NCT06974500 Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital
| NCT ID | NCT06974500 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitario La Paz |
| Condition | Postoperative Ileus |
| Study Type | OBSERVATIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 68 participants in total. It began in 2025-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Luis Asensio, Consultant
PRINCIPAL INVESTIGATOR
Hospital Universitario La Paz
Frequently Asked Questions
Who can join the NCT06974500 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postoperative Ileus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06974500 currently recruiting?
Yes, NCT06974500 is actively recruiting participants. Contact the research team at lasensio@salud.madrid.org for enrollment information.
Where is the NCT06974500 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06974500 clinical trial?
NCT06974500 is sponsored by Hospital Universitario La Paz. The principal investigator is Luis Asensio, Consultant at Hospital Universitario La Paz. The trial plans to enroll 68 participants.