Nasogastric Tube After Laparoscopic Heller-Dor Myotomy

Achalasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05729971
• Other study ID #: 292/190
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: February 2023
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Achalasia
• Achalasia Cardia
• Esophageal Achalasia

Intervention

Procedure:
• nasogastric tube
The intervention consists in removing or not the nasogastric tube at the end of the surgery.

Locations

Country	Name	City	State
Italy	AOU. policlinico, Federico II	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nausea	clinically evaluating the presence or absence	in the first postoperative day
Primary	vomiting	clinically evaluating the presence or absence	in the first postoperative day
Primary	chest pain	clinically evaluating the presence or absence	in the first postoperative day
Secondary	Length of stay	days of hospitalization from first postoperative day	from the first postoperative day to the third postoperative day
Secondary	First flatus	on which postoperative day the patient had the first flatus.	from the first postoperative day to the third postoperative day
Secondary	Intake liquid diet	when the patient starts drinking	from the first postoperative day to the third postoperative day
Secondary	Intake semi-solid diet (day)	when the patient starts to eat	from the first postoperative day to the third postoperative day
Secondary	postoperative complications	Based on Clavien-Dindo classification	from the first postoperative day to the third postoperative day