<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/NCT03307824</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0647</org_study_id>
    <secondary_id>2017-A01405-48</secondary_id>
    <nct_id>NCT03307824</nct_id>
  </id_info>
  <brief_title>Operative Time During the Use of the Synthetic Glue IFABONDTM in Laparoscopic Sacrocolpopexy</brief_title>
  <acronym>Procolle 2</acronym>
  <official_title>A Multicenter Randomized Study on Operative Time When Using IFABOND™ Synthetic Glue in Laparoscopic Sacrocolpopexy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Laparoscopic sacrocolpopexy has now become the gold standard technique for correction of&#xD;
      anterior and apical prolapse. In order to provide an alternative to stapling system and&#xD;
      sutures involving vaginal erosion and shrinkage phenomena, there is a technique to fix&#xD;
      material meshes by the use of a liquid, tissue, synthetic adhesive and sterile. The&#xD;
      investigator hypothesizes that the use of IFABOND ™ adhesive in laparoscopic sacrocolpopexy&#xD;
      significantly reduces the time of surgery compared to the classic suture technique. The&#xD;
      prospective, randomized, multicenter study therefore aims to compare the time of surgery when&#xD;
      using the IFABOND™ synthetic adhesive and the technique by sutures to fix material meshes in&#xD;
      laparoscopic sacrocolpopexy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 20, 2017</start_date>
  <completion_date type="Anticipated">November 20, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 20, 2024</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>duration of surgery</measure>
    <time_frame>Day 0</time_frame>
    <description>time of surgery in minutes (measured by chronometers)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage prolapse correction failure</measure>
    <time_frame>at 1 months post-surgery</time_frame>
    <description>A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage prolapse correction failure</measure>
    <time_frame>at 12 months post-surgery</time_frame>
    <description>A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage prolapse correction failure</measure>
    <time_frame>at 24 months post-surgery</time_frame>
    <description>A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complications</measure>
    <time_frame>at day 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complications</measure>
    <time_frame>at 1 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complications</measure>
    <time_frame>at 12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complications</measure>
    <time_frame>at 24 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain</measure>
    <time_frame>at day 0</time_frame>
    <description>assessed by visual analog scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain</measure>
    <time_frame>at 1 months post-surgery</time_frame>
    <description>assessed by visual analog scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain</measure>
    <time_frame>at 12 months post-surgery</time_frame>
    <description>assessed by visual analog scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain</measure>
    <time_frame>at 24 months post-surgery</time_frame>
    <description>assessed by visual analog scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 1 months post-surgery</time_frame>
    <description>assessed by the questionnaires Short Form Health Survey-12 (SF-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 1 months post-surgery</time_frame>
    <description>assessed by the questionnaires Pelvic Floor Distress Inventory -20 (PFDI-20)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 1 months post-surgery</time_frame>
    <description>assessed by the questionnaires Pelvic Floor Impact Questionnaire-7 (PFIQ-7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 1 months post-surgery</time_frame>
    <description>assessed by the questionnaires Patient Global Impression of Improvement (PGI-I)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 12 months post-surgery</time_frame>
    <description>assessed by the questionnaires SF-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 12 months post-surgery</time_frame>
    <description>assessed by the questionnaires PFDI-20</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 12 months post-surgery</time_frame>
    <description>assessed by the questionnaires PFIQ-7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 12 months post-surgery</time_frame>
    <description>assessed by the questionnaires PGI-I</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 24 months post-surgery</time_frame>
    <description>assessed by the questionnaires SF-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 24 months post-surgery</time_frame>
    <description>assessed by the questionnaires PFDI-20</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 24 months post-surgery</time_frame>
    <description>assessed by the questionnaires PFIQ-7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 24 months post-surgery</time_frame>
    <description>assessed by the questionnaires PGI-I</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sexuality score</measure>
    <time_frame>at 1 months post-surgery</time_frame>
    <description>assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sexuality score</measure>
    <time_frame>at 12 months post-surgery</time_frame>
    <description>assessed by the questionnaire PISQ-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sexuality score</measure>
    <time_frame>at 24 months post-surgery</time_frame>
    <description>assessed by the questionnaire PISQ-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of dyspareunia</measure>
    <time_frame>at 1 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of dyspareunia</measure>
    <time_frame>at 12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of dyspareunia</measure>
    <time_frame>at 24 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of urinary incontinence</measure>
    <time_frame>at 1 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of urinary incontinence</measure>
    <time_frame>at 12 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of urinary incontinence</measure>
    <time_frame>at 24 months post-surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Prolapse</condition>
  <arm_group>
    <arm_group_label>IfabondTM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of the synthetic glue IfabondTM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sutures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Glue-Free Suture Technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Synthetic glue IfabondTM</intervention_name>
    <description>Use of the synthetic glue IfabondTM</description>
    <arm_group_label>IfabondTM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Glue-Free Suture Technique</intervention_name>
    <description>Suture Technique</description>
    <arm_group_label>sutures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman aged 18 years or more&#xD;
&#xD;
          -  Stage III or IV medial and/or anterior genital prolapse on the Pelvic Organ Prolapse&#xD;
             Quantification (POP-Q) classification (hysterocele and/or cystocele) requiring&#xD;
             surgical correction&#xD;
&#xD;
          -  Patient requesting surgery for the trouble caused by the prolapse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prolapse of POP-Q stage &lt;III or without functional impact&#xD;
&#xD;
          -  Unacceptable postoperative risk disclosed on interview: coagulation disorder, immune&#xD;
             disorder, evolutive disease, etc.&#xD;
&#xD;
          -  Impaired lower-limb range of motion preventing positioning for surgery&#xD;
&#xD;
          -  Pregnancy or intended pregnancy during study period&#xD;
&#xD;
          -  Evolutive or latent infection or signs of tissue necrosis on clinical examination&#xD;
&#xD;
          -  Non-controlled diabetes (glycated haemoglobin &gt;8%)&#xD;
&#xD;
          -  Treatment impacting immune response (immunomodulators), ongoing or within previous&#xD;
             month&#xD;
&#xD;
          -  History of pelvic region radiation therapy, at any time&#xD;
&#xD;
          -  History of pelvic cancer&#xD;
&#xD;
          -  Non-controlled evolutive spinal pathology&#xD;
&#xD;
          -  Known hypersensitivity to one of the implant components (polypropylene)&#xD;
&#xD;
          -  Cyanoacrylate hypersensitivity&#xD;
&#xD;
          -  Formaldehyde hypersensitivity&#xD;
&#xD;
          -  Inability to understand information provided&#xD;
&#xD;
          -  No national health insurance cover; prisoner, or ward of court&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Géry LAMBLIN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynaecology Department, Hôpital Femme Mère Enfant, HCL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gynaecology Department, Hôpital Femme Mère Enfant</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>January 13, 2022</last_update_submitted>
  <last_update_submitted_qc>January 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Laparoscopic Surgery</keyword>
  <keyword>synthetic glue IFABONDTM</keyword>
  <keyword>time of surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</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/NCT03307824
org study id: 69HCL16_0647
secondary id: 2017-A01405-48
nct id: NCT03307824
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Laparoscopic sacrocolpopexy has now become the gold standard technique for correction of
      anterior and apical prolapse. In order to provide an alternative to stapling system and
      sutures involving vaginal erosion and shrinkage phenomena, there is a technique to fix
      material meshes by the use of a liquid, tissue, synthetic adhesive and sterile. The
      investigator hypothesizes that the use of IFABOND ™ adhesive in laparoscopic sacrocolpopexy
      significantly reduces the time of surgery compared to the classic suture technique. The
      prospective, randomized, multicenter study therefore aims to compare the time of surgery when
      using the IFABOND™ synthetic adhesive and the technique by sutures to fix material meshes in
      laparoscopic sacrocolpopexy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: duration of surgery
time frame: Day 0
description: time of surgery in minutes (measured by chronometers)
measure: Percentage prolapse correction failure
time frame: at 1 months post-surgery
description: A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
measure: Percentage prolapse correction failure
time frame: at 12 months post-surgery
description: A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
measure: Percentage prolapse correction failure
time frame: at 24 months post-surgery
description: A correction failure correspond to a patient with stage ≥ II prolapse on the POP-Q classification
measure: complications
time frame: at day 0
measure: complications
time frame: at 1 months post-surgery
measure: complications
time frame: at 12 months post-surgery
measure: complications
time frame: at 24 months post-surgery
measure: pain
time frame: at day 0
description: assessed by visual analog scale (VAS)
measure: pain
time frame: at 1 months post-surgery
description: assessed by visual analog scale (VAS)
measure: pain
time frame: at 12 months post-surgery
description: assessed by visual analog scale (VAS)
measure: pain
time frame: at 24 months post-surgery
description: assessed by visual analog scale (VAS)
measure: quality of life
time frame: at 1 months post-surgery
description: assessed by the questionnaires Short Form Health Survey-12 (SF-12)
measure: quality of life
time frame: at 1 months post-surgery
description: assessed by the questionnaires Pelvic Floor Distress Inventory -20 (PFDI-20)
measure: quality of life
time frame: at 1 months post-surgery
description: assessed by the questionnaires Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
measure: quality of life
time frame: at 1 months post-surgery
description: assessed by the questionnaires Patient Global Impression of Improvement (PGI-I)
measure: quality of life
time frame: at 12 months post-surgery
description: assessed by the questionnaires SF-12
measure: quality of life
time frame: at 12 months post-surgery
description: assessed by the questionnaires PFDI-20
measure: quality of life
time frame: at 12 months post-surgery
description: assessed by the questionnaires PFIQ-7
measure: quality of life
time frame: at 12 months post-surgery
description: assessed by the questionnaires PGI-I
measure: quality of life
time frame: at 24 months post-surgery
description: assessed by the questionnaires SF-12
measure: quality of life
time frame: at 24 months post-surgery
description: assessed by the questionnaires PFDI-20
measure: quality of life
time frame: at 24 months post-surgery
description: assessed by the questionnaires PFIQ-7
measure: quality of life
time frame: at 24 months post-surgery
description: assessed by the questionnaires PGI-I
measure: sexuality score
time frame: at 1 months post-surgery
description: assessed by the questionnaire french version of Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12)
measure: sexuality score
time frame: at 12 months post-surgery
description: assessed by the questionnaire PISQ-12
measure: sexuality score
time frame: at 24 months post-surgery
description: assessed by the questionnaire PISQ-12
measure: percentage of dyspareunia
time frame: at 1 months post-surgery
measure: percentage of dyspareunia
time frame: at 12 months post-surgery
measure: percentage of dyspareunia
time frame: at 24 months post-surgery
measure: percentage of urinary incontinence
time frame: at 1 months post-surgery
measure: percentage of urinary incontinence
time frame: at 12 months post-surgery
measure: percentage of urinary incontinence
time frame: at 24 months post-surgery
arm group label: IfabondTM
arm group type: Experimental
description: Use of the synthetic glue IfabondTM
arm group label: sutures
arm group type: Active Comparator
description: Glue-Free Suture Technique
intervention type: Device
intervention name: Synthetic glue IfabondTM
description: Use of the synthetic glue IfabondTM
arm group label: IfabondTM
intervention type: Procedure
intervention name: Glue-Free Suture Technique
description: Suture Technique
arm group label: sutures
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Géry LAMBLIN, MD
role: Principal Investigator
affiliation: Gynaecology Department, Hôpital Femme Mère Enfant, HCL
facility: 
country: France
responsible party type: Sponsor
mesh term: Prolapse
sharing ipd: Undecided