NCT05068622

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2.8 years

First QC Date

September 15, 2021

Last Update Submit

February 7, 2023

Conditions

Keywords

Hypertrophic Pyloric Stenosisgastric tubeRespiratory Complication

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

Age1 Day - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic

Condition Hierarchy (Ancestors)

Pyloric StenosisGastric Outlet ObstructionStomach DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Xavier DELFORGE, MD

CONTACT

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

Locations