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临床试验/NCT02433938
NCT02433938已完成不适用

Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery

University of Florence0 个研究点目标入组 160 人开始时间: 2015年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
160
主要终点
bowel function recovery (Time to first bowel movement or flatus)

研究概览

简要总结

Aim of the study is to evaluate the role of postoperative tibial nerve stimulation in the enhancement of the recovery of bowel function and in shortening the hospital stay.

详细描述

Patients were randomized in two groups. The first group underwent a three days postoperative transcutaneous tibial nerve stimulation. The second group underwent a sham stimulation. Aim of the study is to evaluate the role of tibial nerve stimulation in the postoperative recovery after colorectal surgery.

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 (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients that underwent colorectal surgery

排除标准

  • Severe comorbidities
  • Postoperative or intraoperative complications

研究组 & 干预措施

Underwent tibial nerve stimulation

Experimental

Patients that underwent standard postoperative protocol + tibial nerve stimulation for 3 days

干预措施: Tibial nerve stimulation (Procedure)

Did not undergo tibial nerve stimulation

Sham Comparator

Patients that underwent standard postoperative protocol + sham tibial nerve stimulation (standard postoperative protocol+sham tns)

干预措施: Sham tibial nerve stimulation (Procedure)

结局指标

主要结局

bowel function recovery (Time to first bowel movement or flatus)

时间窗: 7 days

Time to first bowel movement or flatus

次要结局

  • Length of postoperative hospital stay(30 days)
  • Post-operative vomiting (episodes of vomiting)(30 days)
  • Use of NG Tubes (Nasogastric tube (re)insertions)(30 days)

研究者

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

Jacopo Martellucci

MD, PhD

University of Florence

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