Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in bowel pattern based on gum-chewing
研究概览
简要总结
Researchers are trying to identify is chewing gum improves bowel function after anterior lumbar interbody fusion
详细描述
Aims, purpose, or objectives:
- Observe changes in bowel pattern based on gum-chewing
- Examine bowel function after anterior lumbar interbody fusion
- Measure length of time to return of bowel function after anterior lumbar interbody fusion
- Compare return of bowel function in patients who chew gum and patients standardized to usual post-operative care
- Measure the hospital length of stay amongst study groups
- Measure post-operative pain amongst study groups
Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.):
One or two level anterior lumbar interbody fusions are designed to correct lumbar spondylosis and spondylolisthesis, which can cause debilitating back and leg pain. This surgery involves an anterior approach, which often requires displacement of bowel for the length of the surgery. Patients frequently have a slow return of bowel function secondary to anesthetic time, opioid use, and primarily due to the bowel displacement intraoperatively. Because this is a one or two level surgery, many patients would benefit from same-day discharge but often remain inpatient several days due to slow return of bowel function.
Gum chewing has been shown to decrease the time for return to bowel function (RBF) in colorectal and gynecology patients postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing one or two level anterior lumbar interbody fusion
- •Diagnosis of spondylosis, spondylolisthesis, revision of foraminal stenosis or neurogenic claudication
排除标准
- •Previous bowel surgery
- •Diagnosis of an inflammatory bowel disease
- •Allergy to xylitol
- •Some participants may subsequently undergo a posterior spinal fusion on the same-day of surgery. They will not be excluded, but the investigators will include this group in a different data subset.
研究组 & 干预措施
Standard Care
Standard hospital management with no deviations from usual care
Gum chewing
Chew xylitol based, peppermint flavored gum for 30 minutes every two hours during the hours of 7 am to 9 pm, for the first 24 hours after your surgery
干预措施: Chewing gum (Other)
结局指标
主要结局
Change in bowel pattern based on gum-chewing
时间窗: 24 hours after surgery
Number of hours until return of bowel sounds
次要结局
- Bowel function(Number of hours from admission to discharge up to 48 hours)
- Length of time to return of bowel function after anterior lumbar interbody fusion(Number of hours from admission to discharge up to 48 hours)
- Pain score(24 hours post-operatively)
- Total length of hospital(Number of hours from admission to discharge up to 48 hours)
研究者
Maziyar A. Kalani
Consultant Neurosurgeon
Mayo Clinic