<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/NCT03824054</url>
  </required_header>
  <id_info>
    <org_study_id>CICOG-31-10-18\100</org_study_id>
    <nct_id>NCT03824054</nct_id>
  </id_info>
  <brief_title>Quality of Life in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis</brief_title>
  <acronym>ENDO-RESECT</acronym>
  <official_title>Evaluation of Quality of Life and Gastrointestinal Well-being in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis. Retrospective Observational Cohort Study</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>No</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>
      The aim of this study is to evaluate the quality of life of patients undergoing colorectal&#xD;
      resection for deep infiltrating endometriosis of the bowel. Questionnaires about pre&#xD;
      operative status have been submitted retrospectively, while post operative questionnaires&#xD;
      have been submitted prospectively during last follow up visit&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients fit for the study will be asked to complete a visual analogue scales (VAS) for&#xD;
      dysmenorrhea, deep dyspaurenia, dysuria, dyschesia and chronic pelvic pain (CPP) Patients&#xD;
      will fill in the Endometriosis QoL Questionnaire (EHP30), the gastrointestinal well-being&#xD;
      questionnaires Bristol Stool Chart, GSCG (Gastrointestinal Symptom Rating Scale), STAY (1 and&#xD;
      2), the Psychological General Well-Being Index (PGWBI), Generalized Self-Efficacy, CD-RISC -&#xD;
      Connor-Davidson scale about their pre operative and actual status.&#xD;
&#xD;
      Surgery includes laparoscopic resection of all visible endometriosis, including resection of&#xD;
      the affected bowel with primary anastomosis Perioperative and post-operative complications&#xD;
      will be collected using the Extended Clavien-Dindo classification of surgical complications&#xD;
      divided in early (within 30 days after surgery onset) and late (over 30 days after surgery&#xD;
      onset).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2005</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pre-post colorectal resection-and-anastomosis evaluation of gastrointestinal symptoms (stipsi, dyschezia, regurgitation, nausea and vomit, abdominal distension and belching)</measure>
    <time_frame>from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)</time_frame>
    <description>Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of stipsi, dyschezia, regurgitation, nausea and vomit, abdominal distension and belching, through the administration of the GSRS (Gastrointestinal Symptom Rating Scale) to patients. The GSRS is a disease-specific instrument that includes 15 items combined into five-symptom clusters addressing different gastrointestinal symptoms. The five-symptom clusters depict reflux, abdominal pain, indigestion, diarrhoea and constipation. The GSRS has a seven-graded scale where 1 represents absence of bothersome symptoms and 7 represents very bothersome symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pre-post colorectal resection-and-anastomosis evaluation of anxiety, depression, positivity and well-being, self control, general health and vitality</measure>
    <time_frame>from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)</time_frame>
    <description>Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of anxiety, depression, positivity and well-being, self control, general health and vitality, through the administration of the PGWBI (Psychological General Well-Being Index) to patients. The PGWBI is a brief self-administered questionnaire which contains 20 items rated on a six-point scale, where a higher score indicates a better quality of life and measures six mood states (anxiety, depressed mood, positive well-being, self-control, general health, vitality). The six mood states are scored as follows: 25 for anxiety, 20 for positive well-being and vitality and 15 for remaining</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-post colorectal resection-and-anastomosis evaluation of the coping ability of daily living</measure>
    <time_frame>from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)</time_frame>
    <description>Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of the coping ability of daily living, through the administration of the GSE (General Self-Efficacy Scale) to patients.&#xD;
The GSE consists of 10 items, with a 4-point Likert scale ranging from 1 (I Completely Disagree) to 4 (I Completely Agree), aimed at identifying, as expressed in the introduction, self-efficacy beliefs in view of difficult situations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-post colorectal-resection-and-anastomosis evaluation of patients ability to &quot;thrive in the face of adversity&quot;</measure>
    <time_frame>from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)</time_frame>
    <description>Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of the ability to &quot;thrive in the face of adversity&quot;, through the administration of the CD-RISC (Connor-Davidson Resilience Scale) to patients.&#xD;
The CD-RISC contains 25 items, all of which carry a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The scale is rated based on how the subject has felt over the past month. The total score ranges from 0-100, with higher scores reflecting greater resilience</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-post colorectal resection-and-anastomosis evaluation of the effects that endometriosis can have on women's lives (includes work and family life, sexual life, fertility issues)</measure>
    <time_frame>from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)</time_frame>
    <description>Pre-post colorectal resection-and-anastomosis evaluation of the effects that endometriosis can have on women's lives (work and family life, sexual life, fertility issues), through the administration of the EHP-30(Endometriosis Health Profile questionnaire).The EHP-30 consists of a 30-item core questionnaire, covers five subscales (11 items on pain, 6 on control and powerlessness, 6 on emotions, 4 on social support, 3 on self-image), and a second 23-item modular questionnaire contains six subscales (5 items on work life, 2 on relationship with children, 5 on sexual intercourse, 4 on medical profession, 3 on treatment and 4 on infertility). Response categories are rated on a five-point Likert scale (0-4), and items within each subscale are summed to create a raw-score.Each raw scale is translated into a score ranging from 0(best possible health status) to 100 by dividing the total raw scores in each subscale by the maximum possible raw-score within the subscale and multiplying it by 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-post colorectal-resection-and-anastomosis evaluation of the menstrual pain</measure>
    <time_frame>from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)</time_frame>
    <description>Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of the menstrual pain, through the administration of the VAS (Visual Analogic Scale) to patients. The VAS using a 10-cm line represented the continuum of the patient's opinion of the degree of pain. One extremity of the line represented &quot;unbearable pain,&quot; and the other extremity represented &quot;no pain at all.&quot; The participants were asked to rate the degree of pain by making a mark on the line. The scores received from the scale were classified into mild dysmenorrhea if it was between 1 and 3 points moderate between 4 and 7 points, and severe between 8 and 10 points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of post-operative complications (rectovaginal fistulae, bowel leakage, pelvic abscesses, and postoperative bleeding)</measure>
    <time_frame>from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)</time_frame>
    <description>Perioperative and post-operative complications were collected using the Extended Clavien-Dindo classification of surgical complications divided in early (within 30 days after surgery onset) and late (over 30 days after surgery onset). Major complications were defined as those requiring surgical, endoscopic, or radiological intervention (grade III or higher according to the Clavien-Dindo classification), and include rectovaginal fistulae, bowel leakage, pelvic abscesses, and postoperative bleeding after surgery. Minor complications were defined as those that could be solved with a conservative approach (Clavien-Dindo grade I and II)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>colorectal resection arm</arm_group_label>
    <description>Patients affected by symptomatic deep infiltrating endometriosis involving the bowel and submitted to colo-rectal resection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>colorectal resection</intervention_name>
    <description>Surgery includes laparoscopic resection of all visible endometriosis, including resection of the affected bowel with primary anastomosis</description>
    <arm_group_label>colorectal resection arm</arm_group_label>
    <other_name>ileostomy creation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients affected by symptomatic deep infiltrating endometriosis involving the bowel and&#xD;
        candidate to colo-rectal resection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged between 18 and 45 years&#xD;
&#xD;
          -  Clinical diagnosis of deep endometriosis infiltrating the bowel&#xD;
&#xD;
          -  Women undergoing surgical removal with colorectal resection with or without loop&#xD;
             ileostomy creation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of previous or ongoing neoplastic pathology&#xD;
&#xD;
          -  Contraindications to surgical intervention&#xD;
&#xD;
          -  Not complete eradicating surgery&#xD;
&#xD;
          -  Psychiatric disorders&#xD;
&#xD;
          -  Surgical, spontaneous or pharmacological menopause - Intestinal surgery different from&#xD;
             segmental bowel resection and colorectal anastomosis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francesco Cosentino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>francesco.cosentino@fgps.it</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Catholic University of Sacred Heart</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>March 27, 2019</last_update_submitted>
  <last_update_submitted_qc>March 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</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>Professor</investigator_title>
  </responsible_party>
  <keyword>deep infiltrating endometriosis</keyword>
  <keyword>colorectal resection</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</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/NCT03824054
org study id: CICOG-31-10-18\100
nct id: NCT03824054
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the quality of life of patients undergoing colorectal
      resection for deep infiltrating endometriosis of the bowel. Questionnaires about pre
      operative status have been submitted retrospectively, while post operative questionnaires
      have been submitted prospectively during last follow up visit
All patients fit for the study will be asked to complete a visual analogue scales (VAS) for
      dysmenorrhea, deep dyspaurenia, dysuria, dyschesia and chronic pelvic pain (CPP) Patients
      will fill in the Endometriosis QoL Questionnaire (EHP30), the gastrointestinal well-being
      questionnaires Bristol Stool Chart, GSCG (Gastrointestinal Symptom Rating Scale), STAY (1 and
      2), the Psychological General Well-Being Index (PGWBI), Generalized Self-Efficacy, CD-RISC -
      Connor-Davidson scale about their pre operative and actual status.

      Surgery includes laparoscopic resection of all visible endometriosis, including resection of
      the affected bowel with primary anastomosis Perioperative and post-operative complications
      will be collected using the Extended Clavien-Dindo classification of surgical complications
      divided in early (within 30 days after surgery onset) and late (over 30 days after surgery
      onset).
observational model: Cohort
time perspective: Retrospective
measure: Pre-post colorectal resection-and-anastomosis evaluation of gastrointestinal symptoms (stipsi, dyschezia, regurgitation, nausea and vomit, abdominal distension and belching)
time frame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
description: Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of stipsi, dyschezia, regurgitation, nausea and vomit, abdominal distension and belching, through the administration of the GSRS (Gastrointestinal Symptom Rating Scale) to patients. The GSRS is a disease-specific instrument that includes 15 items combined into five-symptom clusters addressing different gastrointestinal symptoms. The five-symptom clusters depict reflux, abdominal pain, indigestion, diarrhoea and constipation. The GSRS has a seven-graded scale where 1 represents absence of bothersome symptoms and 7 represents very bothersome symptoms
measure: Pre-post colorectal resection-and-anastomosis evaluation of anxiety, depression, positivity and well-being, self control, general health and vitality
time frame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
description: Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of anxiety, depression, positivity and well-being, self control, general health and vitality, through the administration of the PGWBI (Psychological General Well-Being Index) to patients. The PGWBI is a brief self-administered questionnaire which contains 20 items rated on a six-point scale, where a higher score indicates a better quality of life and measures six mood states (anxiety, depressed mood, positive well-being, self-control, general health, vitality). The six mood states are scored as follows: 25 for anxiety, 20 for positive well-being and vitality and 15 for remaining
measure: Pre-post colorectal resection-and-anastomosis evaluation of the coping ability of daily living
time frame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
description: Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of the coping ability of daily living, through the administration of the GSE (General Self-Efficacy Scale) to patients.
The GSE consists of 10 items, with a 4-point Likert scale ranging from 1 (I Completely Disagree) to 4 (I Completely Agree), aimed at identifying, as expressed in the introduction, self-efficacy beliefs in view of difficult situations
measure: Pre-post colorectal-resection-and-anastomosis evaluation of patients ability to "thrive in the face of adversity"
time frame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
description: Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of the ability to "thrive in the face of adversity", through the administration of the CD-RISC (Connor-Davidson Resilience Scale) to patients.
The CD-RISC contains 25 items, all of which carry a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The scale is rated based on how the subject has felt over the past month. The total score ranges from 0-100, with higher scores reflecting greater resilience
measure: Pre-post colorectal resection-and-anastomosis evaluation of the effects that endometriosis can have on women's lives (includes work and family life, sexual life, fertility issues)
time frame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
description: Pre-post colorectal resection-and-anastomosis evaluation of the effects that endometriosis can have on women's lives (work and family life, sexual life, fertility issues), through the administration of the EHP-30(Endometriosis Health Profile questionnaire).The EHP-30 consists of a 30-item core questionnaire, covers five subscales (11 items on pain, 6 on control and powerlessness, 6 on emotions, 4 on social support, 3 on self-image), and a second 23-item modular questionnaire contains six subscales (5 items on work life, 2 on relationship with children, 5 on sexual intercourse, 4 on medical profession, 3 on treatment and 4 on infertility). Response categories are rated on a five-point Likert scale (0-4), and items within each subscale are summed to create a raw-score.Each raw scale is translated into a score ranging from 0(best possible health status) to 100 by dividing the total raw scores in each subscale by the maximum possible raw-score within the subscale and multiplying it by 100
measure: Pre-post colorectal-resection-and-anastomosis evaluation of the menstrual pain
time frame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
description: Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of the menstrual pain, through the administration of the VAS (Visual Analogic Scale) to patients. The VAS using a 10-cm line represented the continuum of the patient's opinion of the degree of pain. One extremity of the line represented "unbearable pain," and the other extremity represented "no pain at all." The participants were asked to rate the degree of pain by making a mark on the line. The scores received from the scale were classified into mild dysmenorrhea if it was between 1 and 3 points moderate between 4 and 7 points, and severe between 8 and 10 points
measure: Prevalence of post-operative complications (rectovaginal fistulae, bowel leakage, pelvic abscesses, and postoperative bleeding)
time frame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)
description: Perioperative and post-operative complications were collected using the Extended Clavien-Dindo classification of surgical complications divided in early (within 30 days after surgery onset) and late (over 30 days after surgery onset). Major complications were defined as those requiring surgical, endoscopic, or radiological intervention (grade III or higher according to the Clavien-Dindo classification), and include rectovaginal fistulae, bowel leakage, pelvic abscesses, and postoperative bleeding after surgery. Minor complications were defined as those that could be solved with a conservative approach (Clavien-Dindo grade I and II)
arm group label: colorectal resection arm
description: Patients affected by symptomatic deep infiltrating endometriosis involving the bowel and submitted to colo-rectal resection
intervention type: Procedure
intervention name: colorectal resection
description: Surgery includes laparoscopic resection of all visible endometriosis, including resection of the affected bowel with primary anastomosis
arm group label: colorectal resection arm
other name: ileostomy creation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Francesco Cosentino, MD
role: Principal Investigator
affiliation: francesco.cosentino@fgps.it
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Catholic University of the Sacred Heart
investigator full name: Prof. Giovanni Scambia
investigator title: Professor
mesh term: Endometriosis
sharing ipd: Undecided