Abdominal Binder and Steps Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Abdominal Binder and Steps (ABS): A Way to Improve Ambulation Post-Laparotomy in Benign GYN Surgery

Conditions
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Post-operative Milestones

Intervention / Treatment
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* Other: Abdominal Binder
* Other: Step Counter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal Binder<br>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<br>* Abdominal Binder placement<br>Other: Step Counter<br>* step counter to track steps<br>|
| Other: Control<br>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<br>* step counter to track steps<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Ambulation | Time it takes for patient to begin ambulating post-operatively. | Within 24 hours (post-operative day one) | 
| Narcotic utilization | Quantitative narcotic utilization while inpatient. | 24-48 hours post-operatively (the typical time from surgery to discharge) | 
| Visual analogue pain scale | Patient's average pain scale as reported to nursing via analogue pain scale. Total scale from 0-10, higher score indicates more pain | 24-48 hours post-operatively (the typical time from surgery to discharge) | 
| Number of participants who thinks there was a benefit | Number of participants who thinks they benefitted from wearing the abdominal binder as reported retrospectively at the two week post-operative visit. | Two weeks (at time of post-operative visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-operative ambulation, Post-operative pain, Abdominal binder, Step counter