AchalasiaNCT05729971
Nasogastric Tube After Laparoscopic Heller-Dor Myotomy
An observational study of Achalasia and Achalasia Cardia, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia, Achalasia Cardia
- What is being tested?
- nasogastric tube
- Type of treatment
- Surgery or procedure
- How many people
- 79 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Each patient has type I or type II esophageal achalasia and was treated with the Heller-Dor laparoscopic surgery.
Who may be able to join
- patients with achalasia of type I and II
- patients undergoing laparoscopic Heller-Dor
- patients older than 18 years
- both sexes
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Achalasia, Achalasia Cardia
- Being tested
- nasogastric tube
- Keywords
- Heller Laparoscopic, Dor Laparoscopic
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasogastric tubeProcedure or surgery
The intervention consists in removing or not the nasogastric tube at the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| with NGT | In these patients, the nasogastric tube remains after surgery. It was removed after x-ray test. Receives: Procedure: nasogastric tube | |
| noNGT | In these patients, NGT was removed at the end of surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea
clinically evaluating the presence or absence
Measured: in the first postoperative day
vomiting
clinically evaluating the presence or absence
Measured: in the first postoperative day
chest pain
clinically evaluating the presence or absence
Measured: in the first postoperative day
Secondary outcomes (5)
Length of stay
days of hospitalization from first postoperative day
Measured: from the first postoperative day to the third postoperative day
First flatus
on which postoperative day the patient had the first flatus.
Measured: from the first postoperative day to the third postoperative day
Intake liquid diet
when the patient starts drinking
Measured: from the first postoperative day to the third postoperative day
Intake semi-solid diet (day)
when the patient starts to eat
Measured: from the first postoperative day to the third postoperative day
postoperative complications
Based on Clavien-Dindo classification
Measured: from the first postoperative day to the third postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Jan 2019
- Primary completion30 Jul 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Palomba, Federico II University
- Investigators
- Giovanni Aprea, professor, Study director, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729971
- Sponsor's protocol ID
- 292/190
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: 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
Publications
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.
PubMed 22309323Andolfi 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.
PubMed 30690706Arcerito 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.
PubMed 35967962
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasogastric Tube After Laparoscopic Heller-Dor Myotomy: do You Really Need it?
- ClinicalTrials.gov ID
- NCT05729971
- Acronym / sponsor ID
- 292/190
- Conditions
- Achalasia, Achalasia Cardia
- Keywords
- Heller Laparoscopic, Dor Laparoscopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with NGT | – | Procedure: nasogastric tubeIn these patients, the nasogastric tube remains after surgery. It was removed after x-ray test. |
| noNGT | – | –In these patients, NGT was removed at the end of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each patient has type I or type II esophageal achalasia and was treated with the Heller-Dor laparoscopic surgery.
Key inclusion criteria (4 listed)
- patients with achalasia of type I and II
- patients undergoing laparoscopic Heller-Dor
- patients older than 18 years
- both sexes
Key exclusion criteria (7 listed)
- pregnant patients;
- patients a history of abdominal surgery;
- body mass index (BMI) >40;
- American Society of Anesthesiology (ASA) score >4;
- megaesophagus;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasogastric tubeThe intervention consists in removing or not the nasogastric tube at the end of the surgery. | Procedure or surgery | with NGT |
Primary outcome
Nausea
Time frame: in the first postoperative day
clinically evaluating the presence or absence
vomiting
Time frame: in the first postoperative day
clinically evaluating the presence or absence
chest pain
Time frame: in the first postoperative day
clinically evaluating the presence or absence
5 secondary outcomes
Length of stay
Time frame: from the first postoperative day to the third postoperative day
First flatus
Time frame: from the first postoperative day to the third postoperative day
Intake liquid diet
Time frame: from the first postoperative day to the third postoperative day
Intake semi-solid diet (day)
Time frame: from the first postoperative day to the third postoperative day
postoperative complications
Time frame: from the first postoperative day to the third postoperative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 22309323Hoshino 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.
- Background: PubMed 30690706Andolfi 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.
- Background: PubMed 35967962Arcerito 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.
- Individual participant dataSharing planned: Undecided. 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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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Aprea, professor study director
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia and Achalasia Cardia, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea (time frame: in the first postoperative day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05729971, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.