NCT05729971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

3.6 years

First QC Date

January 27, 2023

Last Update Submit

February 14, 2023

Conditions

AchalasiaAchalasia Cardia

Keywords

Heller LaparoscopicDor Laparoscopic

Outcome Measures

Primary Outcomes (3)

  • Nausea

    clinically evaluating the presence or absence

    in the first postoperative day

  • vomiting

    clinically evaluating the presence or absence

    in the first postoperative day

  • chest pain

    clinically evaluating the presence or absence

    in the first postoperative day

Secondary Outcomes (5)

  • Length of stay

    from the first postoperative day to the third postoperative day

  • First flatus

    from the first postoperative day to the third postoperative day

  • Intake liquid diet

    from the first postoperative day to the third postoperative day

  • Intake semi-solid diet (day)

    from the first postoperative day to the third postoperative day

  • postoperative complications

    from the first postoperative day to the third postoperative day

Study Arms (2)

with NGT

In these patients, the nasogastric tube remains after surgery. It was removed after x-ray test.

Procedure: nasogastric tube

noNGT

In these patients, NGT was removed at the end of surgery.

Interventions

nasogastric tubePROCEDURE

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

with NGT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Each patient has type I or type II esophageal achalasia and was treated with the Heller-Dor laparoscopic surgery.

You may qualify if:

  • patients with achalasia of type I and II
  • patients undergoing laparoscopic Heller-Dor
  • patients older than 18 years
  • both sexes

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU. policlinico, Federico II

Napoli, 800131, Italy

Location

Related Publications (3)

  • 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.

    PMID: 22309323BACKGROUND

  • 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.

    PMID: 30690706BACKGROUND

  • 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.

    PMID: 35967962BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Giovanni Aprea, professor

    Federico II University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, PhD student

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 15, 2023

Study Start

January 1, 2019

Primary Completion

July 30, 2022

Study Completion

November 30, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations

IT(1)