Stimulation the efferent limb before loop ileostomy closure with short chain fatty acids.
Fernando Fernández López, Jaime González López, Manuel Paz Novo...
https://pubmed.ncbi.nlm.nih.gov/30337046Actively Recruiting
Age: 18Years +
All Genders
ID06974500
Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital
Led by Hospital Universitario La Paz · Updated on 2025-05-16
68
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Stoma creation is a common surgical procedure used mainly in colorectal and emergency surgeries to divert intestinal contents. Although this procedure can save lives, it often causes physical, aesthetic, and psychological impacts on patients. Temporary stomas require a second surgery to close the ileostomy and restore normal bowel function. Research suggests that stimulating the efferent limb before ileostomy closure may improve postoperative recovery, reduce complications, and shorten hospital stays. This study aims to implement and evaluate such a stimulation protocol at Hospital Universitario La Paz, where no formal protocol currently exists. The study involves two patient groups: a control group with retrospective data from those who did not receive any preoperative stimulation, and an intervention group receiving daily stimulation of the efferent limb for at least two weeks before surgery. This stimulation uses a saline solution combined with a thickening agent, applied by patients at home following training. Support includes physical consultations, telephone check-ins every 48 hours, and email access. The goal is to recondition the excluded colon to enhance recovery after ileostomy closure. Participants will be monitored from surgery until discharge, with the main outcome measuring the length of hospital stay within 30 days post-surgery. Secondary outcomes include rates of paralytic ileus, diarrhea, surgical site infections, and inflammatory markers like C-reactive protein during postoperative hospital stay. The study also assesses protocol adherence and feasibility. The total participation duration and follow-up span about two years, ensuring careful evaluation of benefits and safety of the stimulation protocol.
CONDITIONS
Brief Title
Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Able to understand the study purpose, provide informed consent, and allow use of confidential health data
- Aged 18 years or older with an ileostomy and scheduled for intestinal transit reconstruction by a general surgeon
- Willing and able to participate and comply with follow-up during the study
You will not qualify if you...
- Have an ileostomy but do not wish to undergo intestinal reconstruction
- Unable to complete at least two weeks of efferent loop stimulation before surgery
- Do not provide consent to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - At least 2 weeks prior to surgery
Participants in the intervention group perform daily efferent limb stimulation at home for at least two weeks prior to ileostomy closure surgery, supported by preoperative consultation, a physical visit to the stoma clinic, and telephone and email contact with the research team.
1 physical visit and telephone contact every 48 hours during stimulation
Surgery
Duration - Day of surgery
Participants undergo ileostomy closure surgery as scheduled to restore intestinal continuity.
1 surgical procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 15 days after surgery or until discharge
Participants are monitored postoperatively to assess recovery, incidence of complications, and length of hospital stay, with assessments continuing up to 15 days after surgery or until discharge.
Approximately daily hospital visits during postoperative stay
Trial Site Locations
Total: 1 location
1
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
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Research Team
L
Luis Dr. Asensio Gómez, Consultant
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Efferent limb stimulation prior to loop ileostomy closure: a systematic review and meta-analysis.
A J Lloyd, N P Hardy, P Jordan...
https://pubmed.ncbi.nlm.nih.gov/38095756Can physiological stimulation prior to ileostomy closure reduce postoperative ileus? A prospective multicenter pilot study.
J Ocaña, J C García-Pérez, M Labalde-Martínez...
https://pubmed.ncbi.nlm.nih.gov/35596903Bowel stimulation before loop ileostomy closure to reduce postoperative ileus: a multicenter, single-blinded, randomized controlled trial.
Richard Garfinkle, Marie Demian, Sarah Sabboobeh...
https://pubmed.ncbi.nlm.nih.gov/35984521