Nasogastric Tube After Laparoscopic Heller-Dor Myotomy

Completed

• Conditions: Achalasia; Achalasia Cardia
• Interventions: Procedure: nasogastric tube

• Registration Number: NCT05729971
• Lead Sponsor: Federico II University

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-07-30
• Study Completion: 2022-11-30
• Study First Submitted: 2023-01-27
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-14
• Last Update Submitted: 2023-02-14
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
with NGT	nasogastric tube	In these patients, the nasogastric tube remains after surgery. It was removed after x-ray test.

Primary Outcome Measures

Name	Time	Method
vomiting	in the first postoperative day	clinically evaluating the presence or absence
Nausea	in the first postoperative day	clinically evaluating the presence or absence
chest pain	in the first postoperative day	clinically evaluating the presence or absence

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AOU. policlinico, Federico II; 🇮🇹 Napoli, Italy