Evaluation of the Value of Ultrasound Measurement of Stomach Diameter in Predicting Postoperative Nausea/Vomiting (EVOL2)

University Hospital, Angers

Status: Not yet enrolling

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

Treatments: Other: Abdominal ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT07063069

2025-A00733-46 (Other Identifier)

49RC24_0252

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

150 participants in 1 patient group

Abdominal ultrasound

Experimental group

Description:

All patients included will have an abdominal ultrasound scan

Treatment:

Other: Abdominal ultrasound