Evaluation of the Value of Ultrasound Measurement of Stomach Diameter in Predicting Postoperative Nausea/Vomiting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Evaluate the sensitivity and specificity of the diagnostic character of the gastric diameter ratio at Day 2 / Day 0
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Discharge with nasogastric tube
- •Immediate admission to post-operative intensive care unit
研究组 & 干预措施
Abdominal ultrasound
All patients included will have an abdominal ultrasound scan
干预措施: Abdominal ultrasound (Other)
结局指标
主要结局
Evaluate the sensitivity and specificity of the diagnostic character of the gastric diameter ratio at Day 2 / Day 0
时间窗: Day 2/Day 0 after surgical intervention
Postoperative ileus is defined according to the Vather et al. criteria.
次要结局
- assess the sensitivity and specificity of the gastric diameter ratio at D2/D0 in predicting the onset of inhalation pneumonitis(Day 2/Day 0 after surgical intervention)
- code a computer program to automatically measure the diameter of the gastric antrum(Day 2/Day 0 after surgical intervention)