- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07614919
Preoperative Fasting Duration and Gastric Residue in Pediatric Upper Gastrointestinal Endoscopy
Evaluation of Preoperative Fasting Duration and Gastric Residue in Children Undergoing Upper Gastrointestinal Endoscopy for Gastrointestinal Symptoms or Pathology
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gürcan Güler
- Número de teléfono: +90 541 975 0407
- Correo electrónico: gurcanguler.45@gmail.com
Ubicaciones de estudio
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Bursa
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Yıldırım, Bursa, Turquía (Türkiye), 16310
- University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
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Contacto:
- Gürcan Güler
- Número de teléfono: +90 541 975 0407
- Correo electrónico: gurcanguler.45@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gastric Residue Severity
Periodo de tiempo: At the time of upper gastrointestinal endoscopy
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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.
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At the time of upper gastrointestinal endoscopy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinically Relevant Gastric Residue
Periodo de tiempo: At the time of upper gastrointestinal endoscopy
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Presence of clinically relevant gastric residue during upper gastrointestinal endoscopy, defined as moderate or severe gastric residue based on endoscopic observation documented in medical and endoscopy records.
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At the time of upper gastrointestinal endoscopy
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Comportamiento
- Comportamiento de alimentación
- Ayuno
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Procedimientos quirúrgicos, operativo
- Procedimientos quirúrgicos mínimamente invasivos
- Técnicas de diagnóstico, quirúrgico
- Técnicas de diagnóstico, sistema digestivo
- Endoscopia
- Procedimientos quirúrgicos del sistema digestivo
- Endoscopia, sistema digestivo
Otros números de identificación del estudio
- 2024-TBEK 2026/05-10
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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