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临床试验/NCT06974500
NCT06974500招募中不适用

Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital

Hospital Universitario La Paz1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
68
试验地点
1
主要终点
LOS

研究概览

简要总结

Stoma creation is a common surgical procedure, employed in certain contexts within general surgery, particularly in colorectal and emergency surgery. Although stoma formation is a life-saving technique, the diversion of intestinal contents has pathophysiological, aesthetic, and psychological repercussions on patients' lives. Stomas may be either permanent or temporary. In temporary cases, a second intervention is required to perform ileostomy closure and restore normal intestinal transit.

Several studies indicate that stimulation of the efferent loop prior to ileostomy closure yields benefits in patients' postoperative outcomes. Currently, there is no established protocol for this intervention at Hospital Universitario La Paz. However, implementing such a protocol-given that it is a simple, inexpensive, and accessible intervention-could offer significant cost-effectiveness. It may reduce complications and hospital stay, improve patients' quality of life, and represent a valuable contribution to the General Surgery Departmen

详细描述

Implementation of a Protocol for Efferent Limb Stimulation Prior to Ileostomy Closure at Hospital Universitario La Paz

The formation of stomas is a common surgical procedure, used in specific scenarios within general surgery, particularly in colorectal and emergency settings. While the creation of a stoma is often life-saving, the diversion of intestinal contents carries significant pathophysiological, aesthetic, and psychological repercussions for patients. Stomas may be permanent or temporary. In cases of temporary stomas, a second surgical procedure is required to close the ileostomy and re-establish normal intestinal continuity.

Several studies, as reviewed in this work, suggest that stimulation of the efferent limb prior to ileostomy closure provides measurable benefits in terms of patients' postoperative recovery. At present, however, there is no established protocol for this intervention at Hospital Universitario La Paz. This is despite its simplicity, low cost, and minimal risk, and its potential to improve patient outcomes, reduce postoperative complications, and shorten hospital stays. Implementing such a protocol could not only enhance patient care but also represent a meaningful quality improvement for the Department of General and Digestive Surgery.

The rationale behind this study is to demonstrate the clinical advantages of efferent limb stimulation before ileostomy closure and to establish a formal protocol for its use. This protocol would apply to patients with an ileostomy, regardless of the underlying condition, who are scheduled for intestinal reconstruction at Hospital Universitario La Paz. Complications following ileostomy closure are known to be common, often leading to prolonged hospitalisation. These complications result in increased direct costs from longer admissions, as well as additional use of healthcare resources through potential reoperations or pharmacological treatments.

Given these challenges, our objective is to reduce the duration of hospital stay and the incidence of complications by introducing a preoperative intervention that is both accessible and clinically effective. Efferent limb stimulation, conducted prior to closure, may provide an opportunity to mitigate common postoperative problems and improve overall patient recovery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Subjects must be able to understand the purpose and risks of the study, provide informed consent, and authorise the use of confidential health information.
  • Patients over 18 years of age who, regardless of the underlying cause, have an ileostomy and a medical indication for intestinal transit reconstruction by a general surgeon.
  • Subjects who are able and willing to participate and to comply with follow-up for the duration of the study.

排除标准

  • Subjects with an ileostomy who do not wish to undergo intestinal reconstruction.
  • Subjects who are unable to complete at least two weeks of efferent loop stimulation prior to reconstruction surgery.
  • Subjects who do not provide consent to participate in the study.

结局指标

主要结局

LOS

时间窗: 30 days after reconstructive surgery

Difference in mean number of days of hospital stay between control and case group

次要结局

  • Paralytic Ileus(Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first))
  • Diarrhoea(Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first))
  • ISS(Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first))
  • Protocol(through study completion, an average 2 years)
  • CRP(Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first))
  • PCT(Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first))

研究者

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

Luis Asensio Gomez

Consultant General Surgery

Hospital Universitario La Paz

研究点 (1)

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