<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/NCT02994524</url>
  </required_header>
  <id_info>
    <org_study_id>06379</org_study_id>
    <nct_id>NCT02994524</nct_id>
  </id_info>
  <brief_title>Intersphincteric Approach to Perianal Fistula With High Risk for Postoperative Fecal Incontinence</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yasser Mohamed Abdel-samii</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      .Rerouting operation takes the advantage of minimal recurrence rate as well as minimal&#xD;
      incontinence that is associated with less sphincter division,It is indicated in patients with&#xD;
      transsphincteric fistula in whom lay open is expected to be associated with significant&#xD;
      incontinence .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lay open is the classic surgical management for Peri Anal fistula,however division of&#xD;
      significant portion of anal sphincter may be divided with postoperative fecal&#xD;
      incontinence,Many surgical techniques have been described for sphincter preservation ,But&#xD;
      unfortunately associated high recurrence rate.Rerouting operation takes the advantage of&#xD;
      minimal recurrence rate as well as minimal incontinence that is associated with less&#xD;
      sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open&#xD;
      is expected to be associated with significant incontinence .The operation is done in tow&#xD;
      stages ,the first is to mobilize the transsphincteric part into the inter sphincteric plane&#xD;
      thus converting it to intersphincteric fistula which is then laid open , with division of&#xD;
      internal sphincter with preserving external sphincter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Rerouting technique decrease incidence of fecal incontinice after high transsphincteric perianal fistula surgery .</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>High Transsphincteric Perianal Fistula</condition>
  <arm_group>
    <arm_group_label>transsphincteric perianal fistula</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Rerouting technique done in patients with high transsphincteric fistula or with high internal opening.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rerouting technique for transsphincteric perianal fistula</intervention_name>
    <arm_group_label>transsphincteric perianal fistula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  High arching transsphincteric fistula&#xD;
&#xD;
          -  Transsphincteric fistula with high internal opening&#xD;
&#xD;
          -  Transsphincteric fistula with short anal canal.&#xD;
&#xD;
          -  Horseshoe perianal fistula fulfilling above criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transsphincteric fistula.&#xD;
&#xD;
          -  Low perianal fistula.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Yasser Mohamed Abdel-samii</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02994524
org study id: 06379
nct id: NCT02994524
lead sponsor: 
has dmc: Yes
.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal
      incontinence that is associated with less sphincter division,It is indicated in patients with
      transsphincteric fistula in whom lay open is expected to be associated with significant
      incontinence .
Lay open is the classic surgical management for Peri Anal fistula,however division of
      significant portion of anal sphincter may be divided with postoperative fecal
      incontinence,Many surgical techniques have been described for sphincter preservation ,But
      unfortunately associated high recurrence rate.Rerouting operation takes the advantage of
      minimal recurrence rate as well as minimal incontinence that is associated with less
      sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open
      is expected to be associated with significant incontinence .The operation is done in tow
      stages ,the first is to mobilize the transsphincteric part into the inter sphincteric plane
      thus converting it to intersphincteric fistula which is then laid open , with division of
      internal sphincter with preserving external sphincter.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rerouting technique decrease incidence of fecal incontinice after high transsphincteric perianal fistula surgery .
time frame: one year
arm group label: transsphincteric perianal fistula
arm group type: Other
description: Rerouting technique done in patients with high transsphincteric fistula or with high internal opening.
intervention type: Procedure
intervention name: Rerouting technique for transsphincteric perianal fistula
arm group label: transsphincteric perianal fistula
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams University
investigator full name: Yasser Mohamed Abdel-samii
investigator title: Lecturer
mesh term: Fistula
sharing ipd: Undecided