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临床试验/NCT01879605
NCT01879605已完成4 期

Preoperative Bowel Preparation Versus no Preparation Before Spinal Surgery: a Randomised Clinical Trial

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2007年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Defecation within 72 hours postoperatively

研究概览

简要总结

This study investigated the effect of preoperative bowel preparations for patients undergoing spinal fusion surgery.

详细描述

This was a randomised clinical trial with one control group and two treatment groups.

Forty-five elective spinal fusion patients were randomised into three groups who received preoperative treatment with either enema of sorbitol and docusat natrium, Bisacodyl suppository or no bowel preparation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing spinal fusion surgery
  • Age 15 years or older
  • The patients had to understand oral and written Norwegian.
  • Postoperative pain management via epidural catheter should have been planned.

排除标准

  • Constipation
  • Regularly use of enema

研究组 & 干预措施

Enema

Experimental

Docusate natrium and sorbitol, 240 ml enema, the evening before surgery

干预措施: Docusate natrium and sorbitol (Drug)

Suppository

Active Comparator

Bisacodyl, suppository 10 mg, the evening before surgery.

干预措施: Bisacodyl (Drug)

结局指标

主要结局

Defecation within 72 hours postoperatively

时间窗: The study's outcome measures were recorded every evening between 17.00 and 21.00 hours

次要结局

  • Postoperative constipation(The study's outcome measures were recorded every evening between 17.00 and 21.00 hours)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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