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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Evaluate the sensitivity and specificity of the diagnostic character of the gastric diameter ratio at Day 2 / Day 0 [Срок оценки: Day 2/Day 0 after surgical intervention]

Вторичные конечные точки (2)

• assess the sensitivity and specificity of the gastric diameter ratio at D2/D0 in predicting the onset of inhalation pneumonitis [Срок оценки: Day 2/Day 0 after surgical intervention]
• code a computer program to automatically measure the diameter of the gastric antrum [Срок оценки: Day 2/Day 0 after surgical intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• University Hospital of Angers — Angers

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗