<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/NCT04414384</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 19-2072</org_study_id>
    <nct_id>NCT04414384</nct_id>
  </id_info>
  <brief_title>Abdominal Binder and Steps Trial</brief_title>
  <acronym>ABS</acronym>
  <official_title>Abdominal Binder and Steps (ABS): A Way to Improve Ambulation Post-Laparotomy in Benign GYN Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</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>
      Large lower abdominal incisions are still used in many types of common gynecologic surgeries.&#xD;
      Patients may experience pain and restrictions to ambulation because of this, which can make&#xD;
      healing after surgery harder and more complicated. Abdominal binders, through their added&#xD;
      abdominal support, may provide a low cost intervention to help people heal. The study team&#xD;
      aims to investigate the effects of abdominal binders on walking in the post- gynecologic&#xD;
      surgery period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparotomy is a commonly utilized modality for abdominal entry in benign gynecologic surgery&#xD;
      despite preference for minimally invasive techniques when surgically feasible. As with other&#xD;
      major abdominal surgeries, patients may experience pain and restrictions to ambulation&#xD;
      related to the abdominal incision that complicate the postoperative period. Abdominal&#xD;
      binders, through their added abdominal support, may provide a low cost, noninvasive&#xD;
      intervention to enhance this vital recovery period. Though the use of abdominal binders have&#xD;
      been studied extensively in the postcesarean section patient, no report to date exists&#xD;
      assessing the effects on abdominal binders in the postoperative course of benign gynecologic&#xD;
      surgeries. The study team aims to investigate the effects of abdominal binders on ambulation&#xD;
      in the postoperative period after laparotomy for benign gynecologic surgery. The primary&#xD;
      outcome is quantitative ambulation via electronic step counter. Secondary outcomes include&#xD;
      time to ambulation, quantitative narcotic utilization, visual analogue pain scale, subjective&#xD;
      overall wellbeing. With 85% power the study team attempts to calculate a 1200 step difference&#xD;
      in means between abdominal binder and control groups using 67 patients per study arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 28, 2020</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</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>
    <intervention_model_description>Patients are randomized to either the investigational group (abdominal binder) or control group (no abdominal binder). Those two groups are then both given step counters and their steps are recorded over a two week period.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Daily step counts</measure>
    <time_frame>Two weeks (until post-operative appointment when step counter is returned)</time_frame>
    <description>Daily step counts taken via electronic step counter over the course of two weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Ambulation</measure>
    <time_frame>Within 24 hours (post-operative day one)</time_frame>
    <description>Time it takes for patient to begin ambulating post-operatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Narcotic utilization</measure>
    <time_frame>24-48 hours post-operatively (the typical time from surgery to discharge)</time_frame>
    <description>Quantitative narcotic utilization while inpatient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue pain scale</measure>
    <time_frame>24-48 hours post-operatively (the typical time from surgery to discharge)</time_frame>
    <description>Patient's average pain scale as reported to nursing via analogue pain scale. Total scale from 0-10, higher score indicates more pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who thinks there was a benefit</measure>
    <time_frame>Two weeks (at time of post-operative visit)</time_frame>
    <description>Number of participants who thinks they benefitted from wearing the abdominal binder as reported retrospectively at the two week post-operative visit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">134</enrollment>
  <condition>Post-operative Milestones</condition>
  <arm_group>
    <arm_group_label>Abdominal Binder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During this time they will wear a step counter and track their steps. This step counter will be returned at the time of their two week visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This group of patients will not wear abdominal binders, but during this time they will wear a step counter and track their steps. This step counter will be returned at the time of their two week visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Abdominal Binder</intervention_name>
    <description>Abdominal Binder placement</description>
    <arm_group_label>Abdominal Binder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Step Counter</intervention_name>
    <description>step counter to track steps</description>
    <arm_group_label>Abdominal Binder</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Patients undergoing benign hysterectomy or myomectomy via low-transverse laparotomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA classification of three or higher&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Ascher-Walsh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Charles Ascher-Walsh, MD</last_name>
    <phone>212-241-7809</phone>
    <email>charles.ascher-walsh@mssm.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Brittany Roser, MD</last_name>
    <phone>212-241-7809</phone>
    <email>brittany.roser@mountsinai.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10128</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charles Ascher-Walsh, MD</last_name>
      <phone>212-241-7809</phone>
      <email>charles.ascher-walsh@mssm.edu</email>
    </contact>
    <contact_backup>
      <last_name>Brittany Roser, MD</last_name>
      <phone>212-241-7809</phone>
      <email>brittany.roser@mountsinai.org</email>
    </contact_backup>
    <investigator>
      <last_name>Charles Ascher-Walsh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Charles Ascher-Walsh</investigator_full_name>
    <investigator_title>Associate Professor, Department of Obstetrics, Gynecology, and Reproductive Science</investigator_title>
  </responsible_party>
  <keyword>Post-operative ambulation</keyword>
  <keyword>Post-operative pain</keyword>
  <keyword>Abdominal binder</keyword>
  <keyword>Step counter</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All of the individual participant data collected during the trial, after deidentification.</ipd_description>
    <ipd_time_frame>Immediately following publication. No end date.</ipd_time_frame>
    <ipd_access_criteria>Investigators whose proposed use of the data has been approved by an independent review committee (&quot;learned intermediary&quot;) identified for this purpose. To achieve aims in the approved proposal. Email to the primary investigator with IRB-approved proposal.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04414384
org study id: GCO 19-2072
nct id: NCT04414384
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Large lower abdominal incisions are still used in many types of common gynecologic surgeries.
      Patients may experience pain and restrictions to ambulation because of this, which can make
      healing after surgery harder and more complicated. Abdominal binders, through their added
      abdominal support, may provide a low cost intervention to help people heal. The study team
      aims to investigate the effects of abdominal binders on walking in the post- gynecologic
      surgery period.
Laparotomy is a commonly utilized modality for abdominal entry in benign gynecologic surgery
      despite preference for minimally invasive techniques when surgically feasible. As with other
      major abdominal surgeries, patients may experience pain and restrictions to ambulation
      related to the abdominal incision that complicate the postoperative period. Abdominal
      binders, through their added abdominal support, may provide a low cost, noninvasive
      intervention to enhance this vital recovery period. Though the use of abdominal binders have
      been studied extensively in the postcesarean section patient, no report to date exists
      assessing the effects on abdominal binders in the postoperative course of benign gynecologic
      surgeries. The study team aims to investigate the effects of abdominal binders on ambulation
      in the postoperative period after laparotomy for benign gynecologic surgery. The primary
      outcome is quantitative ambulation via electronic step counter. Secondary outcomes include
      time to ambulation, quantitative narcotic utilization, visual analogue pain scale, subjective
      overall wellbeing. With 85% power the study team attempts to calculate a 1200 step difference
      in means between abdominal binder and control groups using 67 patients per study arm.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients are randomized to either the investigational group (abdominal binder) or control group (no abdominal binder). Those two groups are then both given step counters and their steps are recorded over a two week period.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Daily step counts
time frame: Two weeks (until post-operative appointment when step counter is returned)
description: Daily step counts taken via electronic step counter over the course of two weeks.
measure: Time to Ambulation
time frame: Within 24 hours (post-operative day one)
description: Time it takes for patient to begin ambulating post-operatively.
measure: Narcotic utilization
time frame: 24-48 hours post-operatively (the typical time from surgery to discharge)
description: Quantitative narcotic utilization while inpatient.
measure: Visual analogue pain scale
time frame: 24-48 hours post-operatively (the typical time from surgery to discharge)
description: Patient's average pain scale as reported to nursing via analogue pain scale. Total scale from 0-10, higher score indicates more pain
measure: Number of participants who thinks there was a benefit
time frame: Two weeks (at time of post-operative visit)
description: Number of participants who thinks they benefitted from wearing the abdominal binder as reported retrospectively at the two week post-operative visit.
arm group label: Abdominal Binder
arm group type: Experimental
description: During this time they will wear a step counter and track their steps. This step counter will be returned at the time of their two week visit.
arm group label: Control
arm group type: Other
description: This group of patients will not wear abdominal binders, but during this time they will wear a step counter and track their steps. This step counter will be returned at the time of their two week visit.
intervention type: Other
intervention name: Abdominal Binder
description: Abdominal Binder placement
arm group label: Abdominal Binder
intervention type: Other
intervention name: Step Counter
description: step counter to track steps
arm group label: Abdominal Binder
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Charles Ascher-Walsh, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Charles Ascher-Walsh, MD
phone: 212-241-7809
email: charles.ascher-walsh@mssm.edu
last name: Brittany Roser, MD
phone: 212-241-7809
email: brittany.roser@mountsinai.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Charles Ascher-Walsh
investigator title: Associate Professor, Department of Obstetrics, Gynecology, and Reproductive Science
sharing ipd: Yes
ipd description: All of the individual participant data collected during the trial, after deidentification.
ipd time frame: Immediately following publication. No end date.
ipd access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. To achieve aims in the approved proposal. Email to the primary investigator with IRB-approved proposal.