Abdominal Binder and Steps Trial
- Conditions
- Post-operative Milestones
- Interventions
- Other: Step CounterOther: Abdominal Binder
- Registration Number
- NCT04414384
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 85
- English-speaking
- Female
- Patients undergoing benign hysterectomy or myomectomy via low-transverse laparotomy.
- ASA classification of three or higher
- Malignancy
- Non-English speaking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Step Counter 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. Abdominal Binder Step Counter 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. Abdominal Binder 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.
- Primary Outcome Measures
Name Time Method Daily step counts 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
Name Time Method Narcotic utilization 24-48 hours post-operatively (the typical time from surgery to discharge) Quantitative narcotic utilization while inpatient.
Visual analogue pain scale 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
Number of participants who thinks there was a benefit 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.
Time to Ambulation Within 24 hours (post-operative day one) Time it takes for patient to begin ambulating post-operatively.
Trial Locations
- Locations (1)
Mount Sinai Hospital
🇺🇸New York, New York, United States