<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/NCT02196597</url>
  </required_header>
  <id_info>
    <org_study_id>DGNM_ARM</org_study_id>
    <nct_id>NCT02196597</nct_id>
  </id_info>
  <brief_title>Value of Anorectal Manometry Before Ileo- or Sigmoidostomy Closure After Rectal Resection</brief_title>
  <official_title>Prospective Multi-center Evaluation of the Value of Anorectal Manometry Before Closure of Protective Ileostomy or Sigmoidostomy After Rectal Resection in Patients With Rectal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>German Society for Neurogastroenterology and Motility</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>German Society for Neurogastroenterology and Motility</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: High prevalence of fecal incontinence after rectal resection in patients with&#xD;
      rectal carcinoma.&#xD;
&#xD;
      Hypothesis: Anorectal manometry done before ileostomy or sigmoidostomy closure can predict&#xD;
      fecal incontinence.&#xD;
&#xD;
      Methods: Anorectal manometry before, 1 month and 6 month after closure. Anorectal&#xD;
      endosonography before and 1 month after closure. Prediction of postoperative incontinence by&#xD;
      the surgeon (digital sphincter examination). Visual analog scales for continence, subjective&#xD;
      success of operation, and global well being; Wexner and Vaizey incontinence score; Parks&#xD;
      incontinence classification; Rockwood fecal incontinence quality of life score; each before,&#xD;
      1 and 6 month after closure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">January 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>predictive value of preoperative anorectal manometry for postoperative fecal incontinence</measure>
    <time_frame>6 month postoperative</time_frame>
    <description>Anorectal manometry is done preoperatively. Fecal incontinence is determined at 6 month postoperatively. Analysis of correlation between preoperative manometry parameter and incidence of postoperative fecal incontinence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fecal incontinence in patients with/without neoadjuvant radiochemotherapy</measure>
    <time_frame>six month postoperative</time_frame>
    <description>Comparison of the percentage of patients with postoperative fecal incontinence after rectal resection in patients with or without neoadjuvant radiochemotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>predictive value of the surgeon's preoperative evaluation</measure>
    <time_frame>six month postoperative</time_frame>
    <description>Clinical evaluation of the patient preoperatively with estimation (written statement) about postoperative continence/incontinence. Fecal incontinence is determined at 6 month postoperatively. Analysis of correlation between the surgeons´ predictions and the incidence of postoperative fecal incontinence</description>
  </secondary_outcome>
  <other_outcome>
    <measure>prediction of postoperative fecal incontinence by the score of Stadelmaier and Matzel (Score =18.230 - 0.94x anastomotic level - 0.18 x resting pressure + 3.72 x radiochemotherapy (done 1, not done 0)</measure>
    <time_frame>six month postoperative</time_frame>
    <description>Analysis of correlation between the preoperatively predicted Wexner score and the observed Wexner score six month postoperative.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Fecal Incontinence</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>resection with RCT</arm_group_label>
    <description>rectal resection in the case of rectal carcinoma with preoperative radiochemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>resection without RCT</arm_group_label>
    <description>patients with rectal resection without preoperative radiochemotherapy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        all patients operated for rectal carcinoma in three German centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients planned for ileo- or sigmoidostomy closure after rectal resection for&#xD;
             rectal carcinoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  preoperative incontinence for solid stool&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  latex allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Pehl, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>German Society for Neurogastroenterology and Motility</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christian Pehl, MD</last_name>
    <phone>+49 (0)8741 603152</phone>
    <email>christian.pehl@kkh-vilsbiburg.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hosptial Landshut-Achdorf</name>
      <address>
        <city>Landshut</city>
        <zip>84036</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johannes Schmidt, MD</last_name>
      <phone>0049 871 4042770</phone>
      <email>johannes.schmidt@lakumed.de</email>
    </contact>
    <investigator>
      <last_name>Johannes Schmidt, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Memmingen</name>
      <address>
        <city>Memmingen</city>
        <zip>87700</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Albert Pfeiffer, MD</last_name>
      <phone>0049 8331 702640</phone>
      <email>Silke.Eipper@klinikum-memmingen.de</email>
    </contact>
    <investigator>
      <last_name>Albert Pfeiffer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Vilsbiburg</name>
      <address>
        <city>Vilsbiburg</city>
        <zip>81437</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Christian Pehl, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nikolaus Steigemann, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.neurogastro.de</url>
    <description>Homepage of the German Society for Neurogastroenterology and Motility</description>
  </link>
  <results_reference>
    <citation>Stadelmaier U, Bittorf B, Meyer M, Hohenberger W, Matzel KE. [Can continence function after rectal resection be prognostically estimated?]. Chirurg. 2000 Aug;71(8):932-8. doi: 10.1007/s001040051158. German.</citation>
    <PMID>11013813</PMID>
  </results_reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>November 4, 2013</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>German Society for Neurogastroenterology and Motility</investigator_affiliation>
    <investigator_full_name>Dr. Christian Pehl</investigator_full_name>
    <investigator_title>Chairman</investigator_title>
  </responsible_party>
  <keyword>anorectal manometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</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/NCT02196597
org study id: DGNM_ARM
nct id: NCT02196597
lead sponsor: 
has dmc: No
Background: High prevalence of fecal incontinence after rectal resection in patients with
      rectal carcinoma.

      Hypothesis: Anorectal manometry done before ileostomy or sigmoidostomy closure can predict
      fecal incontinence.

      Methods: Anorectal manometry before, 1 month and 6 month after closure. Anorectal
      endosonography before and 1 month after closure. Prediction of postoperative incontinence by
      the surgeon (digital sphincter examination). Visual analog scales for continence, subjective
      success of operation, and global well being; Wexner and Vaizey incontinence score; Parks
      incontinence classification; Rockwood fecal incontinence quality of life score; each before,
      1 and 6 month after closure.
observational model: Cohort
time perspective: Prospective
measure: predictive value of preoperative anorectal manometry for postoperative fecal incontinence
time frame: 6 month postoperative
description: Anorectal manometry is done preoperatively. Fecal incontinence is determined at 6 month postoperatively. Analysis of correlation between preoperative manometry parameter and incidence of postoperative fecal incontinence.
measure: fecal incontinence in patients with/without neoadjuvant radiochemotherapy
time frame: six month postoperative
description: Comparison of the percentage of patients with postoperative fecal incontinence after rectal resection in patients with or without neoadjuvant radiochemotherapy
measure: predictive value of the surgeon's preoperative evaluation
time frame: six month postoperative
description: Clinical evaluation of the patient preoperatively with estimation (written statement) about postoperative continence/incontinence. Fecal incontinence is determined at 6 month postoperatively. Analysis of correlation between the surgeons´ predictions and the incidence of postoperative fecal incontinence
measure: prediction of postoperative fecal incontinence by the score of Stadelmaier and Matzel (Score =18.230 - 0.94x anastomotic level - 0.18 x resting pressure + 3.72 x radiochemotherapy (done 1, not done 0)
time frame: six month postoperative
description: Analysis of correlation between the preoperatively predicted Wexner score and the observed Wexner score six month postoperative.
arm group label: resection with RCT
description: rectal resection in the case of rectal carcinoma with preoperative radiochemotherapy
arm group label: resection without RCT
description: patients with rectal resection without preoperative radiochemotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian Pehl, MD
role: Principal Investigator
affiliation: German Society for Neurogastroenterology and Motility
last name: Christian Pehl, MD
phone: +49 (0)8741 603152
email: christian.pehl@kkh-vilsbiburg.de
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
country: Germany
url: http://www.neurogastro.de
description: Homepage of the German Society for Neurogastroenterology and Motility
citation: Stadelmaier U, Bittorf B, Meyer M, Hohenberger W, Matzel KE. [Can continence function after rectal resection be prognostically estimated?]. Chirurg. 2000 Aug;71(8):932-8. doi: 10.1007/s001040051158. German.
PMID: 11013813
responsible party type: Principal Investigator
investigator affiliation: German Society for Neurogastroenterology and Motility
investigator full name: Dr. Christian Pehl
investigator title: Chairman
mesh term: Fecal Incontinence