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Not yet recruiting NCT07614919

Preoperative Fasting Duration and Gastric Residue in Pediatric Upper Gastrointestinal Endoscopy

Observational Gastric Residue Preoperative Fasting Upper Gastrointestinal Endoscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Upper Gastrointestinal Endoscopy.
Who it may be relevant to
Registry conditions: Gastric Residue, Preoperative Fasting, Upper Gastrointestinal Endoscopy. Basic parameters: 0 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Preoperative Fasting Duration and Gastric Residue in Children Undergoing Upper Gastrointestinal Endoscopy for Gastrointestinal Symptoms or Pathology

Overview

This retrospective observational study aims to evaluate the relationship between preoperative fasting duration and gastric residue in pediatric patients undergoing upper gastrointestinal endoscopy for gastrointestinal symptoms or pathology. The study will assess the associations between gastric residue, gastrointestinal symptoms, underlying gastrointestinal diseases, and endoscopic findings. Data will be retrospectively collected from hospital records, anesthesia records, and endoscopy reports to investigate whether prolonged fasting duration reliably predicts an empty stomach in pediatric gastrointestinal patients.

Detailed description

Pulmonary aspiration is one of the most feared complications in pediatric anesthesia, and preoperative fasting is routinely used to reduce gastric content and aspiration risk. Current pediatric fasting guidelines support more liberal fasting regimens, especially for clear liquids, in order to avoid unnecessary prolonged fasting. However, prolonged fasting duration does not always guarantee an empty stomach, particularly in pediatric patients with gastrointestinal symptoms or underlying gastrointestinal pathology.

Recent studies evaluating gastric contents in children have mainly focused on gastric ultrasonography and estimated gastric volume in healthy pediatric populations. Data regarding directly observed gastric residue during upper gastrointestinal endoscopy in pediatric gastrointestinal patients remain limited.

This retrospective observational single-center study will include pediatric patients who underwent upper gastrointestinal endoscopy for gastrointestinal symptoms or pathology between January 2025 and April 2026. Data will be retrospectively obtained from hospital information systems, anesthesia records, electronic medical records, and endoscopy reports.

Demographic characteristics, gastrointestinal symptoms, underlying gastrointestinal diseases, medication use, endoscopic findings, preoperative fasting duration, and endoscopically observed gastric residue will be evaluated. Gastric residue severity will be categorized as none, mild, moderate, or severe. In addition, clinically relevant residue will be defined as moderate or severe gastric residue.

The primary objective of the study is to evaluate the relationship between preoperative fasting duration and gastric residue severity. Secondary analyses will assess factors associated with clinically relevant gastric residue, including gastrointestinal inflammatory disease and other clinical variables.

The findings of this study may contribute to a better understanding of gastric residue patterns in pediatric gastrointestinal patients and support more individualized perioperative fasting assessment approaches.

Interventions

  • Procedure Upper Gastrointestinal Endoscopy
    Upper gastrointestinal endoscopy performed for evaluation of gastrointestinal symptoms or pathology in pediatric patients. The procedure was conducted under sedation or anesthesia according to institutional clinical practice. Endoscopic findings and endoscopically observed gastric residue were retrospectively evaluated from medical records and endoscopy reports.

Primary outcome measures

  • Gastric Residue Severity [Time frame: At the time of upper gastrointestinal endoscopy]
Secondary outcome measures (1)
  • Clinically Relevant Gastric Residue [Time frame: At the time of upper gastrointestinal endoscopy]

Eligibility criteria

Inclusion criteria

  • Pediatric patients aged under 18 years
  • Patients who underwent upper gastrointestinal endoscopy for gastrointestinal symptoms or pathology
  • Patients with available hospital records, anesthesia records, and endoscopy reports
  • Patients with documented preoperative fasting duration
  • Patients with documented endoscopic assessment of gastric residue

Exclusion criteria

  • Patients aged 18 years or older
  • Patients with missing or incomplete data for key study variables
  • Patients without documented preoperative fasting duration
  • Patients without documented gastric residue assessment during endoscopy
  • Duplicate endoscopy records from the same patient, if only the first eligible procedure is included

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital — Yıldırım

Publications

  • Shava U, Srivastava A, Mathias A, Kumar N, Yachha SK, Gambhir S, Poddar U. Functional dyspepsia in children: A study of pathophysiological factors. J Gastroenterol Hepatol. 2021 Mar;36(3):680-686. doi: 10.1111/jgh.15193. Epub 2020 Aug 5. PMID 32710649
  • Santucci NR, Corsiglia J, El-Chammas K, Shumeiko O, Liu C, Kaul A. Liquid and solid gastric emptying and correlation with clinical characteristics in pediatric patients with dyspepsia. Neurogastroenterol Motil. 2024 Jan;36(1):e14701. doi: 10.1111/nmo.14701. Epub 2023 Nov 5. PMID 37926966
  • Frykholm P, Hansen TG, Engelhardt T. Preoperative fasting in children. The evolution of recommendations and guidelines, and the underlying evidence. Best Pract Res Clin Anaesthesiol. 2024 Jun;38(2):103-110. doi: 10.1016/j.bpa.2024.03.003. Epub 2024 Mar 16. PMID 39445555

Identifiers

NCT: NCT07614919 · 2024-TBEK 2026/05-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗