<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/NCT04404673</url>
  </required_header>
  <id_info>
    <org_study_id>2987</org_study_id>
    <nct_id>NCT04404673</nct_id>
  </id_info>
  <brief_title>Urinary and Sexual Dysfunctions Evaluation After Rectal Resection</brief_title>
  <acronym>EURECA</acronym>
  <official_title>Multicenter Prospective Evaluation of Urinary and Sexual Dysfunctions After Rectal Cancer Resection</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>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Advances in the treatment of rectal cancer over the past two decades have improved survival&#xD;
      and significantly reduced surgery-related morbidity. As a result, post-treatment quality of&#xD;
      life (QoL) issues have become increasingly important. Urinary and sexual functions can be&#xD;
      significantly altered after rectal resection, mainly due to the iatrogenic lesions of the&#xD;
      pelvic autonomous lexus. Of note, their incidence is reported up to 70% and 30%,&#xD;
      respectively. Despite the importance of this topic, most of the studies present in the&#xD;
      literature are difficult to interpret for a variety of reasons. Firstly, both sexual and&#xD;
      urinary dysfunctions lack a standardized definition. Secondly, the absence of baseline data,&#xD;
      missing data, small sample sizes, and heterogeneity in the use of validated and nonvalidated&#xD;
      instruments are the main limitation in drawing conclusive results. As additional factor, no&#xD;
      clear evidence is present in the literature regarding the best approach to be used in order&#xD;
      to preserve as much as possible both the sexual and urinary functionalities and to guarantee,&#xD;
      at the same time, an adequate and oncologically correct rectal resection. Moreover, no data&#xD;
      are currently present regarding the impact of pre-operative chemo-radiotherapy on the urinary&#xD;
      and sexual functionalities. The main objective of the investigator's prospective study will&#xD;
      be to define in a subjective manner which technique (open, laparoscopic, robot-assisted and&#xD;
      Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or&#xD;
      without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas.&#xD;
&#xD;
      Thus, the primary endpoint will the post-operative evaluation at 1, 6 months and 1 year of&#xD;
      the urinary and sexual functions by means of specific questionnaires.&#xD;
&#xD;
      Secondary endpoints will be:&#xD;
&#xD;
        -  to investigate which technique (open, robotic, laparoscopic and trans-anal total&#xD;
           mesorectal excision (TaTME)) more favorably correlate with urinary and sexual functions&#xD;
           after radiochemotherapy (NAD+);&#xD;
&#xD;
        -  the comparison of both the urinary and sexual dysfunction incidence on the base of the&#xD;
           distance of the rectal tumor from the anal verge and the evaluation of the best approach&#xD;
           to be used (open, laparoscopic, TaTME or robot-assisted) in relation to the tumor&#xD;
           height;&#xD;
&#xD;
        -  the short- (postoperative morbidity and histopathological data) and long-term (overall&#xD;
           and disease-free survival) outcomes comparison among the open, laparoscopic, TaTME and&#xD;
           robotic rectal resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 21, 2020</start_date>
  <completion_date type="Anticipated">February 20, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 20, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary and sexual outcomes after rectal resection</measure>
    <time_frame>At 1 month after surgery</time_frame>
    <description>Which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary and sexual outcomes after rectal resection</measure>
    <time_frame>At 6 months after surgery</time_frame>
    <description>Which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary and sexual outcomes after rectal resection</measure>
    <time_frame>At 12 months after surgery</time_frame>
    <description>Which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">1172</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Open rectal resection</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic rectal resection</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Robotic rectal resection</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Trans-anal TME (Ta-TME)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Evaluation of urinary and sexual dysfunction after rectal resection</intervention_name>
    <description>Comparison among the 4 different surgical approaches for urinary and sexual function</description>
    <arm_group_label>Laparoscopic rectal resection</arm_group_label>
    <arm_group_label>Open rectal resection</arm_group_label>
    <arm_group_label>Robotic rectal resection</arm_group_label>
    <arm_group_label>Trans-anal TME (Ta-TME)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with a diagnosis of rectal cancer referred to one of the centers involved in&#xD;
        the study during the study period&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with a histopathological proven diagnosis of rectal carcinoma undergoing&#xD;
             curative surgical resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged &lt; 18 years&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Emergent surgeries&#xD;
&#xD;
          -  Previous prostatic and/or colorectal surgery for benign or malignant diseases&#xD;
&#xD;
          -  Preoperative sexual disorders (Female Sexual Function Index, FSFI ≤ 26.55 ;&#xD;
             International Index Erectile Function , IIEF &lt; 16)&#xD;
&#xD;
          -  International Consultation on Incontinence Questionnaire &gt; 5&#xD;
&#xD;
          -  Clinically evident Benign Prostatic Hypertrophy (BPH) (International Prostatic&#xD;
             Symptoms Score, IPSS &gt; 20)&#xD;
&#xD;
          -  Preoperative diagnosis of fecal and/or urinary incontinence.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sergio Alfieri, MD</last_name>
    <phone>+393386792010</phone>
    <email>giuseppe.quero@policlinicogemelli.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sergio Alfieri, MD</last_name>
      <phone>+393386792010</phone>
      <email>giuseppe.quero@policlinicogemelli.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urinary dysfunction</keyword>
  <keyword>Sexual dysfunction</keyword>
  <keyword>Rectal surgery</keyword>
  <keyword>Minimally invasive surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04404673
org study id: 2987
nct id: NCT04404673
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Advances in the treatment of rectal cancer over the past two decades have improved survival
      and significantly reduced surgery-related morbidity. As a result, post-treatment quality of
      life (QoL) issues have become increasingly important. Urinary and sexual functions can be
      significantly altered after rectal resection, mainly due to the iatrogenic lesions of the
      pelvic autonomous lexus. Of note, their incidence is reported up to 70% and 30%,
      respectively. Despite the importance of this topic, most of the studies present in the
      literature are difficult to interpret for a variety of reasons. Firstly, both sexual and
      urinary dysfunctions lack a standardized definition. Secondly, the absence of baseline data,
      missing data, small sample sizes, and heterogeneity in the use of validated and nonvalidated
      instruments are the main limitation in drawing conclusive results. As additional factor, no
      clear evidence is present in the literature regarding the best approach to be used in order
      to preserve as much as possible both the sexual and urinary functionalities and to guarantee,
      at the same time, an adequate and oncologically correct rectal resection. Moreover, no data
      are currently present regarding the impact of pre-operative chemo-radiotherapy on the urinary
      and sexual functionalities. The main objective of the investigator's prospective study will
      be to define in a subjective manner which technique (open, laparoscopic, robot-assisted and
      Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or
      without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas.

      Thus, the primary endpoint will the post-operative evaluation at 1, 6 months and 1 year of
      the urinary and sexual functions by means of specific questionnaires.

      Secondary endpoints will be:

        -  to investigate which technique (open, robotic, laparoscopic and trans-anal total
           mesorectal excision (TaTME)) more favorably correlate with urinary and sexual functions
           after radiochemotherapy (NAD+);

        -  the comparison of both the urinary and sexual dysfunction incidence on the base of the
           distance of the rectal tumor from the anal verge and the evaluation of the best approach
           to be used (open, laparoscopic, TaTME or robot-assisted) in relation to the tumor
           height;

        -  the short- (postoperative morbidity and histopathological data) and long-term (overall
           and disease-free survival) outcomes comparison among the open, laparoscopic, TaTME and
           robotic rectal resection.
observational model: Case-Control
time perspective: Prospective
measure: Urinary and sexual outcomes after rectal resection
time frame: At 1 month after surgery
description: Which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas
measure: Urinary and sexual outcomes after rectal resection
time frame: At 6 months after surgery
description: Which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas
measure: Urinary and sexual outcomes after rectal resection
time frame: At 12 months after surgery
description: Which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas
arm group label: Open rectal resection
arm group label: Laparoscopic rectal resection
arm group label: Robotic rectal resection
arm group label: Trans-anal TME (Ta-TME)
intervention type: Procedure
intervention name: Evaluation of urinary and sexual dysfunction after rectal resection
description: Comparison among the 4 different surgical approaches for urinary and sexual function
arm group label: Laparoscopic rectal resection
arm group label: Open rectal resection
arm group label: Robotic rectal resection
arm group label: Trans-anal TME (Ta-TME)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sergio Alfieri, MD
phone: +393386792010
email: giuseppe.quero@policlinicogemelli.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor
mesh term: Rectal Neoplasms
sharing ipd: Undecided