Nasogastric Tube After Laparoscopic Heller-Dor Myotomy
Nasogastric Tube After Laparoscopic Heller-Dor Myotomy: do You Really Need it?
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Napoli、意大利、800131
- AOU. policlinico, Federico II
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- patients with achalasia of type I and II
- patients undergoing laparoscopic Heller-Dor
- patients older than 18 years
- both sexes
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
with NGT
In these patients, the nasogastric tube remains after surgery.
It was removed after x-ray test.
|
The intervention consists in removing or not the nasogastric tube at the end of the surgery.
|
|
noNGT
In these patients, NGT was removed at the end of surgery.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Nausea
大体时间：in the first postoperative day
|
clinically evaluating the presence or absence
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in the first postoperative day
|
|
vomiting
大体时间：in the first postoperative day
|
clinically evaluating the presence or absence
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in the first postoperative day
|
|
chest pain
大体时间：in the first postoperative day
|
clinically evaluating the presence or absence
|
in the first postoperative day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Length of stay
大体时间：from the first postoperative day to the third postoperative day
|
days of hospitalization from first postoperative day
|
from the first postoperative day to the third postoperative day
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First flatus
大体时间：from the first postoperative day to the third postoperative day
|
on which postoperative day the patient had the first flatus.
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from the first postoperative day to the third postoperative day
|
|
Intake liquid diet
大体时间：from the first postoperative day to the third postoperative day
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when the patient starts drinking
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from the first postoperative day to the third postoperative day
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摄入半固体饮食（天）
大体时间：from the first postoperative day to the third postoperative day
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当病人开始进食时
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from the first postoperative day to the third postoperative day
|
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postoperative complications
大体时间：from the first postoperative day to the third postoperative day
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Based on Clavien-Dindo classification
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from the first postoperative day to the third postoperative day
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合作者和调查者
出版物和有用的链接
一般刊物
- Hoshino M, Omura N, Yano F, Tsuboi K, Kashiwagi H, Yanaga K. Immunohistochemical study of the muscularis externa of the esophagus in achalasia patients. Dis Esophagus. 2013 Jan;26(1):14-21. doi: 10.1111/j.1442-2050.2011.01318.x. Epub 2012 Feb 6.
- Andolfi C, Fisichella PM. Meta-analysis of clinical outcome after treatment for achalasia based on manometric subtypes. Br J Surg. 2019 Mar;106(4):332-341. doi: 10.1002/bjs.11049. Epub 2019 Jan 28.
- Arcerito M, Jamal MM, Perez MG, Kaur H, Sundahl A, Moon JT. Esophageal Achalasia: From Laparoscopic to Robotic Heller Myotomy and Dor Fundoplication. JSLS. 2022 Jul-Sep;26(3):e2022.00027. doi: 10.4293/JSLS.2022.00027.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 292/190
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Patients Number Length of stay (day) First flatus (day) Intake liquid diet (day) Intake semi-solid diet (day) Intraoperative complications
Postoperative complications:
- Grade I
- Grade II
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