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临床试验/NCT04414384
NCT04414384已完成不适用

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

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2020年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
1
主要终点
Daily step counts

研究概览

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charles Ascher-Walsh

Associate Professor, Department of Obstetrics, Gynecology, and Reproductive Science

Icahn School of Medicine at Mount Sinai

研究点 (1)

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