Abdominal Binder and Steps Trial

NCT ID: NCT04414384

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-28
• Study Completion Date: 2023-06-01

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.

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.

Conditions

Post-operative Milestones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Abdominal Binder

Intervention Type: OTHER

Abdominal Binder placement

Step Counter

Intervention Type: OTHER

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.

Group Type: OTHER

Step Counter

Intervention Type: OTHER

step counter to track steps

Interventions

Abdominal Binder

Abdominal Binder placement

Intervention Type: OTHER

Step Counter

step counter to track steps

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Charles Ascher-Walsh

Associate Professor, Department of Obstetrics, Gynecology, and Reproductive Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles Ascher-Walsh, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Hospital

New York, New York, United States

Countries

United States

Other Identifiers

GCO 19-2072

Identifier Type: -

Identifier Source: org_study_id