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Abdominal Binder and Steps Trial (ABS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04414384
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Charles Ascher-Walsh, Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-operative Milestones Other: Abdominal Binder Other: Step Counter Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Abdominal Binder and Steps (ABS): A Way to Improve Ambulation Post-Laparotomy in Benign GYN Surgery
Actual Study Start Date : June 28, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
Experimental: Abdominal Binder
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.
Other: Abdominal Binder
Abdominal Binder placement

Other: Step Counter
step counter to track steps

Control
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.
Other: Step Counter
step counter to track steps




Primary Outcome Measures :
  1. Daily step counts [ Time Frame: Two weeks (until post-operative appointment when step counter is returned) ]
    Daily step counts taken via electronic step counter over the course of two weeks.


Secondary Outcome Measures :
  1. Time to Ambulation [ Time Frame: Within 24 hours (post-operative day one) ]
    Time it takes for patient to begin ambulating post-operatively.

  2. Narcotic utilization [ Time Frame: 24-48 hours post-operatively (the typical time from surgery to discharge) ]
    Quantitative narcotic utilization while inpatient.

  3. Visual analogue pain scale [ Time Frame: 24-48 hours post-operatively (the typical time from surgery to discharge) ]
    Patient's average pain scale as reported to nursing via analogue pain scale. Total scale from 0-10, higher score indicates more pain

  4. Number of participants who thinks there was a benefit [ Time Frame: Two weeks (at time of post-operative visit) ]
    Number of participants who thinks they benefitted from wearing the abdominal binder as reported retrospectively at the two week post-operative visit.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English-speaking
  • Female
  • Patients undergoing benign hysterectomy or myomectomy via low-transverse laparotomy.

Exclusion Criteria:

  • ASA classification of three or higher
  • Malignancy
  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414384


Contacts
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Contact: Charles Ascher-Walsh, MD 212-241-7809 charles.ascher-walsh@mssm.edu
Contact: Brittany Roser, MD 212-241-7809 brittany.roser@mountsinai.org

Locations
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United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10128
Contact: Charles Ascher-Walsh, MD    212-241-7809    charles.ascher-walsh@mssm.edu   
Contact: Brittany Roser, MD    212-241-7809    brittany.roser@mountsinai.org   
Principal Investigator: Charles Ascher-Walsh, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Charles Ascher-Walsh, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Charles Ascher-Walsh, Associate Professor, Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04414384    
Other Study ID Numbers: GCO 19-2072
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Time Frame: Immediately following publication. No end date.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Charles Ascher-Walsh, Icahn School of Medicine at Mount Sinai:
Post-operative ambulation
Post-operative pain
Abdominal binder
Step counter