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NCT Number: NCT07063069

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Angers

Angers, France

Location status: Recruiting

Location contact

Jean-Baptiste Philippe, MD

CONTACT

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abdominal ultrasound

Other

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 outcomes

  1. 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

    Postoperative ileus is defined according to the Vather et al. criteria.

Secondary outcomes

  1. 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

    the 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

  2. code a computer program to automatically measure the diameter of the gastric antrum

    Time frame: Day 2/Day 0 after surgical intervention

    Gastric antrum diameter measurements and images

Study contacts

Contact information is provided by the study sponsor or research team.

Aurelien Venara, MD, PhD

CONTACT

[email protected]

0241353618 ext. +33

Jean-Baptiste Philippe, MD

CONTACT

[email protected]

0241353618 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: EVOL2

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 14, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.