Clinical trial NCT06974500: Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital
Official title: Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Ileus
Colorectal Cancer Control and Prevention
Stoma - Ileostomy
Keywords: Ileostomy , Stoma, Colorectal, Posoperative
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Detailed description: Implementation of a Protocol for Efferent Limb Stimulation Prior to Ileostomy Closure at Hospital Universitario La Paz

The formation of stomas is a common surgical procedure, used in specific scenarios within general surgery, particularly in colorectal and emergency settings. While the creation of a stoma is often life-saving, the diversion of intestinal contents carries significant pathophysiological, aesthetic, and psychological repercussions for patients. Stomas may be permanent or temporary. In cases of temporary stomas, a second surgical procedure is required to close the ileostomy and re-establish normal intestinal continuity.

Several studies, as reviewed in this work, suggest that stimulation of the efferent limb prior to ileostomy closure provides measurable benefits in terms of patients' postoperative recovery. At present, however, there is no established protocol for this intervention at Hospital Universitario La Paz. This is despite its simplicity, low cost, and minimal risk, and its potential to improve patient outcomes, reduce postoperative complications, and shorten hospital stays. Implementing such a protocol could not only enhance patient care but also represent a meaningful quality improvement for the Department of General and Digestive Surgery.

The rationale behind this study is to demonstrate the clinical advantages of efferent limb stimulation before ileostomy closure and to establish a formal protocol for its use. This protocol would apply to patients with an ileostomy, regardless of the underlying condition, who are scheduled for intestinal reconstruction at Hospital Universitario La Paz. Complications following ileostomy closure are known to be common, often leading to prolonged hospitalisation. These complications result in increased direct costs from longer admissions, as well as additional use of healthcare resources through potential reoperations or pharmacological treatments.

Given these challenges, our objective is to reduce the duration of hospital stay and the incidence of complications by introducing a preoperative intervention that is both accessible and clinically effective. Efferent limb stimulation, conducted prior to closure, may provide an opportunity to mitigate common postoperative problems and improve overall patient recovery.

Our hypothesis is that stimulation of the efferent limb in patients with an ileostomy-using saline solution and thickening agents-administered between two and four weeks before intestinal reconstruction surgery, promotes faster recovery of bowel function, reduces length of hospital stay, and decreases postoperative complications. The primary outcome of interest is the reduction in the number of inpatient days, specifically measured from surgery to discharge.

Secondary objectives include evaluating the impact of the intervention on the incidence of postoperative paralytic ileus, diarrhoea, surgical site infections, and inflammatory response as indicated by C-reactive protein (CRP) levels. Additionally, the study will assess the feasibility and adherence to the newly implemented protocol.

The study is designed as a prospective cohort study with historical controls. The study population will consist of patients over the age of 18 with an ileostomy, regardless of the underlying pathology, who are scheduled for surgical restoration of intestinal continuity. Two groups will be analysed. The case group will include prospective patients who receive daily efferent limb stimulation with saline solution and a thickening agent for at least two weeks prior to surgery. The control group will consist of retrospective data from patients who underwent ileostomy closure prior to the implementation of this protocol and did not receive any form of preoperative stimulation.

Once enrolled, patients in the intervention group will follow the usual standards of care with the addition of the efferent limb stimulation protocol. All procedures and follow-up visits will be designed to ensure patient safety and will not introduce additional clinical risk

Eligibility criteria: 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.

Primary outcomes:
measure: LOS
timeFrame: 30 days after reconstructive surgery
Secondary outcomes:
measure: Paralytic Ileus
timeFrame: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
measure: Diarrhoea
timeFrame: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
measure: ISS
timeFrame: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
measure: Protocol
timeFrame: through study completion, an average 2 years
measure: CRP
timeFrame: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
measure: PCT
timeFrame: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Luis Asensio, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.