Clinical trial · Observational
Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Control and Prevention | — | UNRESOLVED | — |
| Postoperative Ileus | — | UNRESOLVED | — |
| Stoma - Ileostomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daily efferent limb stimulation for at least two weeks prior to surgery using saline solution and a thickering agent | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control Arm
- description
- Retrospective data from patients who did not undergo pre-ileostomy closure stimulation prior to the introduction of the efferent loop stimulation protocol.
- label
- Arm Cases
- description
- Prospective patients with daily stimulation of the efferent loop at least two weeks prior to surgery with saline and thickener.
- interventionNames
- Procedure: Daily efferent limb stimulation for at least two weeks prior to surgery using saline solution and a thickering agent
Primary outcomes (1)
- measure
- LOS
- timeFrame
- 30 days after reconstructive surgery
- description
- Difference in mean number of days of hospital stay between control and case group
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDFernandez 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
- BACKGROUNDLloyd 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
- BACKGROUNDOcana 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
- BACKGROUNDGarfinkle 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