Abdominal Binder and Steps Trial (ABS)

Mount Sinai Health System

Status: Completed

Conditions: Post-operative Milestones

Treatments: Other: Abdominal Binder; Other: Step Counter

Study type: Interventional

Funder types: Other

Identifiers

NCT04414384

GCO 19-2072

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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85 participants in 2 patient groups

Abdominal Binder

Experimental group

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.

Treatment:

Other: Step Counter

Other: Abdominal Binder

Control

Other group

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.

Treatment:

Other: Step Counter