Abdominal Binder and Steps (ABS): A Way to Improve Ambulation Post-Laparotomy in Benign GYN Surgery
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Post-operative Milestones
- 发起方
- Icahn School of Medicine at Mount Sinai
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Daily step counts
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
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.
详细描述
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.
研究者
Charles Ascher-Walsh
Associate Professor, Department of Obstetrics, Gynecology, and Reproductive Science
Icahn School of Medicine at Mount Sinai
入排标准
入选标准
- •English-speaking
- •Patients undergoing benign hysterectomy or myomectomy via low-transverse laparotomy.
排除标准
- •ASA classification of three or higher
- •Malignancy
- •Non-English speaking
结局指标
主要结局
Daily step counts
时间窗: 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.
次要结局
- Visual analogue pain scale(24-48 hours post-operatively (the typical time from surgery to discharge))
- Narcotic utilization(24-48 hours post-operatively (the typical time from surgery to discharge))
- Number of participants who thinks there was a benefit(Two weeks (at time of post-operative visit))
- Time to Ambulation(Within 24 hours (post-operative day one))