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Nasogastric Tube After Laparoscopic Heller-Dor Myotomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05729971
Enrollment
79
Registered
2023-02-15
Start date
2019-01-01
Completion date
2022-11-30
Last updated
2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia, Achalasia Cardia

Keywords

Heller Laparoscopic, Dor Laparoscopic

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.

Interventions

PROCEDUREnasogastric tube

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

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Nauseain the first postoperative dayclinically evaluating the presence or absence
vomitingin the first postoperative dayclinically evaluating the presence or absence
chest painin the first postoperative dayclinically evaluating the presence or absence

Secondary

MeasureTime frameDescription
Intake semi-solid diet (day)from the first postoperative day to the third postoperative daywhen the patient starts to eat
Length of stayfrom the first postoperative day to the third postoperative daydays of hospitalization from first postoperative day
postoperative complicationsfrom the first postoperative day to the third postoperative dayBased on Clavien-Dindo classification
First flatusfrom the first postoperative day to the third postoperative dayon which postoperative day the patient had the first flatus.
Intake liquid dietfrom the first postoperative day to the third postoperative daywhen the patient starts drinking

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026