<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/NCT03766048</url>
  </required_header>
  <id_info>
    <org_study_id>2017_74</org_study_id>
    <secondary_id>2018-A01487-48</secondary_id>
    <secondary_id>PHRCN-17-0226</secondary_id>
    <nct_id>NCT03766048</nct_id>
  </id_info>
  <brief_title>LAparoscopic Preventive PRErectal Mesh</brief_title>
  <acronym>LAPREM</acronym>
  <official_title>Non-inferiority Randomized Double Blind Controlled Trial Comparing Results of Laparoscopic Sacrocolpopexy With or Without Preventive Prerectal Mesh in Women Operated for Urogenital Prolapse Without Significant Posterior Vaginal Wall Prolapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</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>
      Urogenital prolapse is a frequent and invalidating pathology in women, involving the anterior&#xD;
      vaginal wall and the uterus in most cases. Posterior vaginal wall prolapse is present in only&#xD;
      50% of cases. Surgery is an option for women with troublesome prolapse. A woman's lifetime&#xD;
      risk of undergoing surgery for pelvic organ prolapse (POP) surgery by the age of 80 is around&#xD;
      19%. Laparoscopic sacrocolpopexy (LS) with synthetic non-absorbable mesh is considered the&#xD;
      gold standard, with a composite success rate of 85% at one year (Prospere study). Based on&#xD;
      early experience and historical habits, a prerectal mesh was used to be systematically placed&#xD;
      in the rectovaginal space, in addition to the anterior and apical mesh placed in the&#xD;
      vesicovaginal space, in order to prevent de-novo posterior prolapse (reported rates up to&#xD;
      33%).&#xD;
&#xD;
      The benefit of preventive prerectal mesh is questionned on the basis of a single&#xD;
      retrospective study comparing 68 LS with double-mesh (anterior &amp; posterior, DM) to 32 LS with&#xD;
      a single anterior mesh (SAM): posterior recurrence rates were respectively 5.9 vs. 31.3%&#xD;
      (p&lt;0,01), and total recurrence rates 16.2 vs. 43.8% (p&lt;0.01). However, as this difference was&#xD;
      not significant in the subgroup of patients without associated cervicocystopexy, the authors&#xD;
      concluded that the risk of posterior failure was only due to the cervicocystopexy itself&#xD;
      (anti-urinary incontinence procedure which has been abandoned since).&#xD;
&#xD;
      On the other hand, a prerectal mesh increases the risk for specific complications: rectal&#xD;
      injury (up to 3%), anal pain (up to 25%), mesh exposition (up to 2%). Furthermore the&#xD;
      posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study,&#xD;
      unpublished data). The rate of de-novo obstructed defecation after LS with prerectal mesh is&#xD;
      reported up to 25%. It could be explained by the mesh itself, but also by nerve injuries&#xD;
      during the dissection of the rectovaginal space and rectal stalks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 11, 2019</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite criteria of success at 2 years follow-up</measure>
    <time_frame>at 2 years after the intervention</time_frame>
    <description>Composite criteria of success at 2 years follow-up: no symptom of vaginal bulge, no prolapse beyond the hymen (&gt;0 cm), no reintervention for prolapse recurrence. Its advantage is that it considers only recurrences that are symptomatic or needing a reintervention. It is strongly linked with women satisfaction after prolapse surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anatomical results</measure>
    <time_frame>at 2 years</time_frame>
    <description>Anatomical results will be based on clinical evaluation of patients at 2 years follow-up using the POP-Q system, with a specific evaluation of posterior vaginal wall with measures of the Bp point</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">834</enrollment>
  <condition>Urogenital Prolapse</condition>
  <arm_group>
    <arm_group_label>Single-Anterior-Mesh, SAM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Double-Mesh, DM</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Single-Anterior-Mesh, SAM</intervention_name>
    <description>laparoscopic sacropexy is only performed with the anterior mes</description>
    <arm_group_label>Single-Anterior-Mesh, SAM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Double-Mesh, DM</intervention_name>
    <description>laparoscopic sacropexy is performed using two synthetic non-absorbable meshes, both sutured to the promontory (Double-Mesh, DM): one mesh is placed in the vesicovaginal space and sutured to the uterine cervix or vaginal apex, and one mesh is placed in the rectovaginal space</description>
    <arm_group_label>Double-Mesh, DM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with a urogenital prolapse (anterior wall and/or uterus or vaginal apex) stage =&#xD;
             2 (Ba and/or C points ≥ - 1 cm using the POP-Q system),&#xD;
&#xD;
          -  without significant posterior vaginal wall prolapse (Bp &lt; -1 cm when apical prolapse&#xD;
             is reduced using a retractor leaving the posterior vaginal wall free),&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous surgical repair for Pelvic Organ Prolapse&#xD;
&#xD;
          -  Any associated prolapse requiring any non-authorized additional surgical repair&#xD;
             (Authorized additional surgical procedures are hysterectomy, ovariectomy, adnexectomy,&#xD;
             salpingectomy, myomectomy, or suburethral vaginal tape.)&#xD;
&#xD;
          -  Wish for future pregnancy&#xD;
&#xD;
          -  Lack of health insurance&#xD;
&#xD;
          -  Woman not reading French or unable to consent&#xD;
&#xD;
          -  Woman under law protection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women with a urogenital prolapse for whom a laparoscopic sacrocolpopexy is planned.</gender_description>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Philippe LUCOT, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jean-Philippe LUCOT, MD,PhD</last_name>
    <phone>(0)3 21 45 62</phone>
    <phone_ext>+33</phone_ext>
    <email>lucot.jean-philippe@ghicl.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hopital Estaing</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ch Dunkerque</name>
      <address>
        <city>Dunkerque</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Saint-Louis - La Rochelle</name>
      <address>
        <city>La Rochelle</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinique Du Pre</name>
      <address>
        <city>Le Mans</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hop Jeanne de Flandre Chu Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>0320445962</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Vincent - Saint Antoine</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>0320445962</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu de Nice Hopital de L'Archet</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chu Nimes - Nimes</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chi Poissy St Germain Site de Poissy</name>
      <address>
        <city>Poissy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>February 3, 2023</last_update_submitted>
  <last_update_submitted_qc>February 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urogenital prolapse</keyword>
  <keyword>laparoscopic sacropexy</keyword>
  <keyword>mesh</keyword>
  <keyword>medico-economic study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <!-- 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/NCT03766048
org study id: 2017_74
secondary id: 2018-A01487-48
secondary id: PHRCN-17-0226
nct id: NCT03766048
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Urogenital prolapse is a frequent and invalidating pathology in women, involving the anterior
      vaginal wall and the uterus in most cases. Posterior vaginal wall prolapse is present in only
      50% of cases. Surgery is an option for women with troublesome prolapse. A woman's lifetime
      risk of undergoing surgery for pelvic organ prolapse (POP) surgery by the age of 80 is around
      19%. Laparoscopic sacrocolpopexy (LS) with synthetic non-absorbable mesh is considered the
      gold standard, with a composite success rate of 85% at one year (Prospere study). Based on
      early experience and historical habits, a prerectal mesh was used to be systematically placed
      in the rectovaginal space, in addition to the anterior and apical mesh placed in the
      vesicovaginal space, in order to prevent de-novo posterior prolapse (reported rates up to
      33%).

      The benefit of preventive prerectal mesh is questionned on the basis of a single
      retrospective study comparing 68 LS with double-mesh (anterior & posterior, DM) to 32 LS with
      a single anterior mesh (SAM): posterior recurrence rates were respectively 5.9 vs. 31.3%
      (p<0,01), and total recurrence rates 16.2 vs. 43.8% (p<0.01). However, as this difference was
      not significant in the subgroup of patients without associated cervicocystopexy, the authors
      concluded that the risk of posterior failure was only due to the cervicocystopexy itself
      (anti-urinary incontinence procedure which has been abandoned since).

      On the other hand, a prerectal mesh increases the risk for specific complications: rectal
      injury (up to 3%), anal pain (up to 25%), mesh exposition (up to 2%). Furthermore the
      posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study,
      unpublished data). The rate of de-novo obstructed defecation after LS with prerectal mesh is
      reported up to 25%. It could be explained by the mesh itself, but also by nerve injuries
      during the dissection of the rectovaginal space and rectal stalks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Composite criteria of success at 2 years follow-up
time frame: at 2 years after the intervention
description: Composite criteria of success at 2 years follow-up: no symptom of vaginal bulge, no prolapse beyond the hymen (>0 cm), no reintervention for prolapse recurrence. Its advantage is that it considers only recurrences that are symptomatic or needing a reintervention. It is strongly linked with women satisfaction after prolapse surgery.
measure: Anatomical results
time frame: at 2 years
description: Anatomical results will be based on clinical evaluation of patients at 2 years follow-up using the POP-Q system, with a specific evaluation of posterior vaginal wall with measures of the Bp point
arm group label: Single-Anterior-Mesh, SAM
arm group type: Experimental
arm group label: Double-Mesh, DM
arm group type: Sham Comparator
intervention type: Procedure
intervention name: Single-Anterior-Mesh, SAM
description: laparoscopic sacropexy is only performed with the anterior mes
arm group label: Single-Anterior-Mesh, SAM
intervention type: Procedure
intervention name: Double-Mesh, DM
description: laparoscopic sacropexy is performed using two synthetic non-absorbable meshes, both sutured to the promontory (Double-Mesh, DM): one mesh is placed in the vesicovaginal space and sutured to the uterine cervix or vaginal apex, and one mesh is placed in the rectovaginal space
arm group label: Double-Mesh, DM
criteria: 
gender: Female
gender based: Yes
gender description: Women with a urogenital prolapse for whom a laparoscopic sacrocolpopexy is planned.
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jean-Philippe LUCOT, MD,PhD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Jean-Philippe LUCOT, MD,PhD
phone: (0)3 21 45 62
phone ext: +33
email: lucot.jean-philippe@ghicl.net
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse