Nasogastric Tube After Laparoscopic Heller-Dor Myotomy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Nasogastric Tube After Laparoscopic Heller-Dor Myotomy: do You Really Need it?

Conditions
-----------------
Achalasia, Achalasia Cardia

Intervention / Treatment
-----------------
* Procedure: nasogastric tube


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with NGT<br>In these patients, the nasogastric tube remains after surgery. It was removed after x-ray test. | Procedure: nasogastric tube<br>* The intervention consists in removing or not the nasogastric tube at the end of the surgery.<br>|
| noNGT<br>In these patients, NGT was removed at the end of surgery. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea | clinically evaluating the presence or absence | in the first postoperative day | 
| vomiting | clinically evaluating the presence or absence | in the first postoperative day | 
| chest pain | clinically evaluating the presence or absence | in the first postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | days of hospitalization from first postoperative day | from the first postoperative day to the third postoperative day | 
| First flatus | on which postoperative day the patient had the first flatus. | from the first postoperative day to the third postoperative day | 
| Intake liquid diet | when the patient starts drinking | from the first postoperative day to the third postoperative day | 
| Intake semi-solid diet (day) | when the patient starts to eat | from the first postoperative day to the third postoperative day | 
| postoperative complications | Based on Clavien-Dindo classification | from the first postoperative day to the third postoperative day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heller Laparoscopic, Dor Laparoscopic