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Recruiting NCT07063069

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

No phase Interventional Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver Surger

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Abdominal ultrasound.
Who it may be relevant to
Registry conditions: Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver Surger. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other Abdominal 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

Primary outcome measures

  • Evaluate the sensitivity and specificity of the diagnostic character of the gastric diameter ratio at Day 2 / Day 0 [Time frame: Day 2/Day 0 after surgical intervention]
Secondary outcome measures (2)
  • assess the sensitivity and specificity of the gastric diameter ratio at D2/D0 in predicting the onset of inhalation pneumonitis [Time frame: Day 2/Day 0 after surgical intervention]
  • code a computer program to automatically measure the diameter of the gastric antrum [Time frame: Day 2/Day 0 after surgical intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • University Hospital of Angers — Angers

Identifiers

NCT: NCT07063069 · 49RC24_0252 · 2025-A00733-46

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗