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Not yet recruitingNCT07916077PGV-PONVUpdated Nov 4, 2026

Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases

An observational study in Postoperative Nausea and Vomiting, sponsored by Ankara Etlik City Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Ankara Etlik City Hospital · Observational

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
118
Ages
3 Years to 12 Years
Sex
All
01

Study summary

Postoperative nausea and vomiting (PONV) is one of the common complications in the pediatric patient group. Laparoscopic surgeries further increase the risk of postoperative nausea and vomiting due to increased intra-abdominal pressure and carbon dioxide use. In this study, gastric volume will be measured by ultrasonography in the preoperative period in order to investigate whether the fullness of the stomach and gastric volume are related to the predictability of postoperative nausea and vomiting. This study may contribute to clinical practices in predicting postoperative nausea and vomiting and developing preventive strategies in children aged 3-12 years undergoing laparoscopic appendectomy.

Read the detailed description

Postoperative nausea and vomiting is one of the complications frequently encountered in pediatric patients that seriously affects patient comfort. In the literature, the incidence of postoperative nausea and vomiting in the pediatric population is reported to be between 20-50%. This situation reduces patient satisfaction and prolongs discharge times.

Aspiration of stomach contents into the lungs, although its frequency varies in children, is seen between 0.02-0.1% in elective surgeries and can result in severe situations such as the need for mechanical ventilation and hypoxia. Although many factors have been investigated to evaluate the risk of aspiration and predict postoperative nausea and vomiting, the role of gastric volume, which is a physiological parameter, in this regard has not been sufficiently elucidated. A limited number of studies in adults have found a significant relationship between preoperative increased stomach volume and postoperative nausea and vomiting. However, there is not enough data examining this relationship in the pediatric age group. This study aims to contribute to the literature, to determine patients at risk of postoperative nausea and vomiting by measuring preoperative stomach volumes, and to develop preventive strategies. The case group in this study; There will be ASA I, II, III children between the ages of 3-12 who will undergo laparoscopic appendectomy surgery performed by the Pediatric Surgery unit in the Pediatric Operating Room. As a result of the power analysis performed using the G*Power 3.1.9.7 program, a total of at least 118 samples was found to be sufficient with 95% power and 5% margin of error (n1=59- n2=59). The study included the pediatric age group. For this reason, informed consent will be obtained from the family or legal representatives and verbal information will be given to the children appropriate to their age. Patients' age, gender, comorbidities, regular medications, height, weight, fasting period before anesthesia, history of motion sickness Patients will be evaluated in terms of nausea and vomiting, including ASA score, preoperative gastric volume, intraoperative heart rate every 15 minutes, blood pressure, saturation, end-tidal carbon dioxide value, intra-abdominal pressure value applied during laparoscopy, in the postoperative recovery room (0th hour), 6th and 24th hours. The identity information of the participants in this research will not be included in the report, thesis or scientific publication. All individuals will be identified anonymously in the study and each participant will be assigned a code number. History of previous gastrointestinal surgery, any history of gastrointestinal system disease, those with developmental or neurological disorders, those with a history of motion sickness or postoperative nausea and vomiting, those with preoperative antiemetic use, and those whose families do not give consent will not be included in the study.

02

Conditions studied

  • Postoperative Nausea and Vomiting

Keywords

  • Preoperative gastric volume
  • Gastric ultrasonography
  • Pediatric anesthesia
  • Laparoscopic appendectomy
  • Postoperative nausea and vomiting
03

In context

Postoperative Nausea and Vomiting

631 studies on the registry are indexed under Postoperative Nausea and Vomiting; 114 are open to participants now.

This study's planned enrollment of 118 is below the median of 193 across 89 observational studies indexed under Postoperative Nausea and Vomiting.

Browse Postoperative Nausea and Vomiting studies →

Lead sponsor

Ankara Etlik City Hospital is the lead sponsor of 174 studies on the registry; 75 are open to participants now.

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

04

Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children aged 3-12 years with American Society of Anesthesiologists (ASA) physical status I-III who undergo laparoscopic appendectomy at Etlik City Hospital

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

  • Children scheduled to undergo laparoscopic appendectomy
  • Age 3-12 years
  • ASA physical status I-III

Exclusion criteria

Exclusion Criteria:

  • Previous gastrointestinal surgery
  • History of any gastrointestinal disease
  • History of motion sickness or postoperative nausea and vomiting
  • Use of medication with antiemetic effects
  • Developmental or neurological disorders
  • Parent or legal guradian unwilling to provide informed consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
118 participants (estimated)
Patient registry
No

Groups and cohorts

  • PONV Group

    Children aged 3-12 years with ASA I-III status undergoing laparoscopic appendectomy who develop postoperative nausea and vomiting during the first 24 hours after surgery. Assessments will be performed at 0, 6 and 24 hours postoperatively. Preoperative gastric volume will be estimated using ultrasonography.

  • Non-PONV Group

    Children aged 3-12 years with ASA I-III status undergoing laparoscopic appendectomy who do not develop postoperative nausea and vomiting during the first 24 hours after surgery. Assessments will be performed at 0, 6 and 24 hours postoperatively. Preoperative gastric volume will be estimated using ultrasonography.

06

What researchers measure

Primary outcomes

  1. Presence of postoperative nausea and/or vomiting within 24 hours after surgery

    Presence of postoperative nausea and/or vomiting within 24 hours after surgery. Nausea will be assessed using child or parent reports. Vomiting will be defined as the observed expulsion of gastric contents.

    Time frame: From the end of the surgery through 24 hours postoperatively.

Secondary outcomes

  1. Preoperative gastric volume

    The relationship of the following variables with postoperative nausea and vomiting (PONV) was examined: gastric volume (ml) measured via preoperative ultrasonography; gastric volume normalized per kilogram of body weight (ml/kg); the frequency of nausea and vomiting episodes in patients who developed PONV; the need for antiemetic administration due to PONV; the qualitative assessment of preoperative gastric content (empty, liquid, or solid); the duration and feasibility of measuring gastric volume using ultrasonography; as well as the duration of anesthesia, duration of surgery, dosage of opioids administered, age, and gender.

    Time frame: Preoperative measurement; PONV status determined during the first 24 hours after surgery.

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07916077
Responsible party
Bikem KÖSEM (MD, Ankara Etlik City Hospital) — Principal investigator
First posted
Nov 4, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Apr 15, 2027 (estimated)
Completion
May 15, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Bikem Kösem
Contact
bkosem95@gmail.com
905380364066

Oversight

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

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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