跳至主要内容
临床试验/NCT03424447
NCT03424447Unknown2 期

Stimulation of the Efferent Loop Before Loop Ileostomy Closure

Hospital de Basurto2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2014年11月20日最近更新:
适应症
干预措施

试验速览

阶段
2 期
发起方
入组人数
140
试验地点
2
主要终点
postoperative ileus

研究概览

简要总结

The purpose of the study is to determine the impact of the efferent loop stimulation of a loop ileostomy prior to closure on postoperative complications such as ileus and hospital stay

详细描述

Stimulation was performed 3 weeks prior to the ileostomy closure using 500 cc of a thickening substance (saline and nutritional thickener) through the efferent limb.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with loop ileostomy
  • Barium transit throught the efferent limb without leaks

排除标准

  • Chemotherapy at the moment
  • Ileostomy closure at the same admission than the ileostomy creation

研究组 & 干预措施

Non stimulated

No Intervention

Prospective data obtained from non stimulated patients

Stimulated

Experimental

Prospective data obtaied from stimulated patients

干预措施: efferent limb stimulation (Procedure)

结局指标

主要结局

postoperative ileus

时间窗: during the admission for the ileostomy closure

Need for a nasogastric tube

bowel movement

时间窗: during the admission for the ileostomy closure

day of hospital stay whe stool or flatus begins

次要结局

  • hospital stay(during the admission for the ileostomy closure)

研究者

发起方
Hospital de Basurto
申办方类型
Other
责任方
Principal Investigator
主要研究者

ALBA VÁZQUEZ-MELERO

General Surgeon

Hospital de Basurto

研究点 (2)

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