Skip to content

Evaluation of the Value of Ultrasound Measurement of Stomach Diameter in Predicting Postoperative Nausea/Vomiting

Evaluation of the Value of Ultrasound Measurement of Stomach Diameter in Predicting Postoperative Nausea/Vomiting

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07063069
Acronym
EVOL2
Enrollment
150
Registered
2025-07-14
Start date
2025-08-08
Completion date
2028-03-19
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver Surger

Brief summary

The advent of enhanced rehabilitation after surgery has helped to reduce surgical stress, thereby improving postoperative outcomes by reducing the time it takes for patients to recover their transit and autonomy. Despite this, some 10-30% of patients undergoing abdominal surgery will experience postoperative ileus or nausea/vomiting. In addition to increasing the length of hospital stay, these complications increase patient discomfort and, above all, the risk of inhalation pneumonitis. With the advent of enhanced rehabilitation, patients are receiving less drainage, particularly nasogastric drainage, which is now virtually outlawed in scheduled sub-mesocolic abdominal surgery. In a recent international multicenter study of patients undergoing colorectal surgery, the authors reported that less than 10% of patients received a nasogastric tube routinely, and that 20% received it for clinical reasons (before or after nausea/vomiting). The authors also reported an overall inhalation pneumonitis rate of 4.2%. The authors concluded from this study that nasogastric tubes should not be inserted routinely, but that delay in nasogastric tube insertion was a risk factor for pneumopathy. As the onset of postoperative pneumopathy is associated with a risk of mortality, it seems important to predict its risk of onset in order to target patients who could benefit from early nasogastric tube placement. A recent study carried out in the visceral surgery department of the CHU d'Angers evaluated the evolution of gastric distension. One of the objectives of the ancillary study was to evaluate the interest of the ratio of gastric antrum distension measurement in 2 axes (longitudinal and axial) at D2 postoperative / D preoperative. As this was an ancillary study of a preliminary study, the number of events was 12, making it impossible to assert with high power that the appearance of nausea/vomiting is linked to the ratio described above. An observational study including more patients is therefore needed to confirm this hypothesis before carrying out a randomized controlled trial.

Interventions

OTHERAbdominal ultrasound

All patients included will have an abdominal ultrasound scan to mesure anterior/posterior external diameter of gastric antrum upstream of pyloru and external diameter upper/lower of gastric antrum upstream of pylorus

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Major patient * Indication for major abdominal surgery (submesocolic, parietal, left pancreas or liver) * Patient affiliated to or benefiting from a social security scheme Non-inclusion criteria * Patient refusal to participate in study * Need for immediate post-operative ICU stay * Surgery performed as an emergency * Esophageal, gastric or cephalic pancreatic surgery * Person deprived of liberty by judicial or administrative decision * Person under compulsory psychiatric care

Exclusion criteria

* Discharge with nasogastric tube * Immediate admission to post-operative intensive care unit

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the sensitivity and specificity of the diagnostic character of the gastric diameter ratio at Day 2 / Day 0Day 2/Day 0 after surgical interventionPostoperative ileus is defined according to the Vather et al. criteria.

Secondary

MeasureTime frameDescription
assess the sensitivity and specificity of the gastric diameter ratio at D2/D0 in predicting the onset of inhalation pneumonitisDay 2/Day 0 after surgical interventionthe onset of inhalation pneumonitis, defined as a cough with varying degrees of fever secondary to surgery. Inhalation pneumonitis is clinically suspected and confirmed on imaging with a standard chest X-ray
code a computer program to automatically measure the diameter of the gastric antrumDay 2/Day 0 after surgical interventionGastric antrum diameter measurements and images

Countries

France

Contacts

CONTACTJean-Baptiste Philippe, MD
JeanBaptiste.Philippe@chu-angers.fr0241353618
CONTACTAurelien Venara, MD, PhD
auvenara@chu-angers.fr0241353618

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026