- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05068622
Gastric Tube in Pyloric Stenosis (SONPYL)
February 7, 2023 updated by: Centre Hospitalier Universitaire, Amiens
Role of the Gastric Tube in the Preoperative Management of Hypertrophic Pyloric Stenosis
Pyloric stenosis is a current condition in pediatric surgery.
The medical management prior to surgery consists of ionic correction.
The nasogastric tube is commonly used to prevent gastric fluid inhalation before surgery, but there is no study on it benefits in this specific use.
Other studies suggest that utilization of a gastric tube in pyloric stenosis may increase the duration of the medical treatment.
The aim of the study is to evaluate the benefit of the nasogastric tube to prevent respiratory complications.
This retrospective, monocentric and descriptive study include all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021.
Patients with and without nasogastric tube prior to surgery are compared, regarding respiratory complications define as use of antibiotic, or oxygen therapy or infection in the lungs X-ray before surgery.
The investigators analyze pre-operative data: vomiting, dehydration, time to ionic disorders correction and pain, and also notice the length of hospital stay.
Data during hospitalization are analyzed and will be noticed the last medical contact represent by the post-operative consultation.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xavier Delforge, MD
- Phone Number: 0322087560
- Email: delforge.xavier@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80054
- Recruiting
- CHU Amiens Nord
-
Contact:
- Xavier Delforge, MD
- Phone Number: 0322087560
- Email: delforge.xavier@chu-amiens.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 year (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021
Description
Inclusion Criteria:
- all patients with hypertrophic pyloric stenosis
Exclusion Criteria:
- refusal of data collection and use from patient's parent or family
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
patients with nasogastric tube before surgery
|
patients without nasogastric tube before surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
occurrence of respiratory complications before surgery
Time Frame: baseline, pre-surgery
|
respiratory complications are defined by antibiotic use and/or oxygenotherapy and/or infection in the lungs X-ray before surgery
|
baseline, pre-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of : pre-operative vomiting
Time Frame: baseline, pre-surgery
|
baseline, pre-surgery
|
|
pre-operative comfort
Time Frame: baseline, pre-surgery
|
pre-operative comfort is evaluated by the EDIN scale
|
baseline, pre-surgery
|
pre-operative dehydration
Time Frame: baseline, pre-surgery
|
baseline, pre-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 15, 2021
Primary Completion (ANTICIPATED)
December 1, 2023
Study Completion (ANTICIPATED)
December 1, 2023
Study Registration Dates
First Submitted
September 15, 2021
First Submitted That Met QC Criteria
September 24, 2021
First Posted (ACTUAL)
October 6, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2021_843_0188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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