Nasogastric Tube After Laparoscopic Heller-Dor Myotomy
Nasogastric Tube After Laparoscopic Heller-Dor Myotomy: do You Really Need it?
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Napoli, Italia, 800131
- AOU. policlinico, Federico II
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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with NGT
In these patients, the nasogastric tube remains after surgery.
It was removed after x-ray test.
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The intervention consists in removing or not the nasogastric tube at the end of the surgery.
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noNGT
In these patients, NGT was removed at the end of surgery.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Nausea
Tidsramme: in the first postoperative day
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clinically evaluating the presence or absence
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in the first postoperative day
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vomiting
Tidsramme: in the first postoperative day
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clinically evaluating the presence or absence
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in the first postoperative day
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chest pain
Tidsramme: in the first postoperative day
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clinically evaluating the presence or absence
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in the first postoperative day
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Length of stay
Tidsramme: from the first postoperative day to the third postoperative day
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days of hospitalization from first postoperative day
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from the first postoperative day to the third postoperative day
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First flatus
Tidsramme: from the first postoperative day to the third postoperative day
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on which postoperative day the patient had the first flatus.
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from the first postoperative day to the third postoperative day
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Intake liquid diet
Tidsramme: from the first postoperative day to the third postoperative day
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when the patient starts drinking
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from the first postoperative day to the third postoperative day
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Inntak halvfast diett (dag)
Tidsramme: fra første postoperative dag til tredje postoperative dag
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når pasienten begynner å spise
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fra første postoperative dag til tredje postoperative dag
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postoperative complications
Tidsramme: from the first postoperative day to the third postoperative day
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Based on Clavien-Dindo classification
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from the first postoperative day to the third postoperative day
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 292/190
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Patients Number Length of stay (day) First flatus (day) Intake liquid diet (day) Intake semi-solid diet (day) Intraoperative complications
Postoperative complications:
- Grade I
- Grade II
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