<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/NCT01710579</url>
  </required_header>
  <id_info>
    <org_study_id>2012.729</org_study_id>
    <nct_id>NCT01710579</nct_id>
  </id_info>
  <brief_title>Normal Values in Ano-rectal 3D High Resolution Manometry</brief_title>
  <acronym>NOMAD</acronym>
  <official_title>Ano-rectal 3D High Resolution Manometry: Normal Values and Comparison With Ultrasound Examination in Healthy Volunteers, Patients With Fecal Incontinence and Patients With Constipation</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ano-rectal manometry is indicative in patients with either fecal incontinence or&#xD;
      constipation. Recently anorectal 3D- high resolution manometry has been developed. Pressure&#xD;
      variations are measured circumferentially along the anal canal. It may allow a better&#xD;
      understanding of anorectal disorders by displaying anal pressure asymmetry and it could be&#xD;
      useful to assess the functional anatomy of the pelvic floor better than conventional&#xD;
      manometry.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anal pressure pattern at rest, during voluntary maximal squeezing and bear down Anal pressure pattern at rest, during voluntary maximal squeezing and bear down</measure>
    <time_frame>during procedure</time_frame>
    <description>Following parameters will be measured at the level of anal sphincter:&#xD;
Minimal pressure (amplitude and location)&#xD;
Maximal pressure (amplitude and location)&#xD;
Mean pressure&#xD;
Asymmetry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>presence of ano-rectal reflex.</measure>
    <time_frame>during procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ano-rectal radial endosonography</measure>
    <time_frame>During procedure</time_frame>
    <description>Evaluation of internal and external anal sphincter integrity and puborectalis muscle at rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic ano-rectal endoconography</measure>
    <time_frame>During procedure</time_frame>
    <description>presence of pelvic floor disorder (rectocele, enterocele)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Anorectal Disorder</condition>
  <condition>Fecal Incontinence</condition>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>ARM 1 Healthy Volunteers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARM 2: Patients with fecal incontinence</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARM 3 Patients with constipation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anorectal 3D-high resolution manometry</intervention_name>
    <description>Anorectal probe is used with a single-use protective sheath with an inflation balloon Control of balloon deflation Patient in left lateral decubitus position with hips flexed to 90° (this position is the most commonly use and the most convenient) Transanal insertion 2 minutes resting period: resting anal pressure will be evaluated the second minute of rest Sustained voluntary maximal squeeze for at least 30 seconds; the maneuver will be repeated once Valsalva Bear down maneuver; the maneuver will be repeated once Anorectal reflexes evaluation with 20-, 40- and 60-ml intra-rectal balloon inflation Probe removal</description>
    <arm_group_label>ARM 1 Healthy Volunteers</arm_group_label>
    <arm_group_label>ARM 2: Patients with fecal incontinence</arm_group_label>
    <arm_group_label>ARM 3 Patients with constipation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anorectal radial endosonography (rotative 360° probe)</intervention_name>
    <description>Patient in left lateral decubitus position with hips flexed to 90° Transanal probe insertion Evaluation of internal and external anal sphincter integrity and puborectalis muscle at rest</description>
    <arm_group_label>ARM 1 Healthy Volunteers</arm_group_label>
    <arm_group_label>ARM 2: Patients with fecal incontinence</arm_group_label>
    <arm_group_label>ARM 3 Patients with constipation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dynamic anorectal endosonography (sagittal and radial)</intervention_name>
    <description>Patient in left lateral decubitus position with hips flexed to 90° Rectum is filled with 50-ml water Probe is covered with a water-filled balloon to maintain the acoustic window for the ultrasound wave Transanal probe insertion Slow and manual rotation of the linear probe through 360° to identify the various layers constituting the anal wall (mucosa, IAS, EAS), the layer forming the rectal wall and the perirectal tissues (puborectalis muscle, bladder, and vagina or prostate) After the initial examination, the patient will be asked to make a defecation effort with the probe left in the same position</description>
    <arm_group_label>ARM 1 Healthy Volunteers</arm_group_label>
    <arm_group_label>ARM 2: Patients with fecal incontinence</arm_group_label>
    <arm_group_label>ARM 3 Patients with constipation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Arm 1: 50 healthy volunteers Inclusions will be stratified on gender (10 males, 40&#xD;
        females), age (15 subjects under 40 years; 20 subjects between 40 and 60 years; and 15&#xD;
        subjects &gt;60 years) and parous (10 nullipara and 30 parous women).&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        Subject older than 18 years Absence of anorectal symptoms (no constipation, no fecal&#xD;
        incontinence) Absence of pelvic floor disorders Vaizey score = 0 Kess score &lt; 9 Subject&#xD;
        with health insurance Written informed consent Non inclusion criteria: Patient younger than&#xD;
        18 years Pregnancy Incapability to give consent No written informed consent Participation&#xD;
        to another study at the same time Previous ano-rectal surgery Pelvic radiotherapy&#xD;
        Neurological disorder Diabetes mellitus&#xD;
&#xD;
        Arm 2: 50 patients with fecal incontinence&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        Subject older than 18 years Patient referred for anorectal manometry and/or ultrasound&#xD;
        examination Fecal incontinence as main complain Vaizey score &gt; 6 Kess score &lt; 9 Subject&#xD;
        with health insurance Written informed consent&#xD;
&#xD;
        Non inclusion criteria:&#xD;
&#xD;
        Patient younger than 18 years Pregnancy Incapability to give consent No written informed&#xD;
        consent Participation to another study at the same time Rectal tumor Rectal stenosis&#xD;
        Ileo-anal or ileo-rectal anastomosis Anal fissure Anal fistula Arm 3: 50 patients with&#xD;
        constipation&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        Subject older than 18 years Patient referred for anorectal manometry and/or ultrasound&#xD;
        examination Constipation as main complain Feeling of incomplete evacuation and/or manual&#xD;
        disimpaction defined as needing to press in or around the anus to aid defecation Vaizey&#xD;
        score &lt; 6 Kess score &lt; 9 Subject with health insurance Written informed consent&#xD;
&#xD;
        Non inclusion criteria:&#xD;
&#xD;
        Patient younger than 18 years Pregnancy Incapability to give consent No written informed&#xD;
        consent Participation to another study at the same time Rectal tumor Rectal stenosis&#xD;
        Ileo-anal or ileo-rectal anastomosis Anal fissure Anal fistula&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Unité d'Exploration Fonctionnelle Digestive Hôpital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Mion F, Garros A, Brochard C, Vitton V, Ropert A, Bouvier M, Damon H, Siproudhis L, Roman S. 3D High-definition anorectal manometry: Values obtained in asymptomatic volunteers, fecal incontinence and chronic constipation. Results of a prospective multicenter study (NOMAD). Neurogastroenterol Motil. 2017 Aug;29(8). doi: 10.1111/nmo.13049. Epub 2017 Mar 2.</citation>
    <PMID>28251732</PMID>
  </results_reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>May 23, 2019</last_update_submitted>
  <last_update_submitted_qc>May 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Primary esophageal achalasia</keyword>
  <keyword>endoscopic myotomy</keyword>
  <keyword>high resolution manometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
    <mesh_term>Rectal Diseases</mesh_term>
    <mesh_term>Constipation</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/NCT01710579
org study id: 2012.729
nct id: NCT01710579
lead sponsor: 
has dmc: Yes
Ano-rectal manometry is indicative in patients with either fecal incontinence or
      constipation. Recently anorectal 3D- high resolution manometry has been developed. Pressure
      variations are measured circumferentially along the anal canal. It may allow a better
      understanding of anorectal disorders by displaying anal pressure asymmetry and it could be
      useful to assess the functional anatomy of the pelvic floor better than conventional
      manometry.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Anal pressure pattern at rest, during voluntary maximal squeezing and bear down Anal pressure pattern at rest, during voluntary maximal squeezing and bear down
time frame: during procedure
description: Following parameters will be measured at the level of anal sphincter:
Minimal pressure (amplitude and location)
Maximal pressure (amplitude and location)
Mean pressure
Asymmetry
measure: presence of ano-rectal reflex.
time frame: during procedure
measure: Ano-rectal radial endosonography
time frame: During procedure
description: Evaluation of internal and external anal sphincter integrity and puborectalis muscle at rest
measure: Dynamic ano-rectal endoconography
time frame: During procedure
description: presence of pelvic floor disorder (rectocele, enterocele)
arm group label: ARM 1 Healthy Volunteers
arm group type: Other
description: Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
arm group label: ARM 2: Patients with fecal incontinence
arm group type: Other
description: Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
arm group label: ARM 3 Patients with constipation
arm group type: Other
description: Ano-rectal 3D high resolution manometry, ano-rectal radial endsonography, dynamic ano-rectal endosonography
intervention type: Procedure
intervention name: Anorectal 3D-high resolution manometry
description: Anorectal probe is used with a single-use protective sheath with an inflation balloon Control of balloon deflation Patient in left lateral decubitus position with hips flexed to 90° (this position is the most commonly use and the most convenient) Transanal insertion 2 minutes resting period: resting anal pressure will be evaluated the second minute of rest Sustained voluntary maximal squeeze for at least 30 seconds; the maneuver will be repeated once Valsalva Bear down maneuver; the maneuver will be repeated once Anorectal reflexes evaluation with 20-, 40- and 60-ml intra-rectal balloon inflation Probe removal
arm group label: ARM 1 Healthy Volunteers
arm group label: ARM 2: Patients with fecal incontinence
arm group label: ARM 3 Patients with constipation
intervention type: Procedure
intervention name: Anorectal radial endosonography (rotative 360° probe)
description: Patient in left lateral decubitus position with hips flexed to 90° Transanal probe insertion Evaluation of internal and external anal sphincter integrity and puborectalis muscle at rest
arm group label: ARM 1 Healthy Volunteers
arm group label: ARM 2: Patients with fecal incontinence
arm group label: ARM 3 Patients with constipation
intervention type: Procedure
intervention name: Dynamic anorectal endosonography (sagittal and radial)
description: Patient in left lateral decubitus position with hips flexed to 90° Rectum is filled with 50-ml water Probe is covered with a water-filled balloon to maintain the acoustic window for the ultrasound wave Transanal probe insertion Slow and manual rotation of the linear probe through 360° to identify the various layers constituting the anal wall (mucosa, IAS, EAS), the layer forming the rectal wall and the perirectal tissues (puborectalis muscle, bladder, and vagina or prostate) After the initial examination, the patient will be asked to make a defecation effort with the probe left in the same position
arm group label: ARM 1 Healthy Volunteers
arm group label: ARM 2: Patients with fecal incontinence
arm group label: ARM 3 Patients with constipation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
citation: Mion F, Garros A, Brochard C, Vitton V, Ropert A, Bouvier M, Damon H, Siproudhis L, Roman S. 3D High-definition anorectal manometry: Values obtained in asymptomatic volunteers, fecal incontinence and chronic constipation. Results of a prospective multicenter study (NOMAD). Neurogastroenterol Motil. 2017 Aug;29(8). doi: 10.1111/nmo.13049. Epub 2017 Mar 2.
PMID: 28251732
responsible party type: Sponsor
mesh term: Fecal Incontinence
mesh term: Rectal Diseases
mesh term: Constipation