Does Chewing Gum Affect the Incidence of Post-operative Ileus in Patients Undergoing Spine Surgery?
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- first flatus time
研究概览
简要总结
The purpose of this study is to determine whether chewing gum post-operatively decreases the time to first flatus or defecation in patients undergoing spine surgery as a indirect indicator of post-operative ileus.
详细描述
The patients undergoing spine surgery are at risk of developing post-operative ileus, which will lengthen the hospital stay and cause gastrointestinal distress in patients. Post-operative sham feeding in form of chewing a gum seems to increase the functionality of gastro-intestinal tract earlier in patients who have undergone gastro-intestinal and gynecological surgeries.
This study will recruit patients undergoing spine surgery at the investigators medical center and allocate them randomly into two equal groups. Patients in one group will be asked to chew gum after surgery and the other group will not be offered anything on chew on. Both groups will be kept nothing per os (NPO) otherwise till the first bowel movement. The first post-operative flatus and defecation time will be recorded as primary measures and other main outcomes will include first post-operative meal, length of stay and presence of ileus. The descriptive parameters of the two groups will also be recorded as related to relevant medical history, surgery, and post-operative care, to adjust for its effect on outcome measures.
This study will identify any beneficial effect that chewing gum will have on post-operative ileus development and might be helpful in establishing better post-operative care protocols in patients undergoing spine surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 13 years of age or older
- •Patients who will undergo spine decompression, laminectomy (cervical, lumbar and/or thoracic), discectomy, foraminotomy, or corpectomy, with or without arthrodesis, with or without instrumentation.
排除标准
- •Less than 13 years of age
- •Patients who have undergone with abdominal surgery within the last month
- •Patients with inability or problems with chewing and/or dysphagia
- •Patients who are expected to be kept intubated after surgery
- •Patients who are allergic to any chewing gum component
结局指标
主要结局
first flatus time
时间窗: post-operative hospital stay till discharge (up to 5 days)
time of passing the first flatus after surgery; monitored for first flatus for up to 5 days after surgery.
first defecation time
时间窗: post-operative hospital stay till discharge (up to 5 days)
time of passing the first defecation after surgery, monitored for first defecation for up to 5 days after surgery.
次要结局
- Meal time(post-operative hospital stay till discharge (up to 5 days))
- LOS(hospital stay (average of 5 days))
- post-operative ileus(post-operative hospital stay till discharge (up to 5 days))
研究者
Dr. Abdel Majid Sheikh Taha
Clinical Instructor of Orthopedic Surgery
American University of Beirut Medical Center