<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/NCT03818633</url>
  </required_header>
  <id_info>
    <org_study_id>OBG-2560-05147</org_study_id>
    <nct_id>NCT03818633</nct_id>
  </id_info>
  <brief_title>Elastic Abdominal Binder Following Gynecologic Cancer Surgery</brief_title>
  <official_title>Effect of Elastic Abdominal Binder on Pain and Functional Recovery Following Gynecologic Cancer Surgery: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiang Mai University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chiang Mai University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgery is the primary treatment for gynecologic malignancies. The surgical approach provides&#xD;
      opportunities for removal of the affected organs and complete assessment of extent of cancer&#xD;
      spread. However, the procedures are often associated with significant morbidity. This is&#xD;
      especially true with open laparotomy, the most frequently employed approach in developing&#xD;
      countries. Delayed functional recovery influenced by pain and immobilization are important&#xD;
      contributing factors for increased morbidity. Elastic abdominal binder, a wide elastic belt&#xD;
      that is wore around the patient's abdomen to support surgical incision after surgery, has&#xD;
      been employed by clinicians for pain relief, wound complications prevention, improved&#xD;
      pulmonary function, and stabilization. Benefits of the abdominal binder use in this patient&#xD;
      population have not been properly examined.&#xD;
&#xD;
      The aim of this study is to examine the effect of postoperative elastic abdominal binder use&#xD;
      on recovery by comparing pain scores and mobility function (through the 6-minute walk test&#xD;
      [6MWT]) in postoperative gynecologic cancer patients who use versus do not use the elastic&#xD;
      abdominal binder to support incisional site.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 24, 2018</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Daily average postoperative pain scores</measure>
    <time_frame>An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation</time_frame>
    <description>The participants are asked to rate postoperative pain according to 10-cm visual analog scales from '0' (no pain) to '10' (worst possible pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six-minute walk test score change from baseline</measure>
    <time_frame>One day before operation and postoperative day 3</time_frame>
    <description>Six-minute walk test (6MWT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life: EuroQol Group's ED-5D-5L questionnaire</measure>
    <time_frame>In the morning of postoperative day 3</time_frame>
    <description>The EuroQol Group's ED-5D-5L questionnaire is employed. The health dimensions assessed include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, the participants are asked to indicate their health state related to that dimension as no problems (score '1'), slight problems (score '2'), moderate problems (score '3'), severe problems (score '4'), and extreme problems (score '5'). For this study, a score of 1-2 is considered &quot;normal&quot; while a scores of 3-5 is regarded as &quot;problem&quot;. In addition, the participants are asked to rate their overall health status according to a visual analog scale EQ VAS with '0' corresponding to &quot;the worst health imaginable&quot; and '100' indicating &quot;the best health imaginable&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of postoperative complications</measure>
    <time_frame>In the morning, up to 7 days postoperation</time_frame>
    <description>The complications of interest include febrile morbidity, wound complication, bowel ileus</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Gynecologic Cancer</condition>
  <arm_group>
    <arm_group_label>Elastic abdominal binder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No binder</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Elastic abdominal binder</intervention_name>
    <description>Each woman in the intervention group is fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder is placed snuggly tight (keeping in mind patient's comfort) on top of the hospital gown with the incision positioned at the middle part of the binder. The patients are encouraged to wear binders at all time. However, periods of break from wearing the binder are allowed at their convenience.</description>
    <arm_group_label>Elastic abdominal binder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women, diagnosed with gynecologic malignancies (carcinoma of the cervix, endometrium,&#xD;
             and ovary), undergoing open abdominal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intraoperative accidental injury to urinary or gastrointestinal organs&#xD;
&#xD;
          -  Postoperative admission to intensive care unit (ICU)&#xD;
&#xD;
          -  Postoperative intraperitoneal drain placement&#xD;
&#xD;
          -  Unable to understand and follow oral/written instructions&#xD;
&#xD;
          -  Severe neuromuscular or circulatory disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kittipat Charoenkwan, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chiang Mai University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kittipat Charoenkwan</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>February 3, 2020</last_update_submitted>
  <last_update_submitted_qc>February 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chiang Mai University</investigator_affiliation>
    <investigator_full_name>Kittipat Charoenkwan, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03818633
org study id: OBG-2560-05147
nct id: NCT03818633
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgery is the primary treatment for gynecologic malignancies. The surgical approach provides
      opportunities for removal of the affected organs and complete assessment of extent of cancer
      spread. However, the procedures are often associated with significant morbidity. This is
      especially true with open laparotomy, the most frequently employed approach in developing
      countries. Delayed functional recovery influenced by pain and immobilization are important
      contributing factors for increased morbidity. Elastic abdominal binder, a wide elastic belt
      that is wore around the patient's abdomen to support surgical incision after surgery, has
      been employed by clinicians for pain relief, wound complications prevention, improved
      pulmonary function, and stabilization. Benefits of the abdominal binder use in this patient
      population have not been properly examined.

      The aim of this study is to examine the effect of postoperative elastic abdominal binder use
      on recovery by comparing pain scores and mobility function (through the 6-minute walk test
      [6MWT]) in postoperative gynecologic cancer patients who use versus do not use the elastic
      abdominal binder to support incisional site.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Daily average postoperative pain scores
time frame: An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation
description: The participants are asked to rate postoperative pain according to 10-cm visual analog scales from '0' (no pain) to '10' (worst possible pain).
measure: Six-minute walk test score change from baseline
time frame: One day before operation and postoperative day 3
description: Six-minute walk test (6MWT)
measure: Quality of life: EuroQol Group's ED-5D-5L questionnaire
time frame: In the morning of postoperative day 3
description: The EuroQol Group's ED-5D-5L questionnaire is employed. The health dimensions assessed include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, the participants are asked to indicate their health state related to that dimension as no problems (score '1'), slight problems (score '2'), moderate problems (score '3'), severe problems (score '4'), and extreme problems (score '5'). For this study, a score of 1-2 is considered "normal" while a scores of 3-5 is regarded as "problem". In addition, the participants are asked to rate their overall health status according to a visual analog scale EQ VAS with '0' corresponding to "the worst health imaginable" and '100' indicating "the best health imaginable".
measure: Rate of postoperative complications
time frame: In the morning, up to 7 days postoperation
description: The complications of interest include febrile morbidity, wound complication, bowel ileus
arm group label: Elastic abdominal binder
arm group type: Experimental
arm group label: No binder
arm group type: No Intervention
intervention type: Device
intervention name: Elastic abdominal binder
description: Each woman in the intervention group is fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder is placed snuggly tight (keeping in mind patient's comfort) on top of the hospital gown with the incision positioned at the middle part of the binder. The patients are encouraged to wear binders at all time. However, periods of break from wearing the binder are allowed at their convenience.
arm group label: Elastic abdominal binder
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Kittipat Charoenkwan, MD, MSc
role: Principal Investigator
affiliation: Chiang Mai University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Chiang Mai University
investigator full name: Kittipat Charoenkwan, MD
investigator title: Associate Professor