<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/NCT04462835</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-FES-2019-96</org_study_id>
    <nct_id>NCT04462835</nct_id>
  </id_info>
  <brief_title>Feasibility, Effectiveness and Safety of Outpatient Hysteroscopy</brief_title>
  <acronym>FESHA</acronym>
  <official_title>Feasibility, Effectiveness and Safety of 3000 Hysteroscopies in Outpatient Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study Objective: The main objective of the study is to assess the feasibility, effectiveness&#xD;
      and safety of outpatient hysteroscopies performed in our Office Hysteroscopy Unit.&#xD;
&#xD;
      Design: Retrospective observational study of prospectively collected data from the Office&#xD;
      Hysteroscopy Unit database.&#xD;
&#xD;
      Setting: Tertiary care university hospital&#xD;
&#xD;
      Patients: Three thousand patients who consecutively attended an ambulatory hysteroscopy in&#xD;
      our centre from may 2008 to october 2019&#xD;
&#xD;
      Interventions: The Office hysteroscopy was performed with several rigid 5-6 mm diameter&#xD;
      devices when indicated with a diagnostic and/or therapeutic purpose&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retrospective observational study of our prospectively collected database of 3000 consecutive&#xD;
      hysteroscopies performed from may 2008 to october 2019 in our Office Hysteroscopy Unit (OHU).&#xD;
&#xD;
      All the patients who attended an ambulatory hysteroscopy in our centre during the study&#xD;
      period were included. There were not any exclusion criteria and all data were prospectively&#xD;
      collected in a computer database.&#xD;
&#xD;
      The primary endpoint was to determine the main results of the Outpatient Hysteroscopy Unit in&#xD;
      terms of feasibility, effectiveness and safety. Feasibility was defined as the proportion of&#xD;
      explorations that could be satisfactorily performed. Effectiveness was evaluated through the&#xD;
      percentage of cases that were solved in our outpatient setting and did not require the&#xD;
      operating room to complete their diagnosis or treatment. Safety was assessed as the&#xD;
      percentage of complications registered.&#xD;
&#xD;
      In addition, we registered the intensity of the pain perceived by the patient with a Verbal&#xD;
      Numerical Rating Scale (VNRS) (from 0 to 10) during the procedure and ten minutes later.&#xD;
&#xD;
      All the hysteroscopies were performed in our Office Hysteroscopy Unit by three experienced&#xD;
      gynaecologists who performed the hysteroscopy assisted by a nurse.&#xD;
&#xD;
      For pain and anxiety management, a painkiller (ibuprofen 600 mg) and an anxiolytic (diazepam&#xD;
      5 mg) were orally dispensed to all patients 30 minutes before the procedure. Cervical&#xD;
      preparation with Misoprostol (400 mcg, intravaginal administration 4-6 hours before the test)&#xD;
      was administered only in cases of anticipated or previous failed cervical passage.&#xD;
      Paracervical anaesthesia was administered in selected cases of several pain during the&#xD;
      passage through the cervical canal. Premenopausal women were asked to take desogestrel 75 mg,&#xD;
      at least 30 days prior to the procedure for endometrial preparation and if the patient was&#xD;
      unwilling to take the medication, the procedure was preferably performed in the early&#xD;
      follicular phase.&#xD;
&#xD;
      Hysteroscopy was performed with the several diagnostic and therapeutic rigid devices&#xD;
      available in our Office Hysteroscopy Unit in 5-6 mm diameter: mechanical instruments&#xD;
      (scissors and forceps), bipolar electrode (Versapoint ®), bipolar Gubini resector (Colibrí®)&#xD;
      and mechanical morcelators (Myosure® and Truclear®), They have been set up gradually in our&#xD;
      Unit. Saline solution 0.9% was used as a distention media with an automated pressure delivery&#xD;
      system and he vaginoscopic approach was performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility: proportion of hysteroscopies that could be satisfactorily performed</measure>
    <time_frame>3 months</time_frame>
    <description>Feasibility refers to the proportion of hysteroscopies that could be satisfactorily performed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efectiveness: Percentage of cases that were solved in our outpatient setting and did not require the operating room to complete their diagnosis or treatment</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of cases that were solved in our outpatient setting and did not require the operating room to complete their diagnosis or treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Percentage of complications registered</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of complications registered.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain during the hysteroscopy and 10 minutes later: Verbal Numerical Rating Scale (VNRS)</measure>
    <time_frame>3 months</time_frame>
    <description>The intensity of the pain perceived by the patient with a Verbal Numerical Rating Scale (VNRS) (from 0 which is no pain to 10 which is the worst pain ever imagined) during the procedure and ten minutes later.</description>
  </secondary_outcome>
  <enrollment type="Actual">3000</enrollment>
  <condition>Hysteroscopy</condition>
  <condition>Outpatient</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Women who attended an ambulatory hysteroscopy in our centre.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All the patients who attended an ambulatory hysteroscopy in our centre.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There were not any exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marta Simo Gonzalez</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Bakour SH, Jones SE, O'Donovan P. Ambulatory hysteroscopy: evidence-based guide to diagnosis and therapy. Best Pract Res Clin Obstet Gynaecol. 2006 Dec;20(6):953-75. doi: 10.1016/j.bpobgyn.2006.06.004. Epub 2006 Nov 20.</citation>
    <PMID>17116420</PMID>
  </reference>
  <reference>
    <citation>Capmas P, Pourcelot AG, Giral E, Fedida D, Fernandez H. Office hysteroscopy: A report of 2402 cases. J Gynecol Obstet Biol Reprod (Paris). 2016 May;45(5):445-50. doi: 10.1016/j.jgyn.2016.02.007. Epub 2016 Apr 4.</citation>
    <PMID>27055773</PMID>
  </reference>
  <reference>
    <citation>Bennett A, Lepage C, Thavorn K, Fergusson D, Murnaghan O, Coyle D, Singh SS. Effectiveness of Outpatient Versus Operating Room Hysteroscopy for the Diagnosis and Treatment of Uterine Conditions: A Systematic Review and Meta-Analysis. J Obstet Gynaecol Can. 2019 Jul;41(7):930-941. doi: 10.1016/j.jogc.2018.10.002. Epub 2018 Dec 7.</citation>
    <PMID>30528838</PMID>
  </reference>
  <reference>
    <citation>Krins T. Outpatient hysteroscopy. Aust N Z J Obstet Gynaecol. 2017 Oct;57(5):E10. doi: 10.1111/ajo.12662. No abstract available.</citation>
    <PMID>28967691</PMID>
  </reference>
  <reference>
    <citation>Diwakar L, Roberts TE, Cooper NA, Middleton L, Jowett S, Daniels J, Smith P, Clark TJ; OPT trial collaborative group. An economic evaluation of outpatient versus inpatient polyp treatment for abnormal uterine bleeding. BJOG. 2016 Mar;123(4):625-31. doi: 10.1111/1471-0528.13434. Epub 2015 May 25.</citation>
    <PMID>26011792</PMID>
  </reference>
  <reference>
    <citation>Campo R, Santangelo F, Gordts S, Di Cesare C, Van Kerrebroeck H, De Angelis MC, Di Spiezio Sardo A. Outpatient hysteroscopy. Facts Views Vis Obgyn. 2018 Sep;10(3):115-122.</citation>
    <PMID>31191845</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>August 17, 2020</last_update_submitted>
  <last_update_submitted_qc>August 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hysteroscopy</keyword>
  <keyword>outpatient</keyword>
  <keyword>Gold standard</keyword>
  <!-- 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/NCT04462835
org study id: IIBSP-FES-2019-96
nct id: NCT04462835
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Study Objective: The main objective of the study is to assess the feasibility, effectiveness
      and safety of outpatient hysteroscopies performed in our Office Hysteroscopy Unit.

      Design: Retrospective observational study of prospectively collected data from the Office
      Hysteroscopy Unit database.

      Setting: Tertiary care university hospital

      Patients: Three thousand patients who consecutively attended an ambulatory hysteroscopy in
      our centre from may 2008 to october 2019

      Interventions: The Office hysteroscopy was performed with several rigid 5-6 mm diameter
      devices when indicated with a diagnostic and/or therapeutic purpose
Retrospective observational study of our prospectively collected database of 3000 consecutive
      hysteroscopies performed from may 2008 to october 2019 in our Office Hysteroscopy Unit (OHU).

      All the patients who attended an ambulatory hysteroscopy in our centre during the study
      period were included. There were not any exclusion criteria and all data were prospectively
      collected in a computer database.

      The primary endpoint was to determine the main results of the Outpatient Hysteroscopy Unit in
      terms of feasibility, effectiveness and safety. Feasibility was defined as the proportion of
      explorations that could be satisfactorily performed. Effectiveness was evaluated through the
      percentage of cases that were solved in our outpatient setting and did not require the
      operating room to complete their diagnosis or treatment. Safety was assessed as the
      percentage of complications registered.

      In addition, we registered the intensity of the pain perceived by the patient with a Verbal
      Numerical Rating Scale (VNRS) (from 0 to 10) during the procedure and ten minutes later.

      All the hysteroscopies were performed in our Office Hysteroscopy Unit by three experienced
      gynaecologists who performed the hysteroscopy assisted by a nurse.

      For pain and anxiety management, a painkiller (ibuprofen 600 mg) and an anxiolytic (diazepam
      5 mg) were orally dispensed to all patients 30 minutes before the procedure. Cervical
      preparation with Misoprostol (400 mcg, intravaginal administration 4-6 hours before the test)
      was administered only in cases of anticipated or previous failed cervical passage.
      Paracervical anaesthesia was administered in selected cases of several pain during the
      passage through the cervical canal. Premenopausal women were asked to take desogestrel 75 mg,
      at least 30 days prior to the procedure for endometrial preparation and if the patient was
      unwilling to take the medication, the procedure was preferably performed in the early
      follicular phase.

      Hysteroscopy was performed with the several diagnostic and therapeutic rigid devices
      available in our Office Hysteroscopy Unit in 5-6 mm diameter: mechanical instruments
      (scissors and forceps), bipolar electrode (Versapoint ®), bipolar Gubini resector (Colibrí®)
      and mechanical morcelators (Myosure® and Truclear®), They have been set up gradually in our
      Unit. Saline solution 0.9% was used as a distention media with an automated pressure delivery
      system and he vaginoscopic approach was performed.
observational model: Case-Only
time perspective: Retrospective
measure: Feasibility: proportion of hysteroscopies that could be satisfactorily performed
time frame: 3 months
description: Feasibility refers to the proportion of hysteroscopies that could be satisfactorily performed
measure: Efectiveness: Percentage of cases that were solved in our outpatient setting and did not require the operating room to complete their diagnosis or treatment
time frame: 3 months
description: Percentage of cases that were solved in our outpatient setting and did not require the operating room to complete their diagnosis or treatment
measure: Safety: Percentage of complications registered
time frame: 3 months
description: Percentage of complications registered.
measure: Pain during the hysteroscopy and 10 minutes later: Verbal Numerical Rating Scale (VNRS)
time frame: 3 months
description: The intensity of the pain perceived by the patient with a Verbal Numerical Rating Scale (VNRS) (from 0 which is no pain to 10 which is the worst pain ever imagined) during the procedure and ten minutes later.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Marta Simo Gonzalez
role: Principal Investigator
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
facility: 
country: Spain
citation: Bakour SH, Jones SE, O'Donovan P. Ambulatory hysteroscopy: evidence-based guide to diagnosis and therapy. Best Pract Res Clin Obstet Gynaecol. 2006 Dec;20(6):953-75. doi: 10.1016/j.bpobgyn.2006.06.004. Epub 2006 Nov 20.
PMID: 17116420
citation: Capmas P, Pourcelot AG, Giral E, Fedida D, Fernandez H. Office hysteroscopy: A report of 2402 cases. J Gynecol Obstet Biol Reprod (Paris). 2016 May;45(5):445-50. doi: 10.1016/j.jgyn.2016.02.007. Epub 2016 Apr 4.
PMID: 27055773
citation: Bennett A, Lepage C, Thavorn K, Fergusson D, Murnaghan O, Coyle D, Singh SS. Effectiveness of Outpatient Versus Operating Room Hysteroscopy for the Diagnosis and Treatment of Uterine Conditions: A Systematic Review and Meta-Analysis. J Obstet Gynaecol Can. 2019 Jul;41(7):930-941. doi: 10.1016/j.jogc.2018.10.002. Epub 2018 Dec 7.
PMID: 30528838
citation: Krins T. Outpatient hysteroscopy. Aust N Z J Obstet Gynaecol. 2017 Oct;57(5):E10. doi: 10.1111/ajo.12662. No abstract available.
PMID: 28967691
citation: Diwakar L, Roberts TE, Cooper NA, Middleton L, Jowett S, Daniels J, Smith P, Clark TJ; OPT trial collaborative group. An economic evaluation of outpatient versus inpatient polyp treatment for abnormal uterine bleeding. BJOG. 2016 Mar;123(4):625-31. doi: 10.1111/1471-0528.13434. Epub 2015 May 25.
PMID: 26011792
citation: Campo R, Santangelo F, Gordts S, Di Cesare C, Van Kerrebroeck H, De Angelis MC, Di Spiezio Sardo A. Outpatient hysteroscopy. Facts Views Vis Obgyn. 2018 Sep;10(3):115-122.
PMID: 31191845
responsible party type: Sponsor