<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/NCT01706601</url>
  </required_header>
  <id_info>
    <org_study_id>2010/1108-31/1</org_study_id>
    <nct_id>NCT01706601</nct_id>
  </id_info>
  <brief_title>Patients With Hemorrhoids Referred to a Surgical Specialist Department</brief_title>
  <official_title>Patients With Hemorrhoids Referred to a Surgical Specialist Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ersta Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hemorrhoids is the most common disease in rectum with a prevalence of 30 % of population.&#xD;
      This means that many patients are referred to surgical specialist reception with diagnosis&#xD;
      hemorrhoidal disease. The aim of this study is to describe population of patients with&#xD;
      hemorrhoidal disease that are referred to a specialised colorectal unit and to determine what&#xD;
      treatment they are given at a general practitioner as well as in colorectal unit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2011</start_date>
  <primary_completion_date type="Anticipated">December 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correct diagnosis?</measure>
    <time_frame>patients visiting Ersta Hospital between 2007-2009</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>treatment of hemorrhoids</measure>
    <time_frame>patients visiting Ersta Hospital between 2007-2009</time_frame>
    <description>Surgical or conservative treatment, results and number of patients in the groups</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Examination/treatment</measure>
    <time_frame>Before visiting Ersta hospital</time_frame>
    <description>Examination and treatment given by general practitioner</description>
  </other_outcome>
  <other_outcome>
    <measure>Operation/complication</measure>
    <time_frame>postoperatively</time_frame>
    <description>Which operations were performed, complications?, reinterventions?</description>
  </other_outcome>
  <other_outcome>
    <measure>genus</measure>
    <time_frame>between 2007-2009</time_frame>
    <description>Did men and women got the same treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Treated elsewhere</measure>
    <time_frame>after compleated treatment at Ersta hospital</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Hemorrhoids</condition>
  <arm_group>
    <arm_group_label>Hemorrhoids</arm_group_label>
    <description>Patient with hemorrhoids</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients whith hemorrhoids&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients with diagnosis hemorrhoidal disease that are referred to a surgical&#xD;
             specialist department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Solveig Elmér, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ersta hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>116 91</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>March 9, 2015</last_update_submitted>
  <last_update_submitted_qc>March 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Solveig Elmér</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhoids</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/NCT01706601
org study id: 2010/1108-31/1
nct id: NCT01706601
lead sponsor: 
collaborator: 
has dmc: No
Hemorrhoids is the most common disease in rectum with a prevalence of 30 % of population.
      This means that many patients are referred to surgical specialist reception with diagnosis
      hemorrhoidal disease. The aim of this study is to describe population of patients with
      hemorrhoidal disease that are referred to a specialised colorectal unit and to determine what
      treatment they are given at a general practitioner as well as in colorectal unit.
observational model: Cohort
time perspective: Retrospective
measure: Correct diagnosis?
time frame: patients visiting Ersta Hospital between 2007-2009
measure: treatment of hemorrhoids
time frame: patients visiting Ersta Hospital between 2007-2009
description: Surgical or conservative treatment, results and number of patients in the groups
measure: Examination/treatment
time frame: Before visiting Ersta hospital
description: Examination and treatment given by general practitioner
measure: Operation/complication
time frame: postoperatively
description: Which operations were performed, complications?, reinterventions?
measure: genus
time frame: between 2007-2009
description: Did men and women got the same treatment
measure: Treated elsewhere
time frame: after compleated treatment at Ersta hospital
arm group label: Hemorrhoids
description: Patient with hemorrhoids
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Solveig Elmér, MD
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Solveig Elmér
investigator title: MD
mesh term: Hemorrhoids