Abdominal Binder and Steps Trial

NCT04414384 | Completed

• 1 other identifier: GCO 19-2072
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Milestones

Keywords

Post-operative ambulation; Post-operative pain; Abdominal binder; Step counter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to Ambulation

  Within 24 hours (post-operative day one)

• Narcotic utilization

  24-48 hours post-operatively (the typical time from surgery to discharge)

• Visual analogue pain scale

  24-48 hours post-operatively (the typical time from surgery to discharge)

• Number of participants who thinks there was a benefit

  Two weeks (at time of post-operative visit)

Study Arms (2)

Abdominal Binder

EXPERIMENTAL

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; Other: Step Counter

Control

OTHER

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

Interventions

Abdominal Binder OTHER

Abdominal Binder placement

Abdominal Binder

Step Counter OTHER

step counter to track steps

Abdominal Binder; Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10128, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Charles Ascher-Walsh, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Obstetrics, Gynecology, and Reproductive Science

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: June 28, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)