<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/NCT03292289</url>
  </required_header>
  <id_info>
    <org_study_id>QUALIPRO-1703</org_study_id>
    <secondary_id>2017-A01406-47</secondary_id>
    <nct_id>NCT03292289</nct_id>
  </id_info>
  <brief_title>Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction</brief_title>
  <acronym>QUALIPRO</acronym>
  <official_title>Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Oscar Lambret</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Santelys Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Groupement Interrégional de Recherche Clinique et d'Innovation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Oscar Lambret</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>
      This study is a prospective, monocentric study whose aim is to assess the quality of life for&#xD;
      patients who underwent a coloanal continuity reconstruction and to understand the functional&#xD;
      issues they encounter. This will potentially provide predictive factors identification of bad&#xD;
      functional outcomes allowing to guide future decisions. Also, it will allow patients to have&#xD;
      a reinforced follow-up during the year after the reconstruction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      First of all, an information document will be given to the patients and their consent will be&#xD;
      collected. Then, they will be registered through the online eCRF (or by FAX) and a study&#xD;
      number will be given to each patient.&#xD;
&#xD;
      The study will proceed with 2 stomatherapy consultations at one and six months after coloanal&#xD;
      continuity reconstruction. Patient care and following up will proceed as usual. The&#xD;
      stomatherapy consultation will be done by a qualified nurse.&#xD;
&#xD;
      Before the 1st intervention (proctectomy):&#xD;
&#xD;
        -  Collect of clinical data and disease history&#xD;
&#xD;
        -  Quality of life questionnaires (EORTC-QLQ-C30 and CR29)&#xD;
&#xD;
        -  Evaluation of LARS score&#xD;
&#xD;
      After the 1st intervention (proctectomy, at month 1):&#xD;
&#xD;
      - Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL&#xD;
&#xD;
      Before the 2nd intervention (coloanal continuity reconstruction):&#xD;
&#xD;
      - Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL&#xD;
&#xD;
      After the 2nd intervention (at month 1, month 3, month 6 and one year):&#xD;
&#xD;
        -  at 1 and 6 months : clinical exam (stomatherapy consultation) for collect of&#xD;
           postoperative complications&#xD;
&#xD;
        -  Quality of life : EORTC-QLC30 and CR-29 questionnaires and LARS score&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 16, 2018</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">February 16, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life 1 year after the second intervention, using LARS score</measure>
    <time_frame>from baseline to 1 year after the second intervention</time_frame>
    <description>Obtain an objective assessment of symptoms intensity (using the LARS score)for patients who received a proctectomy for rectal cancer (&quot;1st intervention&quot;) following by a coloanal continuity reconstruction (&quot;2nd intervention&quot;)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life before the first intervention and after the second intervention</measure>
    <time_frame>from baseline to one year after the 2nd intervention</time_frame>
    <description>Obtain an objective assessment of symptoms intensity (using the LARS score)for patients who received a proctectomy for rectal cancer (&quot;1st intervention&quot;) following by a coloanal continuity reconstruction (&quot;2nd intervention&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life using EORTC-QLQ-C30</measure>
    <time_frame>from baseline to one year after the 2nd intervention</time_frame>
    <description>Assess the quality of life using EORTC-QLQ-C30 questionnaires before the first intervention, between the first and the second intervention and after the second intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life using EORTC-QLQ-CR29 questionnaires</measure>
    <time_frame>from baseline to one year after the 2nd intervention</time_frame>
    <description>Assess the quality of life using EORTC-QLQ- CR29 questionnaires before the first intervention, between the first and the second intervention and after the second intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of stomy on quality of life</measure>
    <time_frame>from the first intervention to 6 months after the first intervention</time_frame>
    <description>Assess the impact of stomy on quality of life for patients who received a proctectomy for rectal cancer and using Stoma-QoL questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with anastomotic fistula</measure>
    <time_frame>from the first intervention to 6 months after the first intervention</time_frame>
    <description>Determinate the rate of patients with anastomotic fistula requiring the conservation of the stomy, and so they cannot undergo a coloanal continuity reconstruction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical complications description</measure>
    <time_frame>from first intervention to one year after the 2nd intervention</time_frame>
    <description>Describe surgical complications linked to the coloanal continuity reconstruction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of patients with a second stoma placement, using EORTC-QLQ-CR29 questionnaires</measure>
    <time_frame>From the 2nd intervention to one year after the 2nd intervention</time_frame>
    <description>Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of patients with a second stoma placement, using EORTC-QLQ-C30 questionnaires</measure>
    <time_frame>From the 2nd intervention to one year after the 2nd intervention</time_frame>
    <description>Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of patients with a second stoma placement, using LARS score</measure>
    <time_frame>From the 2nd intervention to one year after the 2nd intervention</time_frame>
    <description>Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">65</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Study process</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pre- and post-operative consultation</intervention_name>
    <description>Before and between the two interventions</description>
    <arm_group_label>Study process</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stomatherapy consultation</intervention_name>
    <description>Clinical exam. At one and six months after the 2nd intervention</description>
    <arm_group_label>Study process</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>QLQ-C30 and QLQ-CR29 at each time defined by the study (one month before and after the first intervention, before the 2nd intervention and at 1, 3, 6 and 12 months after the 2nd intervention)&#xD;
Stoma-QoL before and after the 2nd intervention&#xD;
LARS score at 1, 3, 6 and 12 months after the 2nd intervention</description>
    <arm_group_label>Study process</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 70 years old&#xD;
&#xD;
          -  Patients who are going to undergo a proctectomy for a rectal cancer (situated at a&#xD;
             distance equal or lower to 15 cm from the anoderm) following by a coloanal continuity&#xD;
             reconstruction (using direct, latero-terminal or colonic J-pouch anastomosis)&#xD;
&#xD;
          -  Already underwent or not a neoadjuvant radio-chemotherapy&#xD;
&#xD;
          -  Affiliation to the National Social Security System&#xD;
&#xD;
          -  With informed and signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling patients&#xD;
&#xD;
          -  Patient deprived of their liberty or under guardianship or tutorship.&#xD;
&#xD;
          -  Abdominal perineal amputation&#xD;
&#xD;
          -  No stoma placement planned&#xD;
&#xD;
          -  Tumor more than 15 cm from the anal margin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pascale COULON</last_name>
    <role>Study Director</role>
    <affiliation>Centre Oscar Lambret</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>proctectomy</keyword>
  <keyword>coloanal continuity reconstruction</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>No</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/NCT03292289
org study id: QUALIPRO-1703
secondary id: 2017-A01406-47
nct id: NCT03292289
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, monocentric study whose aim is to assess the quality of life for
      patients who underwent a coloanal continuity reconstruction and to understand the functional
      issues they encounter. This will potentially provide predictive factors identification of bad
      functional outcomes allowing to guide future decisions. Also, it will allow patients to have
      a reinforced follow-up during the year after the reconstruction.
First of all, an information document will be given to the patients and their consent will be
      collected. Then, they will be registered through the online eCRF (or by FAX) and a study
      number will be given to each patient.

      The study will proceed with 2 stomatherapy consultations at one and six months after coloanal
      continuity reconstruction. Patient care and following up will proceed as usual. The
      stomatherapy consultation will be done by a qualified nurse.

      Before the 1st intervention (proctectomy):

        -  Collect of clinical data and disease history

        -  Quality of life questionnaires (EORTC-QLQ-C30 and CR29)

        -  Evaluation of LARS score

      After the 1st intervention (proctectomy, at month 1):

      - Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL

      Before the 2nd intervention (coloanal continuity reconstruction):

      - Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL

      After the 2nd intervention (at month 1, month 3, month 6 and one year):

        -  at 1 and 6 months : clinical exam (stomatherapy consultation) for collect of
           postoperative complications

        -  Quality of life : EORTC-QLC30 and CR-29 questionnaires and LARS score
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Quality of life 1 year after the second intervention, using LARS score
time frame: from baseline to 1 year after the second intervention
description: Obtain an objective assessment of symptoms intensity (using the LARS score)for patients who received a proctectomy for rectal cancer ("1st intervention") following by a coloanal continuity reconstruction ("2nd intervention")
measure: Quality of life before the first intervention and after the second intervention
time frame: from baseline to one year after the 2nd intervention
description: Obtain an objective assessment of symptoms intensity (using the LARS score)for patients who received a proctectomy for rectal cancer ("1st intervention") following by a coloanal continuity reconstruction ("2nd intervention")
measure: Quality of life using EORTC-QLQ-C30
time frame: from baseline to one year after the 2nd intervention
description: Assess the quality of life using EORTC-QLQ-C30 questionnaires before the first intervention, between the first and the second intervention and after the second intervention
measure: Quality of life using EORTC-QLQ-CR29 questionnaires
time frame: from baseline to one year after the 2nd intervention
description: Assess the quality of life using EORTC-QLQ- CR29 questionnaires before the first intervention, between the first and the second intervention and after the second intervention
measure: Impact of stomy on quality of life
time frame: from the first intervention to 6 months after the first intervention
description: Assess the impact of stomy on quality of life for patients who received a proctectomy for rectal cancer and using Stoma-QoL questionnaire
measure: Rate of patients with anastomotic fistula
time frame: from the first intervention to 6 months after the first intervention
description: Determinate the rate of patients with anastomotic fistula requiring the conservation of the stomy, and so they cannot undergo a coloanal continuity reconstruction
measure: Surgical complications description
time frame: from first intervention to one year after the 2nd intervention
description: Describe surgical complications linked to the coloanal continuity reconstruction
measure: Quality of life of patients with a second stoma placement, using EORTC-QLQ-CR29 questionnaires
time frame: From the 2nd intervention to one year after the 2nd intervention
description: Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .
measure: Quality of life of patients with a second stoma placement, using EORTC-QLQ-C30 questionnaires
time frame: From the 2nd intervention to one year after the 2nd intervention
description: Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .
measure: Quality of life of patients with a second stoma placement, using LARS score
time frame: From the 2nd intervention to one year after the 2nd intervention
description: Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .
arm group label: Study process
arm group type: Experimental
description: Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires
intervention type: Procedure
intervention name: Pre- and post-operative consultation
description: Before and between the two interventions
arm group label: Study process
intervention type: Procedure
intervention name: Stomatherapy consultation
description: Clinical exam. At one and six months after the 2nd intervention
arm group label: Study process
intervention type: Procedure
intervention name: Questionnaires
description: QLQ-C30 and QLQ-CR29 at each time defined by the study (one month before and after the first intervention, before the 2nd intervention and at 1, 3, 6 and 12 months after the 2nd intervention)
Stoma-QoL before and after the 2nd intervention
LARS score at 1, 3, 6 and 12 months after the 2nd intervention
arm group label: Study process
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Pascale COULON
role: Study Director
affiliation: Centre Oscar Lambret
facility: 
country: France
responsible party type: Sponsor
mesh term: Rectal Neoplasms
sharing ipd: No