跳至主要内容
临床试验/CTRI/2024/08/073012
CTRI/2024/08/073012招募中不适用

The use of chewing gum to enhance recovery of bowel function after Spine surgery: A randomised controlled trial

Stavya Spine Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月9日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Postoperative analysis of 100 patients undergoing lumbar spine fusion at a single level in the post operative period.

研究概览

简要总结

This is a single center prospective observational study. 100 consecutive patients undergoing fusion of the lumbar spine at a single level will be recruited. They will be randomly allotted to the control or interventional group by computer generated randomization. The control group will undergo routine post operative care, while the intervention group will be given sham feeding with chewing gum. Post surgery, the patients will be evaluated immediately post operatively, at one hour post surgery, six hours post surgery, 12 hours post surgery and at twenty four hours post surgery. Relevant outcome measure data will be collected and recorded on Microsoft Excel.

研究设计

研究类型
Observational

入排标准

年龄范围
10.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 100 consecutive patients admitted at our center undergoing single level spinal fusion will be enrolled for the study.

排除标准

  • Patients with Cauda Equina Syndrome Patients with pre-operative constipation Patients who underwent previous bowel surgery.

结局指标

主要结局

Postoperative analysis of 100 patients undergoing lumbar spine fusion at a single level in the post operative period.

时间窗: No further follow up visit is required.

次要结局

  • Statistical & accessory noninvasive information which will be collected as found additionally of importance.(No further follow up is required.)

研究者

发起方
Stavya Spine Hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Bharat R Dave

Stavya Spine Hospital And Research Institute

研究点 (1)

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