<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/NCT02202252</url>
  </required_header>
  <id_info>
    <org_study_id>DGC-45</org_study_id>
    <nct_id>NCT02202252</nct_id>
  </id_info>
  <brief_title>Single Versus Double Drains After Mastectomy</brief_title>
  <official_title>Comparison of Single Versus Double Drains After Modified Radical Mastectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Diskapi Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara Diskapi Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is not known whether decreasing the number of drains used decreases patients' discomfort&#xD;
      and duration of hospital stay without increasing seroma formation after mastectomies.&#xD;
&#xD;
      Hypothesis. Use of one drain increases patient comfort without increasing seroma formation&#xD;
      after modified radical mastectomy (MRM) as compared to double drains.&#xD;
&#xD;
      Material and Method: Sixty patients undergoing MRM at Diskapi Yildirim Beyazit Training and&#xD;
      Research Hospital will be randomised into single versus double drains groups. A negative&#xD;
      pressure drain will be inserted below the lower flap directing to the axilla in the single&#xD;
      drain group or two similar drains will be inserted into the axilla and below the lower flap&#xD;
      in the double drains group. Drains will be removed if the output is less than 30 ml. Seroma&#xD;
      is defined as fluid accumulation below the flaps and will be examined daily after the&#xD;
      operation. One day after removal of the drains seroma under the flaps and in the axilla will&#xD;
      be examined by ultrasonography. Age, body mass index smoking history, coexisting diseases of&#xD;
      the patients duration of the hospital stay, duration of the drains in place, total drain&#xD;
      output in the first three days after the operation and the need and frequency of aspirations&#xD;
      due to seroma formation will be recorded. Patient comfort was measured with a comfort scale&#xD;
      between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep&#xD;
      disturbances caused by the drains, The duration of the longer staying drain in the double&#xD;
      drain group will be recorded for the duration of the drain in place parameter.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Seroma is one of the most common complications after mastectomies. Seroma&#xD;
      formation results in delays in wound healing, incisional dehiscence, infections and long&#xD;
      hospital stay. Although there are studies proving that drains do not prevent seroma&#xD;
      formation, the use of drains for that purpose is still very common. Decreasing the number of&#xD;
      drains used after mastectomies has been shown to decrease patients' discomfort and duration&#xD;
      of hospital stay without increasing seroma formation.&#xD;
&#xD;
      Objective: To investigate the effects of single versus double drains on patient comfort and&#xD;
      seroma formation after modified radical mastectomy (MRM) Material and Method: Sixty patients&#xD;
      undergoing MRM at Diskapi Yildirim Beyazit Training and Research Hospital will be randomised&#xD;
      into single versus double drains groups. A negative pressure drain will be inserted below the&#xD;
      lower flap directing to the axilla in the single drain group or two similar drains will be&#xD;
      inserted into the axilla and below the lower flap in the double drains group. Drains will be&#xD;
      removed if the output is less than 30 ml. Seroma is defined as fluid accumulation below the&#xD;
      flaps and will be examined daily after the operation. One day after removal of the drains&#xD;
      seroma under the flaps and in the axilla will be examined by ultrasonography. Age, body mass&#xD;
      index smoking history, coexisting diseases of the patients duration of the hospital stay,&#xD;
      duration of the drains in place, total drain output in the first three days after the&#xD;
      operation and the need and frequency of aspirations due to seroma formation will be recorded.&#xD;
      Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain,&#xD;
      pain caused by the drains, discomfort or sleep disturbances caused by the drains, The&#xD;
      duration of the longer staying drain in the double drain group will be recorded for the&#xD;
      duration of the drain in place parameter. Two groups will be compared with chi-square,&#xD;
      student's t-test or Mann-Whitney U test. P&lt;0.005 will be considered as significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Comfort Scale</measure>
    <time_frame>Postoperative 5 days</time_frame>
    <description>Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seroma Formation</measure>
    <time_frame>Twenty-four hours after removal of the drains up to 4 weeks</time_frame>
    <description>Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography..</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 5 days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Mastectomy</condition>
  <arm_group>
    <arm_group_label>Single drain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Double drain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Insertion of a single drain</intervention_name>
    <description>A negative pressure drain will be inserted below the lower flap directing to the axilla.</description>
    <arm_group_label>Single drain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Insertion of double drains</intervention_name>
    <description>Two drains will be inserted into the axilla and below the lower flap in the double drains group.</description>
    <arm_group_label>Double drain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasonography after removal of the drains</intervention_name>
    <description>One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.</description>
    <arm_group_label>Double drain</arm_group_label>
    <arm_group_label>Single drain</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Breast cancer&#xD;
&#xD;
          -  Modified radical mastectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Distant metastasis&#xD;
&#xD;
          -  Male breast cancer&#xD;
&#xD;
          -  Bleeding diathesis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Diskapi Training and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06110</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Akinci M, Cetin B, Aslan S, Kulacoglu H. Factors affecting seroma formation after mastectomy with full axillary dissection. Acta Chir Belg. 2009 Jul-Aug;109(4):481-3. doi: 10.1080/00015458.2009.11680464.</citation>
    <PMID>19803259</PMID>
  </reference>
  <reference>
    <citation>Aitken DR, Minton JP. Complications associated with mastectomy. Surg Clin North Am. 1983 Dec;63(6):1331-52. doi: 10.1016/s0039-6109(16)43192-0. No abstract available.</citation>
    <PMID>6359504</PMID>
  </reference>
  <reference>
    <citation>Jain PK, Sowdi R, Anderson AD, MacFie J. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Br J Surg. 2004 Jan;91(1):54-60. doi: 10.1002/bjs.4435.</citation>
    <PMID>14716794</PMID>
  </reference>
  <reference>
    <citation>Talbot ML, Magarey CJ. Reduced use of drains following axillary lymphadenectomy for breast cancer. ANZ J Surg. 2002 Jul;72(7):488-90. doi: 10.1046/j.1445-2197.2002.02456.x.</citation>
    <PMID>12123509</PMID>
  </reference>
  <reference>
    <citation>Saratzis A, Soumian S, Willetts R, Rastall S, Stonelake PS. Use of multiple drains after mastectomy is associated with more patient discomfort and longer postoperative stay. Clin Breast Cancer. 2009 Nov;9(4):243-6. doi: 10.3816/CBC.2009.n.041.</citation>
    <PMID>19933080</PMID>
  </reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <results_first_submitted>March 9, 2015</results_first_submitted>
  <results_first_submitted_qc>March 25, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 10, 2015</results_first_posted>
  <last_update_submitted>March 25, 2015</last_update_submitted>
  <last_update_submitted_qc>March 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara Diskapi Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Melih Akinci</investigator_full_name>
    <investigator_title>Melih Akinci</investigator_title>
  </responsible_party>
  <keyword>Patient comfort</keyword>
  <keyword>Drains</keyword>
  <keyword>Breast cancer</keyword>
  <keyword>Modified radical mastectomy</keyword>
  <keyword>Seroma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The recruitment period: July 2014-february 2015 Location: Dıskapi Research and training Hospital General Surgery Clinic</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Single Drain</title>
          <description>Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.&#xD;
Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.</description>
        </group>
        <group group_id="P2">
          <title>Double Drain</title>
          <description>Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.&#xD;
Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Single Drain</title>
          <description>Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.&#xD;
Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.</description>
        </group>
        <group group_id="B2">
          <title>Double Drain</title>
          <description>Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.&#xD;
Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </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="54.1" spread="11.6"/>
                    <measurement group_id="B2" value="53.9" spread="11.5"/>
                    <measurement group_id="B3" value="54" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</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="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Comfort Scale</title>
        <description>Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).</description>
        <time_frame>Postoperative 5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Drain</title>
            <description>Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.&#xD;
Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.</description>
          </group>
          <group group_id="O2">
            <title>Double Drain</title>
            <description>Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.&#xD;
Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Comfort Scale</title>
          <description>Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="8"/>
                    <measurement group_id="O2" value="3" lower_limit="1" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.490</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seroma Formation</title>
        <description>Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography..</description>
        <time_frame>Twenty-four hours after removal of the drains up to 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Drain</title>
            <description>Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.&#xD;
Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.</description>
          </group>
          <group group_id="O2">
            <title>Double Drain</title>
            <description>Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.&#xD;
Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.</description>
          </group>
        </group_list>
        <measure>
          <title>Seroma Formation</title>
          <description>Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography..</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.035</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Length of Hospital Stay</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Drain</title>
            <description>Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.&#xD;
Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.</description>
          </group>
          <group group_id="O2">
            <title>Double Drain</title>
            <description>Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.&#xD;
Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.&#xD;
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="2" upper_limit="7"/>
                    <measurement group_id="O2" value="3" lower_limit="2" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.819</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Single Drain</title>
          <description>Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.</description>
        </group>
        <group group_id="E2">
          <title>Double Drain</title>
          <description>Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.</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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <point_of_contact>
      <name_or_title>Melih Akinci, MD, Associate Prof</name_or_title>
      <organization>Diskapi Training and Research Hospital</organization>
      <phone>90 312 5962080</phone>
      <email>melihakinci@yahoo.com</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/NCT02202252
org study id: DGC-45
nct id: NCT02202252
lead sponsor: 
has dmc: No
It is not known whether decreasing the number of drains used decreases patients' discomfort
      and duration of hospital stay without increasing seroma formation after mastectomies.

      Hypothesis. Use of one drain increases patient comfort without increasing seroma formation
      after modified radical mastectomy (MRM) as compared to double drains.

      Material and Method: Sixty patients undergoing MRM at Diskapi Yildirim Beyazit Training and
      Research Hospital will be randomised into single versus double drains groups. A negative
      pressure drain will be inserted below the lower flap directing to the axilla in the single
      drain group or two similar drains will be inserted into the axilla and below the lower flap
      in the double drains group. Drains will be removed if the output is less than 30 ml. Seroma
      is defined as fluid accumulation below the flaps and will be examined daily after the
      operation. One day after removal of the drains seroma under the flaps and in the axilla will
      be examined by ultrasonography. Age, body mass index smoking history, coexisting diseases of
      the patients duration of the hospital stay, duration of the drains in place, total drain
      output in the first three days after the operation and the need and frequency of aspirations
      due to seroma formation will be recorded. Patient comfort was measured with a comfort scale
      between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep
      disturbances caused by the drains, The duration of the longer staying drain in the double
      drain group will be recorded for the duration of the drain in place parameter.
Background: Seroma is one of the most common complications after mastectomies. Seroma
      formation results in delays in wound healing, incisional dehiscence, infections and long
      hospital stay. Although there are studies proving that drains do not prevent seroma
      formation, the use of drains for that purpose is still very common. Decreasing the number of
      drains used after mastectomies has been shown to decrease patients' discomfort and duration
      of hospital stay without increasing seroma formation.

      Objective: To investigate the effects of single versus double drains on patient comfort and
      seroma formation after modified radical mastectomy (MRM) Material and Method: Sixty patients
      undergoing MRM at Diskapi Yildirim Beyazit Training and Research Hospital will be randomised
      into single versus double drains groups. A negative pressure drain will be inserted below the
      lower flap directing to the axilla in the single drain group or two similar drains will be
      inserted into the axilla and below the lower flap in the double drains group. Drains will be
      removed if the output is less than 30 ml. Seroma is defined as fluid accumulation below the
      flaps and will be examined daily after the operation. One day after removal of the drains
      seroma under the flaps and in the axilla will be examined by ultrasonography. Age, body mass
      index smoking history, coexisting diseases of the patients duration of the hospital stay,
      duration of the drains in place, total drain output in the first three days after the
      operation and the need and frequency of aspirations due to seroma formation will be recorded.
      Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain,
      pain caused by the drains, discomfort or sleep disturbances caused by the drains, The
      duration of the longer staying drain in the double drain group will be recorded for the
      duration of the drain in place parameter. Two groups will be compared with chi-square,
      student's t-test or Mann-Whitney U test. P<0.005 will be considered as significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Patient Comfort Scale
time frame: Postoperative 5 days
description: Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).
measure: Seroma Formation
time frame: Twenty-four hours after removal of the drains up to 4 weeks
description: Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography..
measure: Length of Hospital Stay
time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
arm group label: Single drain
arm group type: Experimental
description: Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
arm group label: Double drain
arm group type: Experimental
description: Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.
Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
intervention type: Procedure
intervention name: Insertion of a single drain
description: A negative pressure drain will be inserted below the lower flap directing to the axilla.
arm group label: Single drain
intervention type: Procedure
intervention name: Insertion of double drains
description: Two drains will be inserted into the axilla and below the lower flap in the double drains group.
arm group label: Double drain
intervention type: Procedure
intervention name: Ultrasonography after removal of the drains
description: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
arm group label: Double drain
arm group label: Single drain
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Akinci M, Cetin B, Aslan S, Kulacoglu H. Factors affecting seroma formation after mastectomy with full axillary dissection. Acta Chir Belg. 2009 Jul-Aug;109(4):481-3. doi: 10.1080/00015458.2009.11680464.
PMID: 19803259
citation: Aitken DR, Minton JP. Complications associated with mastectomy. Surg Clin North Am. 1983 Dec;63(6):1331-52. doi: 10.1016/s0039-6109(16)43192-0. No abstract available.
PMID: 6359504
citation: Jain PK, Sowdi R, Anderson AD, MacFie J. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Br J Surg. 2004 Jan;91(1):54-60. doi: 10.1002/bjs.4435.
PMID: 14716794
citation: Talbot ML, Magarey CJ. Reduced use of drains following axillary lymphadenectomy for breast cancer. ANZ J Surg. 2002 Jul;72(7):488-90. doi: 10.1046/j.1445-2197.2002.02456.x.
PMID: 12123509
citation: Saratzis A, Soumian S, Willetts R, Rastall S, Stonelake PS. Use of multiple drains after mastectomy is associated with more patient discomfort and longer postoperative stay. Clin Breast Cancer. 2009 Nov;9(4):243-6. doi: 10.3816/CBC.2009.n.041.
PMID: 19933080
responsible party type: Principal Investigator
investigator affiliation: Ankara Diskapi Training and Research Hospital
investigator full name: Melih Akinci
investigator title: Melih Akinci
mesh term: Breast Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 