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Completed

NCT Number: NCT05729971

Nasogastric Tube After Laparoscopic Heller-Dor Myotomy

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.

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Key information

Conditions

Achalasia Achalasia Cardia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU. policlinico, Federico II

Naples, 800131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nasogastric tube

Procedure

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

Primary outcomes

  1. Nausea

    Time frame: in the first postoperative day

    clinically evaluating the presence or absence

  2. vomiting

    Time frame: in the first postoperative day

    clinically evaluating the presence or absence

  3. chest pain

    Time frame: in the first postoperative day

    clinically evaluating the presence or absence

Secondary outcomes

  1. Length of stay

    Time frame: from the first postoperative day to the third postoperative day

    days of hospitalization from first postoperative day

  2. First flatus

    Time frame: from the first postoperative day to the third postoperative day

    on which postoperative day the patient had the first flatus.

  3. Intake liquid diet

    Time frame: from the first postoperative day to the third postoperative day

    when the patient starts drinking

  4. Intake semi-solid diet (day)

    Time frame: from the first postoperative day to the third postoperative day

    when the patient starts to eat

  5. postoperative complications

    Time frame: from the first postoperative day to the third postoperative day

    Based on Clavien-Dindo classification

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2023
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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