Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
79 participants
OBSERVATIONAL
2019-01-01
2022-11-30
Brief Summary
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• 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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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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with NGT
In these patients, the nasogastric tube remains after surgery. It was removed after x-ray test.
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.
No interventions assigned to this group
Interventions
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nasogastric tube
The intervention consists in removing or not the nasogastric tube at the end of the surgery.
Eligibility Criteria
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Inclusion Criteria
* patients undergoing laparoscopic Heller-Dor
* patients older than 18 years
* both sexes
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Federico II University
OTHER
Responsible Party
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Giuseppe Palomba
M.D, PhD student
Principal Investigators
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Giovanni Aprea, professor
Role: STUDY_DIRECTOR
Federico II University
Locations
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AOU. policlinico, Federico II
Napoli, , Italy
Countries
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References
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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.
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.
Other Identifiers
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292/190
Identifier Type: -
Identifier Source: org_study_id
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