NCT01389986撤回2 期
Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to first flatus
研究概览
简要总结
Following extensive abdominal surgery for the treatment of endometrial or ovarian cancer, paralytic ileus frequently develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.
The objectives of this study are to evaluate effects of adding gum chewing to the conventional postoperative feeding protocol on the return of bowel function, its related complications, and patients' satisfaction.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing staging or cytoreductive surgery for primary endometrial or ovarian cancer at Maharaj Nakorn Chiang Mai hospital
排除标准
- •Perioperative hyperalimentation
- •Recent chemotherapy (within 3 weeks before surgery)
- •Previous bowel surgery
- •Inflammatory bowel diseases
- •Previous abdominal or pelvic radiation
- •Need for immediate postoperative endotracheal intubation
- •Need for postoperative admission to intensive care unit
- •Undergoing emergency surgery with oral intake of fluid or food within 4 hours before surgery
结局指标
主要结局
Time to first flatus
时间窗: Up to 7 days after surgery
次要结局
- Incidence and severity of postoperative nausea, vomiting,and abdominal discomfort(Up to 7 days after surgery)
- Time to first regular diet(Up to 7 days after surgery)
- Time to first defecation(Up to 7 days after surgery)
- Incidence of postoperative complications(Up to 7 days after surgery)
- Postoperative analgesics requirement(Up to 7 days after surgery)
- Hospital stay(On the day of hospital discharge, an expected average of 7 days)
- Patients' satisfaction(Up to 7 days after surgery)
研究者
Kittipat Charoenkwan, MD
Associate Professor
Chiang Mai University
研究点 (2)
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