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

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

Study Locations

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

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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