Gastric Tube in Pyloric Stenosis
SONPYL
Role of the Gastric Tube in the Preoperative Management of Hypertrophic Pyloric Stenosis
1 other identifier
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2021
CompletedFirst Submitted
Initial submission to the registry
September 15, 2021
CompletedFirst Posted
Study publicly available on registry
October 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFebruary 8, 2023
February 1, 2023
2.8 years
September 15, 2021
February 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
number of : pre-operative vomiting
baseline, pre-surgery
pre-operative comfort
baseline, pre-surgery
pre-operative dehydration
baseline, pre-surgery
Study Arms (2)
patients with nasogastric tube before surgery
patients without nasogastric tube before surgery
Eligibility Criteria
all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021
You may qualify if:
- all patients with hypertrophic pyloric stenosis
You may not qualify if:
- refusal of data collection and use from patient's parent or family
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens Nord
Amiens, 80054, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2021
First Posted
October 6, 2021
Study Start
February 15, 2021
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share