<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/NCT01727388</url>
  </required_header>
  <id_info>
    <org_study_id>PI11-PR-REGIMBEAU</org_study_id>
    <secondary_id>2011-AO1485-36</secondary_id>
    <nct_id>NCT01727388</nct_id>
  </id_info>
  <brief_title>Informativeness to Digital Rectal Examination</brief_title>
  <acronym>RIFIONA</acronym>
  <official_title>Prospective Randomized Study Comparing the Results of Digital Rectal Examination in the Supine and Lateral Decubitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Digital rectal examination is an act clinically performed daily by physicians and surgeons.&#xD;
      It remains the key diagnostic test and directs the therapeutic management of cancer of the&#xD;
      lower and middle rectum. It can be done in two main positions: lateral decubitus, and supine.&#xD;
&#xD;
      However, no randomized study in colorectal surgery is not interested in evaluating the best&#xD;
      position to perform a full rectal exam.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>realization of a full digital rectal examination</measure>
    <time_frame>The consult could be done prior to the surgery or one month after the surgery</time_frame>
    <description>Full digital rectal examination is defined by a rectal examination for investigating the superior pole of the prostate, to examine the entire circumference and the rectal sphincter.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>assessment of sphincter according to the DRESS score</measure>
    <time_frame>The consult can be performed prior to the surgery or one month after the surgery</time_frame>
    <description>This score assesses the sphincter tone at rest and during exercise. This score classes the sphincter tone in both situations: tone undetectable (score = 0) to hypertonic sphincter that does not allow the introduction of a finger (score = 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>missing information during the rectal examination</measure>
    <time_frame>The consult can be performed prior to the surgery or one month after the surgery</time_frame>
    <description>This analysis aims to determine what information is missing most often in one group compared to another (height to digital rectal examination, circumference of the digital rectal examination , assessment of sphincter tone)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conversion rate decided by the examiner</measure>
    <time_frame>The consult can be performed prior to the surgery or one month after the surgery</time_frame>
    <description>the conversion rate decided by the examiner corresponds to the switch from one position to another</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the position by the patient</measure>
    <time_frame>The consult can be performed prior to the surgery or one month after the surgery</time_frame>
    <description>After the digital rectal examination, the examiner shows the patient a picture of the two positions and ask him the question: which position is the most embarrassing?</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Upper Rectum Cancer</condition>
  <condition>Diverticulitis</condition>
  <condition>Rectal Bleeding</condition>
  <condition>Hernia</condition>
  <arm_group>
    <arm_group_label>lateral decubitus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The digital rectal examination is performed in lateral decubitus i.e. curled up position . The patient in left lateral decubitus if the examiner is right handed and right lateral decubitus if the examiner is left handed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>supine decubitus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The digital rectal examination is performed supine, spread legs, feet on the examination table. The examiner is in the patient's right side if he is right handed and in the patient's left side if he is left-handed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>lateral decubitus</intervention_name>
    <arm_group_label>lateral decubitus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>supine decubitus</intervention_name>
    <arm_group_label>supine decubitus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  colon or upper rectum cancer operated or not&#xD;
&#xD;
          -  recurrent of colon or upper rectum cancer&#xD;
&#xD;
          -  rectal bleeding&#xD;
&#xD;
          -  hernia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  woman&#xD;
&#xD;
          -  paraplegic man&#xD;
&#xD;
          -  bedridden patient&#xD;
&#xD;
          -  current or previous pelvic radiotherapy&#xD;
&#xD;
          -  History of prostatectomy&#xD;
&#xD;
          -  emergency&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Amiens Universitary Hospital</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beauvais General Hospital</name>
      <address>
        <city>Beauvais</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 26, 2013</last_update_submitted>
  <last_update_submitted_qc>November 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rectal examination</keyword>
  <keyword>colorectal cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Diverticulitis</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/NCT01727388
org study id: PI11-PR-REGIMBEAU
secondary id: 2011-AO1485-36
nct id: NCT01727388
lead sponsor: 
has dmc: No
Digital rectal examination is an act clinically performed daily by physicians and surgeons.
      It remains the key diagnostic test and directs the therapeutic management of cancer of the
      lower and middle rectum. It can be done in two main positions: lateral decubitus, and supine.

      However, no randomized study in colorectal surgery is not interested in evaluating the best
      position to perform a full rectal exam.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: realization of a full digital rectal examination
time frame: The consult could be done prior to the surgery or one month after the surgery
description: Full digital rectal examination is defined by a rectal examination for investigating the superior pole of the prostate, to examine the entire circumference and the rectal sphincter.
measure: assessment of sphincter according to the DRESS score
time frame: The consult can be performed prior to the surgery or one month after the surgery
description: This score assesses the sphincter tone at rest and during exercise. This score classes the sphincter tone in both situations: tone undetectable (score = 0) to hypertonic sphincter that does not allow the introduction of a finger (score = 5)
measure: missing information during the rectal examination
time frame: The consult can be performed prior to the surgery or one month after the surgery
description: This analysis aims to determine what information is missing most often in one group compared to another (height to digital rectal examination, circumference of the digital rectal examination , assessment of sphincter tone)
measure: Conversion rate decided by the examiner
time frame: The consult can be performed prior to the surgery or one month after the surgery
description: the conversion rate decided by the examiner corresponds to the switch from one position to another
measure: Evaluation of the position by the patient
time frame: The consult can be performed prior to the surgery or one month after the surgery
description: After the digital rectal examination, the examiner shows the patient a picture of the two positions and ask him the question: which position is the most embarrassing?
arm group label: lateral decubitus
arm group type: Experimental
description: The digital rectal examination is performed in lateral decubitus i.e. curled up position . The patient in left lateral decubitus if the examiner is right handed and right lateral decubitus if the examiner is left handed.
arm group label: supine decubitus
arm group type: Active Comparator
description: The digital rectal examination is performed supine, spread legs, feet on the examination table. The examiner is in the patient's right side if he is right handed and in the patient's left side if he is left-handed.
intervention type: Procedure
intervention name: lateral decubitus
arm group label: lateral decubitus
intervention type: Procedure
intervention name: supine decubitus
arm group label: supine decubitus
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Rectal Neoplasms
mesh term: Diverticulitis