跳至主要内容
临床试验/NCT01579175
NCT01579175已完成1 期

The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery.

Johns Hopkins University4 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
294
试验地点
4
主要终点
Time to flatus

研究概览

简要总结

The investigators are randomizing patients to receive chewing gum (Extra Sugar Free, Spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative care. The investigators then have them fill out a survey in house and 1 week after their surgery that record time to first flatus, hunger, toleration of clear liquids and food and some information about pain, satisfaction, and quality of life. The investigators contact them via phone and email a maximum of three times in order to collect this information. 30 days postoperatively the investigators also contact them and perform a chart review for any postoperative complications.

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
None

入排标准

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

入选标准

  • 18 years or older
  • Undergoing benign gynecologic surgery via an exploratory laparotomy
  • Capable of giving consent

排除标准

  • Oromaxillary or mental disturbances that would make chewing gum dangerous with regards to mastication or aspiration
  • Intubated or unconscious when leaving the OR
  • Bowel resection performed at the time of surgery
  • Active bowel disease (IBD, appendicitis, etc)
  • Gynecologic malignancy

结局指标

主要结局

Time to flatus

时间窗: 30 days

次要结局

  • Postoperative ileus(30 days)
  • time to discharge(30 days)
  • time to toleration of diet(30 days)
  • patient satisfaction(30 days)

研究者

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

Catherine Sewell

Principal Investigator

Johns Hopkins University

研究点 (4)

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