Post-operative Milestones
Conditions
Keywords
Post-operative ambulation, Post-operative pain, Abdominal binder, Step counter
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.
Interventions
OTHERAbdominal Binder
Abdominal Binder placement
OTHERStep Counter
step counter to track steps
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Ambulation | Within 24 hours (post-operative day one) | Time it takes for patient to begin ambulating post-operatively. |
| 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. |
Countries
United States
Outcome results
None listed