- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Gürcan Güler
- Telefonnummer: +90 541 975 0407
- E-post: gurcanguler.45@gmail.com
Studieorter
-
-
Bursa
-
Yıldırım, Bursa, Turkiet (Türkiye), 16310
- University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
-
Kontakt:
- Gürcan Güler
- Telefonnummer: +90 541 975 0407
- E-post: gurcanguler.45@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gastric Residue Severity
Tidsram: At the time of upper gastrointestinal endoscopy
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinically Relevant Gastric Residue
Tidsram: At the time of upper gastrointestinal endoscopy
|
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.
|
At the time of upper gastrointestinal endoscopy
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Beteende
- Matningsbeteende
- Fasta
- Diagnostiska tekniker och procedurer
- Diagnos
- Kirurgiska ingrepp, operativ
- Minimalt invasiva kirurgiska ingrepp
- Diagnostiska tekniker, kirurgiska
- Diagnostiska tekniker, matsmältningssystem
- Endoskopi
- Matsmältningssystemets kirurgiska procedurer
- Endoskopi, matsmältningssystem
Andra studie-ID-nummer
- 2024-TBEK 2026/05-10
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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