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

NCT06974500 | Recruiting

• 1 other identifier: PI-6255
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Ileostomy , Stoma, Colorectal, Posoperative

Outcome Measures

Primary Outcomes (1)

• LOS

  Difference in mean number of days of hospital stay between control and case group

  30 days after reconstructive surgery

Secondary Outcomes (6)

• Paralytic Ileus

  Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)

• Diarrhoea

  Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)

• ISS

  Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)

• Protocol

  through study completion, an average 2 years

• CRP

  Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)

Study Arms (2)

Control Arm

Retrospective data from patients who did not undergo pre-ileostomy closure stimulation prior to the introduction of the efferent loop stimulation protocol.

Arm Cases

Prospective patients with daily stimulation of the efferent loop at least two weeks prior to surgery with saline and thickener.

Procedure: Daily efferent limb stimulation for at least two weeks prior to surgery using saline solution and a thickering agent

Interventions

Daily efferent limb stimulation for at least two weeks prior to surgery using saline solution and a thickering agent PROCEDURE

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.

Arm Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients over 18 years of age who, regardless of the underlying cause, have an ileostomy and a medical indication for intestinal transit reconstruction.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Related Publications (4)

• Fernandez Lopez F, Gonzalez Lopez J, Paz Novo M, Ladra Gonzalez MJ, Paredes Cotore J. Stimulation the efferent limb before loop ileostomy closure with short chain fatty acids. Cir Esp (Engl Ed). 2019 Jan;97(1):59-61. doi: 10.1016/j.ciresp.2018.06.018. Epub 2018 Oct 15. No abstract available. English, Spanish.

  PMID: 30337046 BACKGROUND

• Lloyd AJ, Hardy NP, Jordan P, Ryan EJ, Whelan M, Clancy C, O'Riordan J, Kavanagh DO, Neary P, Sahebally SM. Efferent limb stimulation prior to loop ileostomy closure: a systematic review and meta-analysis. Tech Coloproctol. 2023 Dec 14;28(1):15. doi: 10.1007/s10151-023-02875-2.

  PMID: 38095756 BACKGROUND

• Ocana J, Garcia-Perez JC, Labalde-Martinez M, Rodriguez-Velasco G, Moreno I, Vivas A, Clemente-Esteban I, Ballestero A, Abadia P, Ferrero E, Fernandez-Cebrian JM, Die J. Can physiological stimulation prior to ileostomy closure reduce postoperative ileus? A prospective multicenter pilot study. Tech Coloproctol. 2022 Aug;26(8):645-653. doi: 10.1007/s10151-022-02620-1. Epub 2022 May 21.

  PMID: 35596903 BACKGROUND

• Garfinkle R, Demian M, Sabboobeh S, Moon J, Hulme-Moir M, Liberman AS, Feinberg S, Hayden DM, Chadi SA, Demyttenaere S, Samuel L, Hotakorzian N, Quintin L, Morin N, Faria J, Ghitulescu G, Vasilevsky CA, Boutros M; Bowel Stimulation Research Collaborative. Bowel stimulation before loop ileostomy closure to reduce postoperative ileus: a multicenter, single-blinded, randomized controlled trial. Surg Endosc. 2023 May;37(5):3934-3943. doi: 10.1007/s00464-022-09510-5. Epub 2022 Aug 19.

  PMID: 35984521 BACKGROUND

Study Officials

• Luis Asensio, Consultant

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Dr. Asensio Gómez, Consultant

CONTACT

+34 650675894; lasensio@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant General Surgery

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 16, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)