xml: <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/NCT05974995</url>
    </required_header>
    <id_info>
      <org_study_id>5798</org_study_id>
      <nct_id>NCT05974995</nct_id>
    </id_info>
    <brief_title>Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer</brief_title>
    <acronym>RObese</acronym>
    <official_title>Robotic-assisted Versus Conventional Laparoscopic Surgery in the Management of Obese Patients With Early Endometrial Cancer in the Sentinel Lymph Node Era: a Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Data across literature suggest that robotic surgery may offer benefit specifically in patient&#xD;
        with morbid obesity with endometrial cancer, but to date no randomized trials have been&#xD;
        conducted to confirm these observations.&#xD;
  &#xD;
        This randomized controlled multicentric trial aims to evaluate the most appropriate minimally&#xD;
        invasive surgical approach in morbidly obese (BMI &gt;= 30) patients with endometrial carcinoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background:&#xD;
  &#xD;
        Endometrial cancer is the fourth cancer in women, the most common gynecologic cancer in&#xD;
        high-income countries and the second most common gynecologic cancer worldwide.&#xD;
  &#xD;
        The high incidence of endometrial cancer is associated with several risk factors, but the&#xD;
        growing prevalence of obesity has been identified as one of the majors. Many patients with&#xD;
        endometrial cancer are obese and have clinically relevant coexisting conditions that&#xD;
        negatively affects anesthesiological parameters and surgical performance when patients&#xD;
        undergo surgery, thus potentially increasing the risk of peri-operative complications.&#xD;
  &#xD;
        For patients presenting at early-stage disease the standard procedure is total hysterectomy&#xD;
        with bilateral salpingo-oophorectomy and lymph nodal staging. Prospective and retrospective&#xD;
        studies demonstrate that compared to systemic lymphadenectomy, sentinel lymph node mapping&#xD;
        have high accuracy in detecting nodal metastases, and together with ultrastaging may increase&#xD;
        the detection of lymph node metastasis with low false-negative rates in patients with&#xD;
        apparent uterine-confined disease. Also, recent evidence proved sentinel lymph node biopsy to&#xD;
        be a feasible and safe alternative to lymphadenectomy in high-risk endometrial cancer.&#xD;
  &#xD;
        Many randomized prospective studies proved laparoscopic surgical staging to be feasible in&#xD;
        terms of short-term outcomes, equivalent in disease-free survival and no different in overall&#xD;
        survival, thus the current surgical approach is minimally invasive. Also, innovative surgical&#xD;
        approaches such as robotic surgery have been exploited showing equivalent oncologic outcomes&#xD;
        when compared to traditional laparoscopic surgery.&#xD;
  &#xD;
        In 2015, Uccella et al. proved that laparoscopy is superior to open surgery even in case of&#xD;
        morbid obesity. Particularly, minimally invasive surgery has been shown to have faster&#xD;
        recovery and a higher likelihood of retroperitoneal staging in morbid obese patients, even if&#xD;
        the number of women who received lymphadenectomy was found to be stable up to class II of&#xD;
        obesity and then dramatically decreased to 30% for BMI&gt;40. Similarly, the number of lymph&#xD;
        nodes removed (when lymphadenectomy was accomplished), decreased significantly in class III&#xD;
        obesity. However, the removal of lymph nodes can be less relevant in the era of sentinel&#xD;
        lymph node. Once, the completing of lymphadenectomy could imply the need of conversion. In&#xD;
        fact, the Gynecologic Oncology Group LAP2 trial showed that the odds of conversion to&#xD;
        laparotomy during laparoscopic staging increased significantly with each unit increase in&#xD;
        BMI, but the reason for conversion was mainly when an adequate surgical staging cannot be&#xD;
        completed.&#xD;
  &#xD;
        In many retrospective studies robotic surgery has been shown to have advantages when compared&#xD;
        to laparoscopy in obese patients. Cusimano et al published a systematic review and&#xD;
        meta-analysis aiming to evaluate rates of conversion to laparotomy with laparoscopy or&#xD;
        robotic surgery specifically in patients with endometrial cancer and BMI &gt;30Kg/m2: they&#xD;
        included 51 observational studies with a total of 10,800 patients overall and found out that&#xD;
        although the conversion rate for patients with BMI&gt;30 Kg/m2 is comparable between laparoscopy&#xD;
        and robotic surgery, the proportion of patients with BMI &gt;40 kg/m2 who experienced conversion&#xD;
        seems to be higher in laparoscopy compared with robotic. Different reasons were described for&#xD;
        conversion: organ/vessel injury, uterine size, advanced/ metastatic disease, inadequate&#xD;
        exposure because of adhesions or visceral adiposity, anesthesiologic indications.&#xD;
  &#xD;
        In conclusion, data across literature suggest that robotic surgery may offer benefit&#xD;
        specifically in patient with morbid obesity, but to date no randomized trials have been&#xD;
        conducted to confirm these observations. Furthermore, conclusive data are needed to evaluate&#xD;
        length of hospitalization, intraoperative and postoperative complications, adherence to the&#xD;
        MSKCC nodal staging algorithm, and oncological outcomes in this group of patients. Robust&#xD;
        data in morbidly obese endometrial cancer patients to choose the most appropriate surgical&#xD;
        technique are missing, particularly in the era of sentinel lymph node. Moreover, conversion&#xD;
        to laparotomy in the previous study occurred to achieve a complete surgical staging with&#xD;
        lymphadenectomy. Thus, investigators expect to have a lower conversion rate in this study.&#xD;
  &#xD;
        Rationale:&#xD;
  &#xD;
        The rationale of the study is to find the most appropriate minimally invasive surgical&#xD;
        approach in morbidly obese patients with endometrial carcinoma&#xD;
  &#xD;
        Objectives:&#xD;
  &#xD;
        Primary objective: To evaluate conversion rate to laparotomy with robotic surgery vs&#xD;
        laparoscopic surgery (laparoscopic surgery referent group)&#xD;
  &#xD;
        Secondary objectives:&#xD;
  &#xD;
          -  To evaluate difference in overall duration of surgery&#xD;
  &#xD;
          -  To evaluate difference in perioperative complications&#xD;
  &#xD;
          -  To evaluate the adherence to sentinel lymph node MSKCC algorithm&#xD;
  &#xD;
          -  To compare ergonomics of the two different surgical approach&#xD;
  &#xD;
          -  To compare quality of life (QoL) at baseline, 1 and 4 weeks (early), and 3 and 6 months&#xD;
             (late) after surgery, using the Functional Assessment of Cancer Therapy-General (FACT-G)&#xD;
             questionnaire&#xD;
  &#xD;
          -  To assess adherence to ESGO surgical Quality Index (QI, rate of uterine rupture)&#xD;
  &#xD;
          -  To evaluate difference in overall survival and disease-free survival&#xD;
  &#xD;
        Primary end point: the number of surgical procedures that need a conversion over the total&#xD;
        number of surgical procedures in the two arms.&#xD;
  &#xD;
        Secondary end points:&#xD;
  &#xD;
          -  Duration in minutes of surgery&#xD;
  &#xD;
          -  Number of patients with at least one perioperative complications measured by Clavien&#xD;
             Dindo&#xD;
  &#xD;
          -  To evaluate the ergonomics through the Rapid Upper Limb Assessment (RULA) assessment&#xD;
             tool&#xD;
  &#xD;
          -  Disease-Free Survival (DFS) defined as the time between randomization and the first&#xD;
             detection of relapse or death, whichever event occurs first; for patients without events&#xD;
             DFS will be censored at the date of last follow-up&#xD;
  &#xD;
          -  Overall Survival (OS) defined as the time between randomization and death for any cause;&#xD;
             for alive patients OS will be censored at the date of last follow-up&#xD;
  &#xD;
        Study Design: Randomized Controlled Multicentric Superiority trial&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2029</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2026</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>Conversion rate</measure>
      <time_frame>At the end of the enrollment phase</time_frame>
      <description>Number of procedures converted to laparotomy from MIS</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Difference in overall duration of surgery</measure>
      <time_frame>At the end of the enrollment phase</time_frame>
      <description>Difference in duration of procedures measured in minutes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in perioperative complications</measure>
      <time_frame>36 and 72 months</time_frame>
      <description>Number of patients with at least one perioperative complications measured by Clavien Dindo</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to sentinel lymph node MSKCC algorithm</measure>
      <time_frame>At the end of the enrollment phase</time_frame>
      <description>Number of case with completed lymph nodal staging according to MSKCC algorithm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ergonomics of the two different surgical approach</measure>
      <time_frame>At the end of the enrollment phase</time_frame>
      <description>Investigators will evaluate the ergonomics of the two MIS system through the Rapid Upper Limb Assessment (RULA) assessment tool. Rula is aimed to make a rapid assessment on neck and upper limb loading in tasks. The risk of work-related disorders is calculated into a score of 1(low) to 7 (high)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life (QoL) at baseline, 1 and 4 weeks (early), and 3 and 6 months (late) after surgery</measure>
      <time_frame>1 and 4 weeks (early), and 3 and 6 months (late) after surgery</time_frame>
      <description>Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire will be used. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure physical, social, emotional, and functional well-being in cancer patients. The score range 0-108; the higher the score, the better the QOL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to ESGO surgical Quality Index</measure>
      <time_frame>36 and 72 months</time_frame>
      <description>Investigators will assess adherence to ESGO surgical Quality Index (QI, rate of uterine rupture)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in overall survival and disease-free survival</measure>
      <time_frame>36 and 72 months</time_frame>
      <description>Investigators will evaluate difference in Overall Survival, defined as the time between randomization and death for any cause, for alive patients OS will be censored at the date of last follow-up; investigators will evaluate difference in disease-free survival, defined as the time between randomization and the first detection of relapse or death, whichever event occurs first; for patients without events DFS will be censored at the date of last follow-up</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">566</enrollment>
    <condition>Endometrial Cancer</condition>
    <condition>Endometrial Neoplasms</condition>
    <condition>Obesity, Morbid</condition>
    <condition>Gynecologic Cancer</condition>
    <condition>Gynecologic Disease</condition>
    <arm_group>
      <arm_group_label>Robotic surgery</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Laparoscopic surgery</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Robot-assisted surgery</intervention_name>
      <description>Total hysterectomy with bilateral salpingo-oophorectomy and lymphnodes staging using DaVinci Xi</description>
      <arm_group_label>Robotic surgery</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Laparoscopic surgery</intervention_name>
      <description>Total hysterectomy with bilateral salpingo-oophorectomy and lymph nodes staging using standard laparoscopic approach</description>
      <arm_group_label>Laparoscopic surgery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  BMI &gt;=30&#xD;
  &#xD;
            -  Age &gt; 18&#xD;
  &#xD;
            -  Histologically confirmed endometrioid endometrial cancer&#xD;
  &#xD;
            -  Clinical early stage (stage I)&#xD;
  &#xD;
            -  No contraindication for minimally invasive surgery&#xD;
  &#xD;
            -  ASA&lt;4&#xD;
  &#xD;
            -  Written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  High probability of laparotomy related to uterine volume (US estimated weight &gt;250 g)&#xD;
  &#xD;
            -  Concomitant pelvic disease, or anatomical characteristics of the patient&#xD;
  &#xD;
            -  (Use of uterine manipulator)&#xD;
  &#xD;
            -  Age &gt;75 years&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Francesco Fanfani, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Policlinico Gemelli IRCCS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Francesco Fanfani, MD</last_name>
      <phone>0630153421</phone>
      <email>francesco.fanfani@policlinicogemelli.it</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
      <investigator_full_name>Fanfani Francesco</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endometrial Neoplasms</mesh_term>
      <mesh_term>Genital Diseases, Female</mesh_term>
      <mesh_term>Obesity, Morbid</mesh_term>
    </condition_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>April 7, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT05974995/Prot_SAP_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974995
  org study id: 5798
  nct id: NCT05974995
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Data across literature suggest that robotic surgery may offer benefit specifically in patient
        with morbid obesity with endometrial cancer, but to date no randomized trials have been
        conducted to confirm these observations.
  
        This randomized controlled multicentric trial aims to evaluate the most appropriate minimally
        invasive surgical approach in morbidly obese (BMI >= 30) patients with endometrial carcinoma.
  Background:
  
        Endometrial cancer is the fourth cancer in women, the most common gynecologic cancer in
        high-income countries and the second most common gynecologic cancer worldwide.
  
        The high incidence of endometrial cancer is associated with several risk factors, but the
        growing prevalence of obesity has been identified as one of the majors. Many patients with
        endometrial cancer are obese and have clinically relevant coexisting conditions that
        negatively affects anesthesiological parameters and surgical performance when patients
        undergo surgery, thus potentially increasing the risk of peri-operative complications.
  
        For patients presenting at early-stage disease the standard procedure is total hysterectomy
        with bilateral salpingo-oophorectomy and lymph nodal staging. Prospective and retrospective
        studies demonstrate that compared to systemic lymphadenectomy, sentinel lymph node mapping
        have high accuracy in detecting nodal metastases, and together with ultrastaging may increase
        the detection of lymph node metastasis with low false-negative rates in patients with
        apparent uterine-confined disease. Also, recent evidence proved sentinel lymph node biopsy to
        be a feasible and safe alternative to lymphadenectomy in high-risk endometrial cancer.
  
        Many randomized prospective studies proved laparoscopic surgical staging to be feasible in
        terms of short-term outcomes, equivalent in disease-free survival and no different in overall
        survival, thus the current surgical approach is minimally invasive. Also, innovative surgical
        approaches such as robotic surgery have been exploited showing equivalent oncologic outcomes
        when compared to traditional laparoscopic surgery.
  
        In 2015, Uccella et al. proved that laparoscopy is superior to open surgery even in case of
        morbid obesity. Particularly, minimally invasive surgery has been shown to have faster
        recovery and a higher likelihood of retroperitoneal staging in morbid obese patients, even if
        the number of women who received lymphadenectomy was found to be stable up to class II of
        obesity and then dramatically decreased to 30% for BMI>40. Similarly, the number of lymph
        nodes removed (when lymphadenectomy was accomplished), decreased significantly in class III
        obesity. However, the removal of lymph nodes can be less relevant in the era of sentinel
        lymph node. Once, the completing of lymphadenectomy could imply the need of conversion. In
        fact, the Gynecologic Oncology Group LAP2 trial showed that the odds of conversion to
        laparotomy during laparoscopic staging increased significantly with each unit increase in
        BMI, but the reason for conversion was mainly when an adequate surgical staging cannot be
        completed.
  
        In many retrospective studies robotic surgery has been shown to have advantages when compared
        to laparoscopy in obese patients. Cusimano et al published a systematic review and
        meta-analysis aiming to evaluate rates of conversion to laparotomy with laparoscopy or
        robotic surgery specifically in patients with endometrial cancer and BMI >30Kg/m2: they
        included 51 observational studies with a total of 10,800 patients overall and found out that
        although the conversion rate for patients with BMI>30 Kg/m2 is comparable between laparoscopy
        and robotic surgery, the proportion of patients with BMI >40 kg/m2 who experienced conversion
        seems to be higher in laparoscopy compared with robotic. Different reasons were described for
        conversion: organ/vessel injury, uterine size, advanced/ metastatic disease, inadequate
        exposure because of adhesions or visceral adiposity, anesthesiologic indications.
  
        In conclusion, data across literature suggest that robotic surgery may offer benefit
        specifically in patient with morbid obesity, but to date no randomized trials have been
        conducted to confirm these observations. Furthermore, conclusive data are needed to evaluate
        length of hospitalization, intraoperative and postoperative complications, adherence to the
        MSKCC nodal staging algorithm, and oncological outcomes in this group of patients. Robust
        data in morbidly obese endometrial cancer patients to choose the most appropriate surgical
        technique are missing, particularly in the era of sentinel lymph node. Moreover, conversion
        to laparotomy in the previous study occurred to achieve a complete surgical staging with
        lymphadenectomy. Thus, investigators expect to have a lower conversion rate in this study.
  
        Rationale:
  
        The rationale of the study is to find the most appropriate minimally invasive surgical
        approach in morbidly obese patients with endometrial carcinoma
  
        Objectives:
  
        Primary objective: To evaluate conversion rate to laparotomy with robotic surgery vs
        laparoscopic surgery (laparoscopic surgery referent group)
  
        Secondary objectives:
  
          -  To evaluate difference in overall duration of surgery
  
          -  To evaluate difference in perioperative complications
  
          -  To evaluate the adherence to sentinel lymph node MSKCC algorithm
  
          -  To compare ergonomics of the two different surgical approach
  
          -  To compare quality of life (QoL) at baseline, 1 and 4 weeks (early), and 3 and 6 months
             (late) after surgery, using the Functional Assessment of Cancer Therapy-General (FACT-G)
             questionnaire
  
          -  To assess adherence to ESGO surgical Quality Index (QI, rate of uterine rupture)
  
          -  To evaluate difference in overall survival and disease-free survival
  
        Primary end point: the number of surgical procedures that need a conversion over the total
        number of surgical procedures in the two arms.
  
        Secondary end points:
  
          -  Duration in minutes of surgery
  
          -  Number of patients with at least one perioperative complications measured by Clavien
             Dindo
  
          -  To evaluate the ergonomics through the Rapid Upper Limb Assessment (RULA) assessment
             tool
  
          -  Disease-Free Survival (DFS) defined as the time between randomization and the first
             detection of relapse or death, whichever event occurs first; for patients without events
             DFS will be censored at the date of last follow-up
  
          -  Overall Survival (OS) defined as the time between randomization and death for any cause;
             for alive patients OS will be censored at the date of last follow-up
  
        Study Design: Randomized Controlled Multicentric Superiority trial
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Conversion rate
  time frame: At the end of the enrollment phase
  description: Number of procedures converted to laparotomy from MIS
  measure: Difference in overall duration of surgery
  time frame: At the end of the enrollment phase
  description: Difference in duration of procedures measured in minutes
  measure: Difference in perioperative complications
  time frame: 36 and 72 months
  description: Number of patients with at least one perioperative complications measured by Clavien Dindo
  measure: Adherence to sentinel lymph node MSKCC algorithm
  time frame: At the end of the enrollment phase
  description: Number of case with completed lymph nodal staging according to MSKCC algorithm
  measure: Ergonomics of the two different surgical approach
  time frame: At the end of the enrollment phase
  description: Investigators will evaluate the ergonomics of the two MIS system through the Rapid Upper Limb Assessment (RULA) assessment tool. Rula is aimed to make a rapid assessment on neck and upper limb loading in tasks. The risk of work-related disorders is calculated into a score of 1(low) to 7 (high)
  measure: Quality of life (QoL) at baseline, 1 and 4 weeks (early), and 3 and 6 months (late) after surgery
  time frame: 1 and 4 weeks (early), and 3 and 6 months (late) after surgery
  description: Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire will be used. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure physical, social, emotional, and functional well-being in cancer patients. The score range 0-108; the higher the score, the better the QOL.
  measure: Adherence to ESGO surgical Quality Index
  time frame: 36 and 72 months
  description: Investigators will assess adherence to ESGO surgical Quality Index (QI, rate of uterine rupture)
  measure: Difference in overall survival and disease-free survival
  time frame: 36 and 72 months
  description: Investigators will evaluate difference in Overall Survival, defined as the time between randomization and death for any cause, for alive patients OS will be censored at the date of last follow-up; investigators will evaluate difference in disease-free survival, defined as the time between randomization and the first detection of relapse or death, whichever event occurs first; for patients without events DFS will be censored at the date of last follow-up
  arm group label: Robotic surgery
  arm group type: Experimental
  arm group label: Laparoscopic surgery
  arm group type: Active Comparator
  intervention type: Procedure
  intervention name: Robot-assisted surgery
  description: Total hysterectomy with bilateral salpingo-oophorectomy and lymphnodes staging using DaVinci Xi
  arm group label: Robotic surgery
  intervention type: Procedure
  intervention name: Laparoscopic surgery
  description: Total hysterectomy with bilateral salpingo-oophorectomy and lymph nodes staging using standard laparoscopic approach
  arm group label: Laparoscopic surgery
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Francesco Fanfani, MD
  role: Principal Investigator
  affiliation: Policlinico Gemelli IRCCS
  last name: Francesco Fanfani, MD
  phone: 0630153421
  email: francesco.fanfani@policlinicogemelli.it
  responsible party type: Principal Investigator
  investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  investigator full name: Fanfani Francesco
  investigator title: Professor
  mesh term: Endometrial Neoplasms
  mesh term: Genital Diseases, Female
  mesh term: Obesity, Morbid
  provided document: 