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
This trial does not accept healthy volunteersQualifiers
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 population
Patients over 18 years of age who, regardless of the underlying cause, have an ileostomy and a medical indication for intestinal transit reconstruction.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Daily efferent limb stimulation for at least two weeks prior to surgery using saline solution and a thickering agent
Procedure/SurgeryParticipants 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Control Arm0 interventions
Group B: Arm Cases1 intervention
Trial outcomes
Primary outcomes
1
LOS
Difference in mean number of days of hospital stay between control and case group
Time frame
30 days after reconstructive surgerySecondary outcomes
1
Paralytic Ileus
Percentage of patients diagnosed with paralytic ileus during admission in the case group compared to the control group
Time frame
Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)2
Diarrhoea
Percentage of patients diagnosed with diarrhoea during admission in the case group compared to the control group
Time frame
Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)3
ISS
Percentage of patients diagnosed with surgical wound infection 30 days after surgery in the case group compared to the control group
Time frame
Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)4
Protocol
Percentage of the number of patients included in the protocol compared to the total number of ileostomies reconstructed since the protocol was implemented
Time frame
through study completion, an average 2 yearsSponsors and contacts
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Source ClinicalTrials.gov