Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitario La Paz
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Daily efferent limb stimulation for at least two weeks prior to surgery using saline solution and a thickering agent
Treatment groups
68 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov