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

Recruitingn/aAges 18 Years - anyAllHospital Universitario La Paz
NCT06974500 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 reduc

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📋 Eligibility rules (as published)
IInclusion Criteria: 1. Subjects must be able to understand the purpose and risks of the study, provide informed consent, and authorise the use of confidential health information. 2. 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. 3. Subjects who are able and willing to participate and to comply with follow-up for the duration of the study. Exclusion Criteria: 1. Subjects with an ileostomy who do not wish to undergo intestinal reconstruction. 2. Subjects who are unable to complete at least two weeks of efferent loop stimulation prior to reconstruction surgery. 3. Subjects who do not provide consent to participate in the study.
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What it tests

  • Daily efferent limb stimulation for at least two weeks prior to surgery using saline solution and a thickering agent
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Where

1 site
Hospital Universitario La Paz
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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