technology</intervention_name>
    <arm_group_label>Thunderbeat technology</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard bipolar electrosurgery</intervention_name>
    <arm_group_label>Standard bipolar electrosurgery</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&#xD;
&#xD;
          -  Endometrial cancer FIGO stages IB-II&#xD;
&#xD;
          -  Endometrioid histotype&#xD;
&#xD;
          -  No previous radiotherapy on pelvic fields&#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>
  <overall_contact>
    <last_name>Catholic University of Sacred the Hearth</last_name>
    <phone>+39 063 015 627 9</phone>
  </overall_contact>
  <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>
    <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 29, 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>total hysterectomy</keyword>
  <keyword>pelvic lymphadenectomy</keyword>
  <keyword>endometrial cancer</keyword>
  <keyword>Thunderbeat</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial 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/NCT01717794
org study id: Thunder Endometrium
nct id: NCT01717794
lead sponsor: 
has dmc: Yes
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.
The standard treatment for early-stage endometrial cancer is surgery. Surgical procedures
      include washing for cytology, total extrafascial hysterectomy and bilateral
      salpingo-oophorectomy. Although the therapeutic value of routine pelvic and para-aortic
      lymphadenectomy is debated, staging information is a critical determinant of adjuvant therapy
      for most gynecologic oncologists.

      Type-1 endometrial cancer spread is limited to the pelvic nodes in most cases. If there are
      positive lymph nodes, those around the obturator nerve and around the external and common
      iliac vessels are more likely to be involved than those in the presacral area. Isolated
      involvement of the para-aortic nodes is rare. Complete excision of the nodes located around
      the iliac vessels and above the obturator nerve allows identiﬁcation of 90% of node-positive
      patients.

      The decision on whether to undertake lymphadenectomy should not be based on palpation of the
      nodal area, because less than 10% of patients with nodal metastases have grossly enlarged
      nodes.

      Patients with endometrioid cancer, grade 1-2 with deep myometrial invasion and any grade 3
      endometrioid endometrial cancer have at least a 5% risk of having positive pelvic lymph
      nodes. In our current treatment protocol, these patients undergo complete pelvic
      lymphadenectomy. Laparotomy may be indicated in endometrial cancer patients presenting with
      grossly positive pelvic nodes, grossly positive adnexal metastasis, or serosal inﬁltration.

      Although the complication rate of a simple hysterectomy with bilateral salpingo-oophorectomy
      is not very high, over 70% new cases of endometrial cancer are diagnosed in post-menopausal
      women, commonly associated with medical co-morbidities, such as diabetes, hypertension and
      obesity. Abdominal surgery therefore exposes them to an increased risk of complications.
      Vaginal hysterectomy has been suggested as an attractive alternative to abdominal surgery for
      these patients, but this approach does not allow exploration of the abdominal cavity,
      peritoneal washing, and lymph-node dissection. Laparoscopic-assisted vaginal hysterectomy or
      total laparoscopic hysterectomy overcome the previous limitations.

      In 1993, Childers et al first proposed laparoscopy as an option for early-stage endometrial
      cancer. Despite its recognized benefits, many surgeons found this approach difficult for
      routine use such that relatively few centers offered laparoscopic hysterectomy and
      lymphadenectomy for a majority of their patients.

      From those first reports there have been 12 major reports on the use of laparoscopy, often
      comparing to series of similar patients staged by laparotomy. Clear advantages, such as the
      reduction of peri-operative complications, the shorter hospital stay and the earlier
      recovery, have been confirmed in each series. Failure to complete the staging procedure by
      laparoscopy ranges between 5 and 35% of the patients, most frequently due to obesity of the
      patients. In reality in 2005 some researchers have suggested that laparoscopic surgery is
      safe in obese or elderly patients with endometrial cancer too.

      Moreover, this approach does not seem to modify the incidence of recurrence and overall
      patient survival. The big randomized trials planned to study differences in morbidity and
      survival between laparoscopy or laparotomy in endometrial cancer are the GOG LAP-2 study, the
      Dutch study from Bijen and Mourits, and the Australian study LACE. Unfortunately none of
      these three randomised trials have yet reported survival data, but only on health-related
      issues and complications. In the GOG study 33, patients with clinical stage I to IIA uterine
      cancer were randomly assigned to laparoscopy (n = 1,696) or open laparotomy (n = 920),
      including hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic
      lymphadenectomy. Laparoscopy resulted in fewer postoperative moderate or severe adverse
      events, a shorter hospital stay, and a longer operative time than did laparotomy. The median
      operative time for the open laparotomy arm was 130 minutes (range 102-167 minutes), and for
      the laparoscopy arm, it was 204 minutes (rang 160-252 minutes; P < .001).

      In the Dutch 34-35 study the major and minor complication rates were the same in the group of
      patients treated with laparoscopy compared with laparotomy. However, TLH was associated with
      less blood loss, less use of pain medication, a shorter hospital stay, and a longer operative
      time than with TAH. The median duration of surgery was 115 minutes in the TLH group, (range
      35-267) and 71 minutes (range 31-239) in the TAH group. The difference with the GOG study is
      probably due to the fact that the patients in the Netherlands only underwent a hysterectomy
      and bilateral salpingo-oophorectomy and not a complete surgical staging including pelvic and
      para-aortic lymphadenectomy.

      In the Australian LACE study 36 patients with stage I endometrioid adenocarcinoma were
      randomly assigned to TLH (n=190) or TAH (n=142). Surgeons were required to perform pelvic
      node (with or without) para-aortic lymph-node dissection as part of the treatment in both
      groups. Operating time was significantly longer in the TLH group (138 minutes [SD 43]) than
      in the TAH group (109 minutes [34]; p=0•001).

      Health-related outcome was reported in all three trials. Better physical functioning, body
      image, reduced pain, and an earlier resumption of work over the 6-week post-laparoscopy
      period was reported in the GOG and the Dutch study than in the laparotomy patients, but these
      differences disappeared 6 months after surgery. In the Australian study, quality of life was
      still improved 6 months after surgery.

      In conclusion, laparoscopic treatment of endometrial cancer clinically confined to the uterus
      is associated with less pain, shorter hospital stay, faster recovery, and better quality of
      life at least 3 months post surgery, but with a longer operative time than with laparotomy.

      Another recent single institution Italian trial randomized patients with clinical stage I
      endometrial cancer to receive TLH (n=81) or TAH (n=78) with bilateral salpingo-oophorectomy
      and bilateral pelvic lymphadenectomy. 37 Para-aortic lymphadenectomy was performed in
      selected cases. The mean operative time was 123 minutes ± 29 (95% CI 111-198) in the LPT
      group and 136 minutes ± 31 (95% CI 118- 181) in the LPS group (P<0.01). These operative times
      match closely with our experience by both laparotomy and laparoscopy, using conventional
      bipolar electrosurgery.

      Shortening the operative time of laparoscopy could further increase the benefits of the
      laparoscopic approach, especially in obese patients. Overweight (defined as body-mass index
      [BMI] of at least 25 kg/m2) is an important risk factor present in almost 50% of women with
      endometrial cancer.

      Since these patients are characterised by several systemic physiopathological alterations,
      the perioperative management may present some problems, mainly related to their respiratory
      system (obstructive sleep apnea, airway intubation and atelectasis). Obstructive sleep
      apnea-hypopnea syndrome (OSA) occurs in up to 70% of morbidly obese patients undergoing
      surgery 39 being OSA a known risk factor for adverse perioperative outcomes.

      Shortening the operative time could reduce these perioperative complications and the
      postoperative pain. This could translate in fewer days of hospitalization and than lower
      incidence of hospital infections and lower costs for the health care system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Operative time for total laparoscopic 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: Standard bipolar electrosurgery
arm group type: Active Comparator
description: 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.
arm group label: Thunderbeat technology
arm group type: Experimental
description: 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.
intervention type: Procedure
intervention name: Thunderbeat technology
arm group label: Thunderbeat technology
intervention type: Procedure
intervention name: Standard bipolar electrosurgery
arm group label: Standard bipolar electrosurgery
criteria: 
gender: Female
minimum age: N/A
maximum age: 75 Years
healthy volunteers: No
last name: Catholic University of Sacred the Hearth
phone: +39 063 015 627 9
facility: 
status: Recruiting
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: Endometrial Neoplasms