NCT07614919

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 22, 2026

Last Update Submit

May 22, 2026

Conditions

Keywords

FastingEndoscopy, GastrointestinalGastric EmptyingPediatricsAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Gastric Residue Severity

    Severity of endoscopically observed gastric residue during upper gastrointestinal endoscopy, categorized as none, mild, moderate, or severe according to endoscopic findings documented in medical records and endoscopy reports.

    At the time of upper gastrointestinal endoscopy

Secondary Outcomes (1)

  • Clinically Relevant Gastric Residue

    At the time of upper gastrointestinal endoscopy

Study Arms (1)

Pediatric Upper Gastrointestinal Endoscopy Cohort

Pediatric patients undergoing upper gastrointestinal endoscopy for gastrointestinal symptoms or pathology will be included in this retrospective observational cohort. Data regarding demographic characteristics, gastrointestinal symptoms, preoperative fasting duration, endoscopic findings, underlying gastrointestinal diseases, medication use, and endoscopically observed gastric residue will be retrospectively evaluated using hospital records, anesthesia records, and endoscopy reports. Gastric residue severity will be categorized as none, mild, moderate, or severe.

Procedure: Upper Gastrointestinal Endoscopy

Interventions

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.

Pediatric Upper Gastrointestinal Endoscopy Cohort

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients undergoing upper gastrointestinal endoscopy for evaluation of gastrointestinal symptoms or suspected gastrointestinal pathology at a single tertiary care center will be included in this retrospective observational study. The study population will consist of patients evaluated between January 2025 and April 2026. Data will be retrospectively obtained from hospital information systems, anesthesia records, electronic medical records, and endoscopy reports. The study will evaluate demographic characteristics, gastrointestinal symptoms, preoperative fasting duration, endoscopic findings, underlying gastrointestinal diseases, medication use, and endoscopically observed gastric residue.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Yıldırım, Bursa, 16310, Turkey (Türkiye)

Location

Related Publications (3)

  • 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: 32710649BACKGROUND
  • 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: 37926966BACKGROUND
  • 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: 39445555BACKGROUND

MeSH Terms

Conditions

Fasting

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 29, 2026

Study Start

June 1, 2026

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared because the study involves retrospective review of pediatric patient records and contains potentially sensitive clinical information.

Locations