<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/NCT01706549</url>
  </required_header>
  <id_info>
    <org_study_id>R11190</org_study_id>
    <nct_id>NCT01706549</nct_id>
  </id_info>
  <brief_title>Clinical Analysis of Pain After Hysterectomy</brief_title>
  <official_title>Chronic Pain After Hysterectomy, Qualitative Analysis of Pain and Its Impact on Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tampere University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tampere University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical&#xD;
      examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The&#xD;
      aims of the study are:&#xD;
&#xD;
        1. to reveal whether the pain is postsurgical in nature, or if there are any other reasons&#xD;
           for the pain.&#xD;
&#xD;
        2. to reveal the type of pain, neuropathic, nociceptive or idiopathic.&#xD;
&#xD;
        3. to reveal the impact of pain on quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical&#xD;
      examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. All&#xD;
      patients were treated in Pirkanmaa District Hospital and the anesthesia was either&#xD;
      propofol-infusion or sevoflurane gas with remifentanil-infusion.&#xD;
&#xD;
      6months after the surgery, questionnaires about pelvic pain were sent to the patients.&#xD;
      Patients still having pain at that time, were invited for detailed sensory and gynecological&#xD;
      examinations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Type of Chronic Pain After Hysterectomy</measure>
    <time_frame>1-3 years after hysterectomy</time_frame>
    <description>Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life After Hysterectomy</measure>
    <time_frame>1-3 years after hysterectomy</time_frame>
    <description>Quality of life as measured by the SF-36, which consists of 8 scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Is the Pain Due to Hysterectomy?</measure>
    <time_frame>1-3 years</time_frame>
    <description>Number of patients having posthysterectomy pain versus other pain</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Posthysterectomy pain</arm_group_label>
    <description>Observational study on posthysterectomy pain</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergone hysterectomy for 1-3 years previously and suffering from persistent pain 6&#xD;
        months after surgery. The patients are invited to participate in this study, if they have&#xD;
        participated in previous studies &quot;Sevoflurane, Propofol, Postoperative pain&quot; by Yli-Hankala&#xD;
        and Pokkinen and study:&quot; Vaginal hysterectomy, laparoscopic hysterectomy, postoperative&#xD;
        pain&quot; by Yli-Hankala and Pokkinen.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hysterectomy 1-3 years previously&#xD;
&#xD;
          -  suffering from pain 6months postsurgically&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Satu Pokkinen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tampere University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maija-Liisa Kalliomäki, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Tampere University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kari Nieminen, MD, Doc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tampere University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <zip>33200</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>December 19, 2014</results_first_submitted>
  <results_first_submitted_qc>June 1, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 2, 2015</results_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic pain</keyword>
  <keyword>Hysterectomy</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>January 2012-December 2013. Patients recruited from previous studies. Clinical evaluation at the Hospital on the basis of volunteering.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Posthysterectomy Pain</title>
          <description>Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients undergone hysterectomy and reportteri to have SUFFERED from pain 6 months postoperatively and volunteered for a clinical examination.</population>
      <group_list>
        <group group_id="B1">
          <title>Postoperative Pain</title>
          <description>Observational study on posthysterectomy pain</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Finland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Quality of life (SF-36)</title>
          <description>All dimensions are mean of points from 0-100, where 100 is the best score. Getting 0 points equals to poor performance.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Physical Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.9" spread="29.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Physical</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.8" spread="45.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Emotional</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.1" spread="43.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vitality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.3" spread="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.0" spread="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.6" spread="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodily Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.5" spread="29.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.8" spread="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Type of Chronic Pain After Hysterectomy</title>
        <description>Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.</description>
        <time_frame>1-3 years after hysterectomy</time_frame>
        <population>Women undergone hysterectomy previously and reported having pain at the site of surgery six months after surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Posthysterectomy Pain</title>
            <description>Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.</description>
          </group>
        </group_list>
        <measure>
          <title>Type of Chronic Pain After Hysterectomy</title>
          <description>Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.</description>
          <population>Women undergone hysterectomy previously and reported having pain at the site of surgery six months after surgery</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Probable neuropathic pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Possible neuropathic pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subsided pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other type of pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life After Hysterectomy</title>
        <description>Quality of life as measured by the SF-36, which consists of 8 scales.</description>
        <time_frame>1-3 years after hysterectomy</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Is the Pain Due to Hysterectomy?</title>
        <description>Number of patients having posthysterectomy pain versus other pain</description>
        <time_frame>1-3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Posthysterectomy Pain</title>
            <description>Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.</description>
          </group>
        </group_list>
        <measure>
          <title>Is the Pain Due to Hysterectomy?</title>
          <description>Number of patients having posthysterectomy pain versus other pain</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>May 11th 2012-November 15th 2013</time_frame>
      <desc>This was an observational study, thus no adverse events were anticipated.</desc>
      <group_list>
        <group group_id="E1">
          <title>Posthysterectomy Pain</title>
          <description>This was an observational study, thus no adverse events were collected.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Low participation rate. Inadequate filling of questionnaires. Time from surgery to clinical examination varied from 10 to 44 months. No preoperative quality of life measure.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>MD Satu Pokkinen</name_or_title>
      <organization>Tampere University Hospital</organization>
      <phone>+3583311611</phone>
      <email>Satu.pokkinen@pshp.fi</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01706549
org study id: R11190
nct id: NCT01706549
lead sponsor: 
has dmc: No
Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical
      examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The
      aims of the study are:

        1. to reveal whether the pain is postsurgical in nature, or if there are any other reasons
           for the pain.

        2. to reveal the type of pain, neuropathic, nociceptive or idiopathic.

        3. to reveal the impact of pain on quality of life.
Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical
      examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. All
      patients were treated in Pirkanmaa District Hospital and the anesthesia was either
      propofol-infusion or sevoflurane gas with remifentanil-infusion.

      6months after the surgery, questionnaires about pelvic pain were sent to the patients.
      Patients still having pain at that time, were invited for detailed sensory and gynecological
      examinations.
observational model: Cohort
time perspective: Prospective
measure: Type of Chronic Pain After Hysterectomy
time frame: 1-3 years after hysterectomy
description: Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.
measure: Quality of Life After Hysterectomy
time frame: 1-3 years after hysterectomy
description: Quality of life as measured by the SF-36, which consists of 8 scales.
measure: Is the Pain Due to Hysterectomy?
time frame: 1-3 years
description: Number of patients having posthysterectomy pain versus other pain
arm group label: Posthysterectomy pain
description: Observational study on posthysterectomy pain
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
last name: Satu Pokkinen, MD
role: Principal Investigator
affiliation: Tampere University Hospital
last name: Maija-Liisa Kalliomäki, MD, PhD
role: Study Director
affiliation: Tampere University Hospital
last name: Kari Nieminen, MD, Doc
role: Principal Investigator
affiliation: Tampere University Hospital
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Low participation rate. Inadequate filling of questionnaires. Time from surgery to clinical examination varied from 10 to 44 months. No preoperative quality of life measure.
point of contact: 