Gastric ResidueNCT07614919
Preoperative Fasting Duration and Gastric Residue in Pediatric Upper Gastrointestinal Endoscopy
An observational study of Gastric Residue and Preoperative Fasting, run by Bursa Sevket Yilmaz Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Gastric Residue, Preoperative Fasting, Upper Gastrointestinal Endoscopy
- What is being tested?
- Upper Gastrointestinal Endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Yıldırım, Bursa, 16310
Gürcan Güler, +90 541 975 0407, gurcanguler.45@gmail.com
About this study
Official title: Evaluation of Preoperative Fasting Duration and Gastric Residue in Children Undergoing Upper Gastrointestinal Endoscopy for Gastrointestinal Symptoms or Pathology
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.
Read the detailed description
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.
- Being tested
- Upper Gastrointestinal Endoscopy
- Keywords
- Fasting, Endoscopy, Gastrointestinal, Gastric Emptying, Pediatrics, Anesthesia
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Gastrointestinal EndoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Upper Gastrointestinal Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of upper gastrointestinal endoscopy
Secondary outcomes (1)
Clinically Relevant Gastric Residue
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.
Measured: At the time of upper gastrointestinal endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric ResidueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Sevket Yilmaz Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gürcan Güler, Bursa Sevket Yilmaz Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614919
- Sponsor's protocol ID
- 2024-TBEK 2026/05-10
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the study involves retrospective review of pediatric patient records and contains potentially sensitive clinical information.
Publications
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.
PubMed 32710649Santucci 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.
PubMed 37926966Frykholm 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.
PubMed 39445555
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Preoperative Fasting Duration and Gastric Residue in Children Undergoing Upper Gastrointestinal Endoscopy for Gastrointestinal Symptoms or Pathology
- ClinicalTrials.gov ID
- NCT07614919
- Acronym / sponsor ID
- 2024-TBEK 2026/05-10
- Keywords
- Fasting, Endoscopy, Gastrointestinal, Gastric Emptying, Pediatrics, Anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Bursa Sevket Yilmaz Training and Research HospitalOther government
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Upper Gastrointestinal Endoscopy Cohort | – | Procedure: Upper Gastrointestinal EndoscopyPediatric 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. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper Gastrointestinal EndoscopyUpper 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. | Procedure or surgery | Pediatric Upper Gastrointestinal Endoscopy Cohort |
Primary outcome
Gastric Residue Severity
Time frame: 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.
1 secondary outcome
Clinically Relevant Gastric Residue
Time frame: At the time of upper gastrointestinal endoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 32710649Shava 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.
- Background: PubMed 37926966Santucci 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.
- Background: PubMed 39445555Frykholm 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.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the study involves retrospective review of pediatric patient records and contains potentially sensitive clinical information.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Residue and Preoperative Fasting, run by Bursa Sevket Yilmaz Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gürcan Güler (+90 541 975 0407, gurcanguler.45@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Residue Severity (time frame: At the time of upper gastrointestinal endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07614919, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.