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NCT05068622 Clinical Trial

Gastric Tube in Pyloric Stenosis

Respiratory Complication Clinical Trial

— SONPYL  

Official title:
Role of the Gastric Tube in the Preoperative Management of Hypertrophic Pyloric Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05068622
Other study ID # PI2021_843_0188
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 15, 2021
Est. completion date December 2023

Study information
Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Xavier DELFORGE, MD
Phone 0322087560
Email delforge.xavier@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 1 Day to 1 Year
Eligibility Inclusion Criteria: - all patients with hypertrophic pyloric stenosis Exclusion Criteria: - refusal of data collection and use from patient's parent or family

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Amiens Nord Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary occurrence of respiratory complications before 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 number of : pre-operative vomiting baseline, pre-surgery
Secondary pre-operative comfort pre-operative comfort is evaluated by the EDIN scale baseline, pre-surgery
Secondary pre-operative dehydration baseline, pre-surgery
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