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- Ensaio 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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Gürcan Güler
- Número de telefone: +90 541 975 0407
- E-mail: gurcanguler.45@gmail.com
Locais de estudo
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Bursa
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Yıldırım, Bursa, Turquia (Türkiye), 16310
- University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
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Contato:
- Gürcan Güler
- Número de telefone: +90 541 975 0407
- E-mail: gurcanguler.45@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Gastric Residue Severity
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Clinically Relevant Gastric Residue
Prazo: 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
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Comportamento
- Comportamento Alimentar
- Jejum
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Procedimentos cirúrgicos, operatórios
- Procedimentos cirúrgicos minimamente invasivos
- Técnicas de diagnóstico, cirúrgico
- Técnicas de diagnóstico, sistema digestivo
- Endoscopia
- Procedimentos cirúrgicos do sistema digestivo
- Endoscopia, sistema digestivo
Outros números de identificação do estudo
- 2024-TBEK 2026/05-10
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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