<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/NCT03820115</url>
  </required_header>
  <id_info>
    <org_study_id>OBG-2561-05421</org_study_id>
    <nct_id>NCT03820115</nct_id>
  </id_info>
  <brief_title>Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions</brief_title>
  <official_title>Effect of Elastic Abdominal Binder on Pain and Functional Recovery After Open Abdominal Surgery for Benign Gynecologic Conditions: 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 remains the backbone of modern management of benign gynecologic conditions. Some&#xD;
      common surgical procedures include hysterectomy for uterine leiomyoma or adenomyosis,&#xD;
      adnexectomy for ovarian and tubal pathology, and other conservative surgeries. These&#xD;
      procedures can be accomplished by different surgical approaches comprising abdominal,&#xD;
      vaginal, and laparoscopic routes. Although the use of vaginal and laparoscopic approach has&#xD;
      increased in recent years, the open abdominal route is still the most commonly employed&#xD;
      approach. This is especially the case in developing countries where resources to support the&#xD;
      more expensive approach such as laparoscopy are quite limited. However, the procedure can be&#xD;
      associated with significant morbidity. Delayed functional recovery influenced by pain and&#xD;
      immobilization are important contributing factors for increased morbidity. Elastic abdominal&#xD;
      binder, a wide elastic belt that is wore around the patient's abdomen to support surgical&#xD;
      incision after surgery, has been employed by clinicians for pain relief, wound complications&#xD;
      prevention, improved pulmonary function, and stabilization. Benefits of the abdominal binder&#xD;
      use in this patient 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 patients who use versus do not use the elastic abdominal&#xD;
      binder to support incisional site.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 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>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">66</enrollment>
  <condition>Gynecologic Disease</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 benign gynecologic conditions, undergoing open abdominal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Surgeries performed for cancer&#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 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genital Diseases, Female</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/NCT03820115
org study id: OBG-2561-05421
nct id: NCT03820115
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgery remains the backbone of modern management of benign gynecologic conditions. Some
      common surgical procedures include hysterectomy for uterine leiomyoma or adenomyosis,
      adnexectomy for ovarian and tubal pathology, and other conservative surgeries. These
      procedures can be accomplished by different surgical approaches comprising abdominal,
      vaginal, and laparoscopic routes. Although the use of vaginal and laparoscopic approach has
      increased in recent years, the open abdominal route is still the most commonly employed
      approach. This is especially the case in developing countries where resources to support the
      more expensive approach such as laparoscopy are quite limited. However, the procedure can be
      associated with significant morbidity. 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 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: 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
mesh term: Genital Diseases, Female