<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/NCT03764852</url>
  </required_header>
  <id_info>
    <org_study_id>18-PP-12</org_study_id>
    <nct_id>NCT03764852</nct_id>
  </id_info>
  <brief_title>AMBULAPSE STUDY Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy With or Without Robotic Assistance, in Female Patients Presenting With Symptomatic Pelvic Organ Prolapse, Based on an Outpatient Treatment Model.</brief_title>
  <acronym>AMBULAPSE</acronym>
  <official_title>Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy With or Without Robotic Assistance, in Female Patients Presenting With Symptomatic Pelvic Organ Prolapse, Based on an Outpatient Treatment Model.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</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>
      Pelvic organ prolapse is an increasingly common functional disorder which affects&#xD;
      approximately 30 to 40% of the female population, 12% of whom have a symptomatic form, with a&#xD;
      psychological, physical and social impact. Laparoscopic sacrocolpopexy represents the&#xD;
      surgical &quot;gold standard&quot; for the treatment of this functional disorder. It aims to suspend&#xD;
      the vaginal vault by means of a prosthesis. The patient satisfaction rate is evaluated at 94%&#xD;
      with low overall complication rate, evaluated at 11%.&#xD;
&#xD;
      Pelvic organ prolapse surgery is a common, with an estimated 30,000 procedures carried out in&#xD;
      France in 2013 (excluding hysterectomy) (2013 ATIH data), and the number will increase in the&#xD;
      future due to increasing life expectancy. 13% of women will undergo this type of procedure.&#xD;
      The French General Directorate of Health Care Supply (DGOS) deems outpatient surgery to be&#xD;
      the benchmark for surgical activity in all eligible patients, and has expressed the need for&#xD;
      recommendations and tools for supporting its development. The rate of outpatient surgery for&#xD;
      prolapse remains low in France (6.1%, 2015 ATIH data), while it is 25% in the US and 56% in&#xD;
      Denmark. The average duration of hospital stays for DRG N81.2 (first degree uterine prolapse)&#xD;
      in 2015 was 3.43 days. These procedures have been the subject of publications concerning&#xD;
      outpatient care and involving low numbers of patients, with the exception of the publication&#xD;
      by Sinhal which involved 111 patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In our study, the investigators propose to evaluate the success rate for outpatient&#xD;
      laparoscopic sacrocolpopexy with or without robotic assistance in screened patients. With&#xD;
      this aim in mind, the investigators will conduct a national multicenter prospective study&#xD;
      including 80 female patients. Successful outpatient treatment is defined by the absence of&#xD;
      conventional inpatient admission with 24H after surgery, the indications for admission being&#xD;
      a CHUNG Score &lt; 9, one perioperative complication, postoperative urinary retention requiring&#xD;
      reinsertion of a urinary catheter. The outpatient success rate for other surgical techniques&#xD;
      such as cholecystectomy or laparoscopic hysterectomy is above 90% in the literature.&#xD;
      Envisaging an equivalent rate after laparoscopic sacrocolpopexy, our population size would&#xD;
      make it possible to obtain precision +/- 5.3% for estimation of this proportion. The patients&#xD;
      are followed up for 1 month with a postoperative visit at 30 days, during which the efficacy&#xD;
      of the technique is evaluated using conventional indicators (POP-Q; ICIQ, USP, PFDI-20,&#xD;
      PISQ-12, PFIQ-7, etc.). Once completed, this preliminary investigation will make it possible&#xD;
      to define a reference value for successful outpatient sacrocolpopexy, which has not yet been&#xD;
      published, which may be used as a basis for a larger scale randomized study that would aim to&#xD;
      compare the efficacy of outpatient treatment, with conventional inpatient treatment, for&#xD;
      efficient patient management&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 14, 2019</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful outpatient treatment</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Successful outpatient treatment is defined by the absence of conventional inpatient admission with 24H after surgery, the indications for admission being a CHUNG Score &lt; 9, one perioperative complication, postoperative urinary retention requiring reinsertion of a urinary catheter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of failure of the outpatient</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>The percentage of failure of the outpatient is defined by the number of patients with a CHUNG score &lt;9 in the outpatient department that does not allow the discharge of the patient or her admission to conventional hospitalization.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>outpatient laparoscopic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will have laparoscopic outpatients. The procedure is identical to that performed in hospital. What changes is that the patient will return home at night if her condition allows it.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>outpatient laparoscopic</intervention_name>
    <description>The intervention is a outpatient laparoscopic sacrocolpopexy with robotic assistance.</description>
    <arm_group_label>outpatient laparoscopic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>outpatient laparoscopic</intervention_name>
    <description>The intervention is a outpatient laparoscopic sacrocolpopexy without robotic assistance.</description>
    <arm_group_label>outpatient laparoscopic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  woman between 40 and 80 years old&#xD;
&#xD;
          -  Patient with significant prolapse POP-Q ≥ 2&#xD;
&#xD;
          -  BMI &lt;30&#xD;
&#xD;
          -  ASA score ≤ 2&#xD;
&#xD;
          -  sterile ECBU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Criteria related to the pathology or the organ:&#xD;
&#xD;
               -  History of pelvic cancer surgery&#xD;
&#xD;
               -  History of prolapse surgery&#xD;
&#xD;
               -  History of pelvic irradiation&#xD;
&#xD;
               -  Laying a concomitant urethral strip&#xD;
&#xD;
               -  Cervico-vaginal smear test not up to date.&#xD;
&#xD;
               -  Patient pregnant or having a desire for pregnancy&#xD;
&#xD;
          -  Criteria related to concomitant treatments:&#xD;
&#xD;
               -  Cefazoline allergy&#xD;
&#xD;
               -  Taking the following medications within 48 hours&#xD;
&#xD;
          -  Plavix®&#xD;
&#xD;
          -  Vitamin K / Low Molecular Weight Healing Heparin&#xD;
&#xD;
               -  Contraindication to ambulatory care for medical reasons&#xD;
&#xD;
          -  Sleep apnea syndrome&#xD;
&#xD;
          -  Cardiopulmonary pathology&#xD;
&#xD;
          -  Psychiatric pathology&#xD;
&#xD;
          -  Hemorrhagic risk&#xD;
&#xD;
          -  Diabetes imbalanced&#xD;
&#xD;
          -  Unbalanced Hypertension&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only woman with pelvic organ prolapse</gender_description>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brannwel TIBI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nice</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brannwel TIBI, MD</last_name>
    <phone>0492037849</phone>
    <email>tibi.b@chu-nice.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthieu DURAND, MD</last_name>
    <phone>0492037849</phone>
    <email>durand.m@chu-nice.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hopital Antoine Beclere - Aphp</name>
      <address>
        <city>Clamart</city>
        <zip>92140</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier DEFFIEUX, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie-Aimée PERROUIN-VERBE, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU DE Nice - Hôpital l'Archet</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maxence DOREZ, MD</last_name>
      <email>dorez.m@chu-nice.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ch Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alain RUFFION, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adrien VIDART, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Drapier E, De Poncheville L, Dannappel T, Clerc P, Smirnoff A. [Day case laparoscopic sacral colpopexy for genital prolapse]. Prog Urol. 2014 Jan;24(1):51-6. doi: 10.1016/j.purol.2013.07.007. Epub 2013 Aug 13. French.</citation>
    <PMID>24365629</PMID>
  </reference>
  <reference>
    <citation>Bump RC, Norton PA. Epidemiology and natural history of pelvic floor dysfunction. Obstet Gynecol Clin North Am. 1998 Dec;25(4):723-46. doi: 10.1016/s0889-8545(05)70039-5.</citation>
    <PMID>9921553</PMID>
  </reference>
  <results_reference>
    <citation>Flam F. Sedation and local anaesthesia for vaginal pelvic floor repair of genital prolapse using mesh. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Dec;18(12):1471-5. doi: 10.1007/s00192-007-0350-8. Epub 2007 Mar 17.</citation>
    <PMID>17370026</PMID>
  </results_reference>
  <results_reference>
    <citation>Cuvelier G. [The ambulatory surgery, source of publications]. Prog Urol. 2013 Jun;23(7):427-9. doi: 10.1016/j.purol.2013.02.007. Epub 2013 Mar 26. No abstract available. French.</citation>
    <PMID>23721700</PMID>
  </results_reference>
  <verification_date>February 2020</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 7, 2020</last_update_submitted>
  <last_update_submitted_qc>February 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>outpatient</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>
  <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/NCT03764852
org study id: 18-PP-12
nct id: NCT03764852
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pelvic organ prolapse is an increasingly common functional disorder which affects
      approximately 30 to 40% of the female population, 12% of whom have a symptomatic form, with a
      psychological, physical and social impact. Laparoscopic sacrocolpopexy represents the
      surgical "gold standard" for the treatment of this functional disorder. It aims to suspend
      the vaginal vault by means of a prosthesis. The patient satisfaction rate is evaluated at 94%
      with low overall complication rate, evaluated at 11%.

      Pelvic organ prolapse surgery is a common, with an estimated 30,000 procedures carried out in
      France in 2013 (excluding hysterectomy) (2013 ATIH data), and the number will increase in the
      future due to increasing life expectancy. 13% of women will undergo this type of procedure.
      The French General Directorate of Health Care Supply (DGOS) deems outpatient surgery to be
      the benchmark for surgical activity in all eligible patients, and has expressed the need for
      recommendations and tools for supporting its development. The rate of outpatient surgery for
      prolapse remains low in France (6.1%, 2015 ATIH data), while it is 25% in the US and 56% in
      Denmark. The average duration of hospital stays for DRG N81.2 (first degree uterine prolapse)
      in 2015 was 3.43 days. These procedures have been the subject of publications concerning
      outpatient care and involving low numbers of patients, with the exception of the publication
      by Sinhal which involved 111 patients.
In our study, the investigators propose to evaluate the success rate for outpatient
      laparoscopic sacrocolpopexy with or without robotic assistance in screened patients. With
      this aim in mind, the investigators will conduct a national multicenter prospective study
      including 80 female patients. Successful outpatient treatment is defined by the absence of
      conventional inpatient admission with 24H after surgery, the indications for admission being
      a CHUNG Score < 9, one perioperative complication, postoperative urinary retention requiring
      reinsertion of a urinary catheter. The outpatient success rate for other surgical techniques
      such as cholecystectomy or laparoscopic hysterectomy is above 90% in the literature.
      Envisaging an equivalent rate after laparoscopic sacrocolpopexy, our population size would
      make it possible to obtain precision +/- 5.3% for estimation of this proportion. The patients
      are followed up for 1 month with a postoperative visit at 30 days, during which the efficacy
      of the technique is evaluated using conventional indicators (POP-Q; ICIQ, USP, PFDI-20,
      PISQ-12, PFIQ-7, etc.). Once completed, this preliminary investigation will make it possible
      to define a reference value for successful outpatient sacrocolpopexy, which has not yet been
      published, which may be used as a basis for a larger scale randomized study that would aim to
      compare the efficacy of outpatient treatment, with conventional inpatient treatment, for
      efficient patient management
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful outpatient treatment
time frame: 24 hours after surgery
description: Successful outpatient treatment is defined by the absence of conventional inpatient admission with 24H after surgery, the indications for admission being a CHUNG Score < 9, one perioperative complication, postoperative urinary retention requiring reinsertion of a urinary catheter
measure: The percentage of failure of the outpatient
time frame: 24 hours after surgery
description: The percentage of failure of the outpatient is defined by the number of patients with a CHUNG score <9 in the outpatient department that does not allow the discharge of the patient or her admission to conventional hospitalization.
arm group label: outpatient laparoscopic
arm group type: Experimental
description: Patients will have laparoscopic outpatients. The procedure is identical to that performed in hospital. What changes is that the patient will return home at night if her condition allows it.
intervention type: Procedure
intervention name: outpatient laparoscopic
description: The intervention is a outpatient laparoscopic sacrocolpopexy with robotic assistance.
arm group label: outpatient laparoscopic
intervention type: Procedure
intervention name: outpatient laparoscopic
description: The intervention is a outpatient laparoscopic sacrocolpopexy without robotic assistance.
arm group label: outpatient laparoscopic
criteria: 
gender: Female
gender based: Yes
gender description: Only woman with pelvic organ prolapse
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Brannwel TIBI, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nice
last name: Brannwel TIBI, MD
phone: 0492037849
email: tibi.b@chu-nice.fr
last name: Matthieu DURAND, MD
phone: 0492037849
email: durand.m@chu-nice.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
citation: Drapier E, De Poncheville L, Dannappel T, Clerc P, Smirnoff A. [Day case laparoscopic sacral colpopexy for genital prolapse]. Prog Urol. 2014 Jan;24(1):51-6. doi: 10.1016/j.purol.2013.07.007. Epub 2013 Aug 13. French.
PMID: 24365629
citation: Bump RC, Norton PA. Epidemiology and natural history of pelvic floor dysfunction. Obstet Gynecol Clin North Am. 1998 Dec;25(4):723-46. doi: 10.1016/s0889-8545(05)70039-5.
PMID: 9921553
citation: Flam F. Sedation and local anaesthesia for vaginal pelvic floor repair of genital prolapse using mesh. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Dec;18(12):1471-5. doi: 10.1007/s00192-007-0350-8. Epub 2007 Mar 17.
PMID: 17370026
citation: Cuvelier G. [The ambulatory surgery, source of publications]. Prog Urol. 2013 Jun;23(7):427-9. doi: 10.1016/j.purol.2013.02.007. Epub 2013 Mar 26. No abstract available. French.
PMID: 23721700
responsible party type: Sponsor
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No