RecruitingNCT06974500

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


Sponsor

Hospital Universitario La Paz

Enrollment

68 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a pre-surgery bowel preparation program — where patients with an ileostomy (a surgically created opening in the abdomen for waste elimination) regularly flush their remaining intestine with fluids — to help prepare the bowel and reduce complications before the ileostomy is surgically closed. **You may be eligible if...** - You are 18 or older and have an ileostomy for any reason - Your surgeon has recommended bowel reconstruction (closing the ileostomy) - You are willing to complete at least two weeks of the preparation program before surgery **You may NOT be eligible if...** - You do not want to undergo bowel reconstruction - You cannot complete the preparation program before surgery - You have specific medical conditions that make the preparation unsafe (as determined by your doctor) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Participants in the intervention group will undergo daily stimulation of the efferent limb for a minimum of two weeks prior to ileostomy closure. The procedure involves the instillation of a solution composed of saline and a thickening agent through the efferent limb of the ileostomy via the inactive orifice. This is performed by the patient at home following specific training and instructions provided during a preoperative consultation. The stimulation begins the day after the pre-anaesthesia consultation and is carried out once per day. Patients are supported with a structured follow-up, including one physical consultation in the stoma clinic, telephone contact with the research team every 48 hours, and access to an email address for queries. The objective of the intervention is to recondition the excluded colon before the restoration of intestinal continuity in order to reduce postoperative complications.


Locations(1)

Hospital Universitario La Paz

Madrid, Spain

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NCT06974500


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