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.

Study Overview

• Status: Completed
• Conditions: Achalasia; Achalasia Cardia
• Intervention / Treatment: Procedure: nasogastric tube

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 Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 800131
    • AOU. policlinico, Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Each patient has type I or type II esophageal achalasia and was treated with the Heller-Dor laparoscopic surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
with NGT; In these patients, the nasogastric tube remains after surgery. It was removed after x-ray test.	Procedure: nasogastric tube; 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.

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

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Heller Laparoscopic; Dor Laparoscopic
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia
• Other Study ID Numbers: 292/190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

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