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

NCT06974500 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2025-05-16

No results posted yet for this study

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

Conditions

  • Postoperative Ileus
  • Colorectal Cancer Control and Prevention
  • Stoma - Ileostomy

Interventions

PROCEDURE

Daily 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.

Sponsors & Collaborators

  • Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Luis Asensio, Consultant · Hospital Universitario La Paz

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-01-01
Completion
2027-04-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06974500 on ClinicalTrials.gov