Efficacy of Carbonated Beverages in the Resolution of Alimentary Esophageal Impaction: a Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Efficacy of carbonated beverage for disimpaction
研究概览
简要总结
Objectives: To evaluate the efficacy of the administration of carbonated beverages in the resolution of dietary esophageal impaction, and to identify subgroups in which their effectiveness may be different: patients with/without esophageal diseases, with/without a history of impaction.
Methods: A clinical trial was conducted randomizing consecutive patients with a clinical diagnosis of dietary esophageal impaction to receive 200cc of carbonated drink or not at all, excluding patients with a previous diagnosis of non-esophageal stenosis that could not be overcome with a gastroscope and suspected impaction by non-alimentary foreign bodies, spines or bones. Subsequently, an endoscopic evaluation will be carried out in all cases, checking the presence or absence of a foreign body and removing it if necessary, as well as assessing and recording the possible underlying esophageal pathology.
A telephone follow-up will be carried out after 7 days, recording possible adverse events.
详细描述
METHODOLOGY
- Design: Randomized multicenter clinical trial.
- Period: patients treated in the Emergency Department with a clinical diagnosis of esophageal foreign body impaction (cervical or retrosternal foreign body sensation, hypersalivation, inability to swallow) will be collected with indication by clinical practice by the emergency physician who evaluates them for upper gastrointestinal endoscopy.
- Population selection:
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Scope: patients treated in the Emergency Department of the participating hospitals.
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Inclusion and exclusion criteria:
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The inclusion criteria are:
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Patients who come to the Emergency Department with a clinical diagnosis of esophageal impaction due to food bolus (determined by at least one of the following symptoms: sialorrhea, inability to swallow or cervical or retrosternal foreign body sensation) that requires endoscopic extraction.
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Age greater than or equal to 18 years of age. The inclusion criterion related to age refers to the age at the date of signing the informed consent form.
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The exclusion criteria are:
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Pregnancy.
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Benign or malignant esophageal stricture that cannot be overcome with a conventional gastroscope.
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Patients with intraesophageal prostheses
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Non-food foreign body (includes fish bones or bones)
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Ingestion of some type of carbonated beverage after impaction.
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Contraindication for the administration of carbonated drink (Cola-Cola) due to allergy or intolerance to any of its components.
3.3. Recruitment procedure: all patients treated in the Emergency Department of the aforementioned hospitals with a clinical diagnosis of esophageal food impaction who meet the inclusion criteria and do not meet the exclusion criteria will be invited by the Emergency Department to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •-Patients who come to the Emergency Department with a clinical diagnosis of esophageal impaction due to food bolus (determined by at least one of the following symptoms: sialorrhea, inability to swallow or cervical or retrosternal foreign body sensation) that requires endoscopic extraction.
- •Age greater than or equal to 18 years of age. The inclusion criterion related to age refers to the age at the date of signing the informed consent form.
排除标准
- •-Pregnancy.
- •Benign or malignant esophageal stricture that cannot be overcome with a conventional gastroscope.
- •Patients with intraesophageal prostheses
- •Non-food foreign body (includes fish bones or bones)
- •Ingestion of some type of carbonated beverage after impaction.
- •Contraindication for the administration of carbonated drink (Cola-Cola) due to allergy or intolerance to any of its components.
研究组 & 干预措施
Intervention group
200 ml of Coca-Cola will be administered and must be ingested within a maximum of 10 minutes
干预措施: Coca-cola (Dietary Supplement)
Control group
will not receive any type of medication or drink
结局指标
主要结局
Efficacy of carbonated beverage for disimpaction
时间窗: 3 years
Number of patients with esophageal impaction resolved with the carbonated beverage
次要结局
未报告次要终点
研究者
Marina de Benito Sanz
Principal investigator
Hospital del Rio Hortega