ClinicalTrials.gg
CompletedNCT06842602Updated Apr 15, 2025

Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients

An interventional study of gum and candy in Gastroscopy, sponsored by Bursa Yüksek İhtisas Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-15.

Sponsored by Bursa Yüksek İhtisas Education and Research Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jan 2023, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
405
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Pulmonary aspiration is a rare but serious complication that can result in 57% mortality and 14% permanent damage. Fasting rules (solid foods 6-8 hours, clear liquids 2 hours) determined by anesthesia associations are applied to prevent pulmonary aspiration by reducing gastric volume. Gastric volume (≥ 0.5 mL/kg) and pH (\<2.5) values are shown to be determinants in the occurrence of pulmonary complications .

Read the detailed description

The hypothesis of this study was that preprocedure candy and chewing gum use may have no effects on gastric residual volume and pH. For this purpose, we analyzed the gastric residual volume and gastric pH values of patients who were given gum and candy before the procedure.

02

Conditions studied

  • Gastroscopy

Keywords

  • gastric pH
  • gastric residual volume
  • gastroscopy
  • candy
  • gum
  • preoperative fasting rules
03

In context

Lead sponsor

Bursa Yüksek İhtisas Education and Research Hospital is the lead sponsor of 62 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ,
  • oriented
  • cooperative
  • scheduled for elective gastroscopy

Exclusion criteria

Exclusion Criteria:

  • is (BMI) >30 kg/m2,
  • full stomach predicted patients (obstruction, stenosis, bleeding, ascites, urgency),
  • patients with diabetes
  • patients with who underwent bowel cleansing
  • patients who did not want to give consent to participate
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
405 participants (actual)

Study arms

  • Active comparator
    Group control

    strict fasting rules

    Other: strict fasting rules

  • Active comparator
    Group gum

    chewed gum within 2 hours before the procedure

    Other: gum

  • Active comparator
    Group candy

    consumed candy within 2 hours before the procedure

    Other: candy

Interventions

  • Othergum

    chewed gum within 2 hours before the procedure

  • Othercandy

    consumed candy within 2 hours before the procedure

  • Otherstrict fasting rules

    followed strict fasting rules

06

What researchers measure

Primary outcomes

  1. Gastric volume

    No washing was performed during the insertion and advancement of the endoscope. The entire gastric volume were aspirated into a scaled container (medbar collection container). The amount of collected samples was recorded .

    Time frame: baseline

  2. Gastric pH measurements

    No washing was performed during the insertion and advancement of the endoscope. The entire gastric contents were aspirated into a scaled container (medbar collection container). The amount of collected samples was recorded and pH analysis (WTW inoLab® pH 7310 Table Type pH Meter) was performed.

    Time frame: baseline

Secondary outcomes

  1. endoscopist satisfaction

    At the end of the procedure, endoscopist satisfaction (0=unsatisfied 1=abstained 2=satisfied) and procedure difficulty (0=easy 1=normal 2=difficult)

    Time frame: baseline

  2. general procedure satisfaction

    Before discharge, general procedure satisfaction (0=unsatisfied, 1=abstained, 2=satisfied), product satisfaction (0=unsatisfied, 1=abstained, 2=satisfied), product effects (1=increase in hunger, 2=increase in thirst, 3=increase in dyspepsia, 4=abstained, 5= decrease in hunger, 6= decrease in thirst, 7= decrease in dyspepsia)

    Time frame: baseline

  3. Complication

    Time frame: Perioperative

07

Study locations

1 site
  • Mehmet Fatih Erol
    Bursa, 16400, Turkey
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in Aug 2023, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2025
First posted
Feb 24, 2025
StartActual
Jan 1, 2023
Primary completionActual
Aug 1, 2023
CompletionActual
Jan 1, 2024
Last update
Apr 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06842602
Lead sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible party
Mehmet Fatih Erol (m.d, Bursa Yüksek İhtisas Education and Research Hospital) — Principal investigator
First posted
Feb 24, 2025
Start date
Jan 1, 2023
Primary completion
Aug 1, 2023
Completion
Jan 1, 2024
Last update
Apr 15, 2025

Study contacts

Mehmet fatih erol, M.D
study director · Bursa Yuksek ıhtısas tra
Füsun gözen, M.D
study director · Bursa Yuksek Ihtısas tranin and research hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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