Clinical trial NCT05729971: Nasogastric Tube After Laparoscopic Heller-Dor Myotomy
Official title: Nasogastric Tube After Laparoscopic Heller-Dor Myotomy: do You Really Need it?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achalasia
Achalasia Cardia
Keywords: Heller Laparoscopic
Dor Laparoscopic
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nausea
timeFrame: in the first postoperative day
measure: vomiting
timeFrame: in the first postoperative day
measure: chest pain
timeFrame: in the first postoperative day
Secondary outcomes:
measure: Length of stay
timeFrame: from the first postoperative day to the third postoperative day
measure: First flatus
timeFrame: from the first postoperative day to the third postoperative day
measure: Intake liquid diet
timeFrame: from the first postoperative day to the third postoperative day
measure: Intake semi-solid diet (day)
timeFrame: from the first postoperative day to the third postoperative day
measure: postoperative complications
timeFrame: from the first postoperative day to the third postoperative day
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: AOU. policlinico, Federico II
Study officials:
affiliation: Federico II University
name: Giovanni Aprea, professor
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.