Mount Sinai Hospital
New York, 10128, United States
NCT Number: NCT04414384
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.
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Notify Me18 year–64 year
Female
Interventional
Not applicable
New York, 10128, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Abdominal Binder placement
step counter to track steps
Time frame: 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.
Time frame: Within 24 hours (post-operative day one)
Time it takes for patient to begin ambulating post-operatively.
Time frame: 24-48 hours post-operatively (the typical time from surgery to discharge)
Quantitative narcotic utilization while inpatient.
Time frame: 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
Time frame: 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.
Icahn School of Medicine at Mount Sinai
Other
Abdominal Binder and Steps (ABS): A Way to Improve Ambulation Post-Laparotomy in Benign GYN Surgery
Acronym: ABS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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