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

Colorectal Cancer Control and Prevention Stoma - Ileostomy Postoperative Ileus

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

Inclusion Criteria3

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.

Exclusion Criteria3

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.

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.