Randomized Controlled Trial of Rib Raising as Early Treatment for Post-operative Ileus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Length of Stay
研究概览
简要总结
We are conducting a randomized controlled trial the use of rib raising for post-operative ileus. Rib raising is an osteopathic manipulative technique (OMT). We will recruit all patients undergoing major abdominal surgery and once they have been enrolled, we will randomize them to receive daily rib raising or a control technique where we place hands on the back but do not apply any pressure. In preliminary studies, Rib raising has been shown to reduce post-operative ileus and hospital length of stay by up to 50%.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major abdominal surgery (laparotomy, laparoscopy excluding simple laparoscopic appendectomy or laparoscopic cholecystectomy)
排除标准
- •Open abdomen for >72 hours
- •Prior history of major post-operative complications
- •Intolerance to anesthesia
- •Co-morbidities including osteoporosis and osteopenia
- •Spine or rib fractures
- •Pregnancy
- •Prisoners
- •History of osteopathic manipulation
- •Recruitment delayed beyond 48 hours
- •Surgeon requested exclusion
研究组 & 干预措施
Rib-raising Intervention
We will do daily rib raising and lumbar release from the 5th thoracic vertebra to the 2nd lumbar vertebra for 2 minutes per side for rib raising and 2 minutes for lumbar release.
干预措施: Rib raising and lumbar release (Procedure)
Sham Intervention
We will do daily sham intervention from the 5th thoracic vertebra to the 2nd lumbar vertebra where we place our hands under the ribs for 2 minutes per side and under the lumbar area for 2 minutes without applying any pressure (or applying pressure into the bed).
干预措施: Sham procedure (Procedure)
结局指标
主要结局
Length of Stay
时间窗: 0-14 days
次要结局
- Time to first meal(0-14 days)
- Time to first flatus(0-14 days)
- Nausea/vomiting postop(0-14 days)
- Need for nasogastric tube postop(0-14 days)
- Time to first bowel movement(0-14 days)
研究者
Nina Elizabeth Glass, MD
Assistant Professor
Rutgers, The State University of New Jersey