Nasogastric Tube After Laparoscopic Heller-Dor Myotomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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. |
Outcome Measures
Primary Outcome Measures
- Nausea [in the first postoperative day]
clinically evaluating the presence or absence
- vomiting [in the first postoperative day]
clinically evaluating the presence or absence
- chest pain [in the first postoperative day]
clinically evaluating the presence or absence
Secondary Outcome Measures
- Length of stay [from the first postoperative day to the third postoperative day]
days of hospitalization from first postoperative day
- First flatus [from the first postoperative day to the third postoperative day]
on which postoperative day the patient had the first flatus.
- Intake liquid diet [from the first postoperative day to the third postoperative day]
when the patient starts drinking
- Intake semi-solid diet (day) [from the first postoperative day to the third postoperative day]
when the patient starts to eat
- postoperative complications [from the first postoperative day to the third postoperative day]
Based on Clavien-Dindo classification
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AOU. policlinico, Federico II | Napoli | Italy | 800131 |
Sponsors and Collaborators
- Federico II University
Investigators
- Study Director: Giovanni Aprea, professor, Federico II University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
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