Nasogastric Tube After Laparoscopic Heller-Dor Myotomy: do You Really Need it?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- vomiting
研究概览
简要总结
The goal of this prospective observational study is to evaluate the role of nasogastric tube (NGT) in patients with achalasia underwent to Heller-Dor laparoscopic. The main question it aims to answer are:
• If it is possible to remove NGT at the end of surgery. Participants will be dived in two groups: the first one with NGT after surgery and second one without NGT (noNGT).
If there is a comparison group: Researchers will compare group NGT and group noNGT to see if routine placement of NGT is useless.
详细描述
Achalasia is a rare disease characterized by dysfunction of low oesophageal sphincter. This disease is divided according to Chicago classification into three subtypes.
Laparoscopic Heller - Dor is a important treatment of types I and II Achalasia. There are several studies evaluating the NGT in colorectal, hepatic, urologic, thoracic, otorhinolaryngology, gastric and esophageal surgery. Its use in postoperative period in achalasic patients is not yet clear.
Historically, NGT has been used to reduce gastric distention, nausea, vomiting and chest pain.
The aim of our study is to value the role of NGT for this surgery. We prospectively enrolled achalasic patients undergoing laparoscopic Heller -Dor .
The NGT group and noNGT were compared in terms of perioperative outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 with achalasia of type I and II
- •patients undergoing laparoscopic Heller-Dor
- •patients older than 18 years
- •both sexes
排除标准
- •pregnant patients;
- •patients a history of abdominal surgery;
- •body mass index (BMI) >40;
- •American Society of Anesthesiology (ASA) score >4;
- •megaesophagus;
- •III type Achalasia;
- •previously treated for this disease.
结局指标
主要结局
vomiting
时间窗: in the first postoperative day
clinically evaluating the presence or absence
Nausea
时间窗: in the first postoperative day
clinically evaluating the presence or absence
chest pain
时间窗: in the first postoperative day
clinically evaluating the presence or absence
次要结局
- Intake liquid diet(from the first postoperative day to the third postoperative day)
- postoperative complications(from the first postoperative day to the third postoperative day)
- Length of stay(from the first postoperative day to the third postoperative day)
- First flatus(from the first postoperative day to the third postoperative day)
- Intake semi-solid diet (day)(from the first postoperative day to the third postoperative day)
研究者
Giuseppe Palomba
M.D, PhD student
Federico II University