- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Gürcan Güler
- Telefonnummer: +90 541 975 0407
- E-mail: gurcanguler.45@gmail.com
Studiesteder
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-
Bursa
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Yıldırım, Bursa, Tyrkiet (Türkiye), 16310
- University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
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Kontakt:
- Gürcan Güler
- Telefonnummer: +90 541 975 0407
- E-mail: gurcanguler.45@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gastric Residue Severity
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinically Relevant Gastric Residue
Tidsramme: 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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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Opførsel
- Fodringsadfærd
- Faste
- Diagnostiske teknikker og procedurer
- Diagnose
- Kirurgiske procedurer, operative
- Minimalt invasive kirurgiske procedurer
- Diagnostiske teknikker, kirurgisk
- Diagnostiske teknikker, fordøjelsessystem
- Endoskopi
- Kirurgiske procedurer for fordøjelsessystem
- Endoskopi, fordøjelsessystem
Andre undersøgelses-id-numre
- 2024-TBEK 2026/05-10
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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