Abdominal Binder and Steps Trial (ABS)

Abdominal Binder and Steps (ABS): A Way to Improve Ambulation Post-Laparotomy in Benign GYN Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Post-operative Milestones
• Intervention / Treatment: Other: Abdominal Binder; Other: Step Counter

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.

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charles Ascher-Walsh, MD; Phone Number: 212-241-7809; Email: charles.ascher-walsh@mssm.edu
• Study Contact Backup: Name: Brittany Roser, MD; Phone Number: 212-241-7809; Email: brittany.roser@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10128
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Charles Ascher-Walsh, MD; Phone Number: 212-241-7809; Email: charles.ascher-walsh@mssm.edu
      • Contact: Brittany Roser, MD; Phone Number: 212-241-7809; Email: brittany.roser@mountsinai.org
      • Principal Investigator: Charles Ascher-Walsh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily step counts	Daily step counts taken via electronic step counter over the course of two weeks.	Two weeks (until post-operative appointment when step counter is returned)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Ambulation	Time it takes for patient to begin ambulating post-operatively.	Within 24 hours (post-operative day one)
Narcotic utilization	Quantitative narcotic utilization while inpatient.	24-48 hours post-operatively (the typical time from surgery to discharge)
Visual analogue pain scale	Patient's average pain scale as reported to nursing via analogue pain scale. Total scale from 0-10, higher score indicates more pain	24-48 hours post-operatively (the typical time from surgery to discharge)
Number of participants who thinks there was a benefit	Number of participants who thinks they benefitted from wearing the abdominal binder as reported retrospectively at the two week post-operative visit.	Two weeks (at time of post-operative visit)

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Charles Ascher-Walsh, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2020
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Post-operative pain; Abdominal binder; Post-operative ambulation; Step counter
• Other Study ID Numbers: GCO 19-2072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No