<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/NCT03819257</url>
  </required_header>
  <id_info>
    <org_study_id>GA18/113514</org_study_id>
    <nct_id>NCT03819257</nct_id>
  </id_info>
  <brief_title>Anorectal Function in Perianal Crohn's Disease</brief_title>
  <official_title>Evaluation of Anorectal Function in Perianal Crohn's Disease: a Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Leeds Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Leeds Teaching Hospitals NHS Trust</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>
      Perianal Crohn's disease is a disabling disease associated with increased morbidity and&#xD;
      impaired quality of life. It is associated with pain, discharge, fecal incontinence and&#xD;
      sexual and psychological impairment. In refractory cases, a stoma may be necessary. A higher&#xD;
      prevalence is seen with increasing Crohn's disease duration and appears to vary according to&#xD;
      the disease location. The presence of symptoms associated with anorectal dysfunction, such as&#xD;
      fecal incontinence, can sometimes poorly correlate with the presence of anal sphincter&#xD;
      abnormalities. Moreover, even in patients without symptoms, the presence of anal sphincter&#xD;
      abnormalities may have important implications for the future selection of type of delivery,&#xD;
      and might even pose a contra-indication for certain types of anorectal surgeries.&#xD;
&#xD;
      Studies evaluating possible chronic complications of perianal Crohn's disease on anorectal&#xD;
      function are lacking. There is a need for a better understanding of the chronic complications&#xD;
      of this disease, and the role of high-resolution anorectal manometry in diagnosing these&#xD;
      abnormalities during follow-up of these patients. This study will evaluate the chronic&#xD;
      repercussions of perianal Crohn's disease in patients with a previous anal fistula and/or&#xD;
      abscess that has healed and/or is inactive.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2019</start_date>
  <completion_date type="Actual">February 22, 2020</completion_date>
  <primary_completion_date type="Actual">February 22, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Resting pressure, squeezing pressure, anorectal pressure changes during cough, anorectal pressure changes during simulated defecation, presence of a rectoanal inhibitory reflex and assessment of rectal sensitivity to distension.</measure>
    <time_frame>30 minutes</time_frame>
    <description>Evaluated by high-resolution anorectal manometry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anal sphincters integrity.</measure>
    <time_frame>5 minutes</time_frame>
    <description>Evaluated by endoanal ultrasound.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ballon expulsion test duration.</measure>
    <time_frame>3 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of symptoms suggesting obstructed defection.</measure>
    <time_frame>5 minutes</time_frame>
    <description>Prolonged and unsuccessful straining at stool, self-digitation for defecation, sense of incomplete evacuation or sensation of anorectal obstruction/blockage and a stool frequency of less than three times per week.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Wexner score (fecal incontinence score).</measure>
    <time_frame>5 minutes</time_frame>
    <description>5 items score, including solid, liquid, gas incontinence, wearing pads and lifestyle alterations, scored from 0 (normal) to 4 (more severe).</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>Patients with perianal Crohn's disease.</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Endoanal ultrasound</intervention_name>
    <description>For the assessment of the internal and external anal sphincter integrity. To evaluate fistulas/perianal abscess and seton placement.</description>
    <arm_group_label>Patients with perianal Crohn's disease.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>High-resolution anorectal manometry</intervention_name>
    <description>rest - basal anal pressures at rest over 60 s&#xD;
squeeze - anal pressure during voluntary effort; long squeeze - anal pressure during sustained voluntary effort&#xD;
cough - anorectal pressure changes during cough&#xD;
push - anorectal pressure changes during simulated defecation&#xD;
rectoanal inhibitory reflex - reflex anal response to rectal distension&#xD;
rectal sensation - assessment of rectal sensitivity to distension.</description>
    <arm_group_label>Patients with perianal Crohn's disease.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Balloon expulsion test</intervention_name>
    <description>A non-latex balloon will be inserted in the rectum after applying lubricating gel. This balloon is then filled with 50ml of warm water. The patient is ask to sit on a commode and to try to expel the device in privacy, while the time is being recorded. The test ends when the patient expelled the balloon or when 3 minutes are reach.</description>
    <arm_group_label>Patients with perianal Crohn's disease.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients attending hospital with diagnosed perianal Crohn's disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 18 and ≤ 75 year-old patients&#xD;
&#xD;
          2. CD in clinical remission, defined by a Harvey-Bradshaw index &lt;5&#xD;
&#xD;
          3. Perianal CD history, defined by the presence of a perianal fistula and/or abscess that&#xD;
             were treated/heal/inactive&#xD;
&#xD;
          4. Perianal Disease Activity Index (PDAI) of ≤4&#xD;
&#xD;
          5. Asymptomatic or symptomatic patients (anorectal symptoms) will be included, as long&#xD;
             they fulfill the other inclusion criteria, like for anorectal symptomatic patients&#xD;
             having a PDAI≤4&#xD;
&#xD;
          6. Endoanal ultrasound without an image compatible with new/non-treated abscess or&#xD;
             perianal fistula&#xD;
&#xD;
          7. Both previous simple or complex perianal fistula (according to the American College of&#xD;
             Gastroenterology) will be considered.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women with previous vaginal delivery&#xD;
&#xD;
          2. Ileostomy&#xD;
&#xD;
          3. Previous anorectal surgery as hemorrhoidectomy or lateral sphincterotomy&#xD;
&#xD;
          4. Active rectal disease. No rectal involvement will be defined by no previous rectal&#xD;
             involvement ever described or if previous involvement, endoscopy within 18 months&#xD;
             showing no current involvement&#xD;
&#xD;
          5. Previous or current anal fissure&#xD;
&#xD;
          6. Anal stricture&#xD;
&#xD;
          7. Current or previous rectovaginal fistula (previous/last pelvic MRI).&#xD;
&#xD;
        A previous seton placement, abscess drainage, fistulotomy and lay open fistula are not an&#xD;
        exclusion criteria. Patients with a current seton can only be included if the seton was&#xD;
        place more than 24 weeks ago, and the endoanal ultrasound does not show any new/non-treated&#xD;
        perianal fistula/abscess.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Leeds Teaching Hospital NHS Trust</name>
      <address>
        <city>Leeds</city>
        <zip>LS7 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</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/NCT03819257
org study id: GA18/113514
nct id: NCT03819257
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Perianal Crohn's disease is a disabling disease associated with increased morbidity and
      impaired quality of life. It is associated with pain, discharge, fecal incontinence and
      sexual and psychological impairment. In refractory cases, a stoma may be necessary. A higher
      prevalence is seen with increasing Crohn's disease duration and appears to vary according to
      the disease location. The presence of symptoms associated with anorectal dysfunction, such as
      fecal incontinence, can sometimes poorly correlate with the presence of anal sphincter
      abnormalities. Moreover, even in patients without symptoms, the presence of anal sphincter
      abnormalities may have important implications for the future selection of type of delivery,
      and might even pose a contra-indication for certain types of anorectal surgeries.

      Studies evaluating possible chronic complications of perianal Crohn's disease on anorectal
      function are lacking. There is a need for a better understanding of the chronic complications
      of this disease, and the role of high-resolution anorectal manometry in diagnosing these
      abnormalities during follow-up of these patients. This study will evaluate the chronic
      repercussions of perianal Crohn's disease in patients with a previous anal fistula and/or
      abscess that has healed and/or is inactive.
observational model: Cohort
time perspective: Prospective
measure: Resting pressure, squeezing pressure, anorectal pressure changes during cough, anorectal pressure changes during simulated defecation, presence of a rectoanal inhibitory reflex and assessment of rectal sensitivity to distension.
time frame: 30 minutes
description: Evaluated by high-resolution anorectal manometry.
measure: Anal sphincters integrity.
time frame: 5 minutes
description: Evaluated by endoanal ultrasound.
measure: Ballon expulsion test duration.
time frame: 3 minutes
measure: Presence of symptoms suggesting obstructed defection.
time frame: 5 minutes
description: Prolonged and unsuccessful straining at stool, self-digitation for defecation, sense of incomplete evacuation or sensation of anorectal obstruction/blockage and a stool frequency of less than three times per week.
measure: Wexner score (fecal incontinence score).
time frame: 5 minutes
description: 5 items score, including solid, liquid, gas incontinence, wearing pads and lifestyle alterations, scored from 0 (normal) to 4 (more severe).
arm group label: Patients with perianal Crohn's disease.
intervention type: Diagnostic Test
intervention name: Endoanal ultrasound
description: For the assessment of the internal and external anal sphincter integrity. To evaluate fistulas/perianal abscess and seton placement.
arm group label: Patients with perianal Crohn's disease.
intervention type: Diagnostic Test
intervention name: High-resolution anorectal manometry
description: rest - basal anal pressures at rest over 60 s
squeeze - anal pressure during voluntary effort; long squeeze - anal pressure during sustained voluntary effort
cough - anorectal pressure changes during cough
push - anorectal pressure changes during simulated defecation
rectoanal inhibitory reflex - reflex anal response to rectal distension
rectal sensation - assessment of rectal sensitivity to distension.
arm group label: Patients with perianal Crohn's disease.
intervention type: Diagnostic Test
intervention name: Balloon expulsion test
description: A non-latex balloon will be inserted in the rectum after applying lubricating gel. This balloon is then filled with 50ml of warm water. The patient is ask to sit on a commode and to try to expel the device in privacy, while the time is being recorded. The test ends when the patient expelled the balloon or when 3 minutes are reach.
arm group label: Patients with perianal Crohn's disease.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Crohn Disease