Clinical trial NCT04414384: Abdominal Binder and Steps Trial
Official title: Abdominal Binder and Steps (ABS): A Way to Improve Ambulation Post-Laparotomy in Benign GYN Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Milestones
Keywords: Post-operative ambulation
Post-operative pain
Abdominal binder
Step counter
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Daily step counts
timeFrame: Two weeks (until post-operative appointment when step counter is returned)
Secondary outcomes:
measure: Time to Ambulation
timeFrame: Within 24 hours (post-operative day one)
measure: Narcotic utilization
timeFrame: 24-48 hours post-operatively (the typical time from surgery to discharge)
measure: Visual analogue pain scale
timeFrame: 24-48 hours post-operatively (the typical time from surgery to discharge)
measure: Number of participants who thinks there was a benefit
timeFrame: Two weeks (at time of post-operative visit)
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Charles Ascher-Walsh, MD
role: PRINCIPAL_INVESTIGATOR
References: