The Quality of Life of Children With Gastrostomy

Evaluation of the Quality of Life of the Caregivers Following the Installation of a Gastrostomy in the Child

Study the quality of life with generic questionnaires (17-20), validated and used in other pathologies and chronic diseases of the child. This will allow reproducibility and comparisons to other populations, general or other chronic diseases (acute leukemias ...). This is to conduct a pilot study, preliminary to the construction of a larger study, longitudinal with several evaluation times.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gastrostomy involves creating an opening between the skin and the stomach. It allows the administration of nutrition solutes or food directly into the stomach without passing through the mouth and esophagus. It is a method widely used since the 1980s for enteral nutrition.

In the field of pediatrics, gastrostomy is considered in chronic diseases when enteral nutrition is necessary in the long term. The percutaneous endoscopic method is nowadays one of the most widespread methods that has proven effective on growth and nutrition, with few side effects. Few studies have analyzed children's quality of life after gastrostomy. On the one hand, it increases the perceived health after the pose. It allows a reduction of the stress of the parents, at a distance from the pose, and its insertion would be chosen again by the parents if it were to do again. Meals and medication administration would be easier for parents with a decrease in frequency and time for meals. But on the other hand, its insertion is often difficult for families to experience by changing the diet. The family dynamics is modified and it would lead to logistical constraints for meals or outings . The vision of the corporal schema would also be altered. Following a systematic review of the literature conducted in early 2018, there are currently only 12 cross-sectional studies assessing the quality of life of caregivers after gastrostomy . The numbers vary from 24 to 100 with an average of 65. The results of these studies are generally positive with an improvement in the quality of life and a high degree of satisfaction of carers.

These studies reveal logistical difficulties for social contacts and meals as well as for the re-education of their child. They also raise a lack of information on the part of health professionals. These studies were conducted with different, non-standardized self-questionnaires. None of these studies conducted a direct assessment of the child using a questionnaire designed for them. This assessment of children can be performed in children of understanding age and having a pathology that allows them to communicate. It allows an approach and a direct vision of the quality of life. The investigator's goal is to study the quality of life with generic questionnaires, validated and used in other pathologies and chronic diseases of the child. This will allow reproducibility and comparisons to other populations, general or other chronic diseases (acute leukemias ...). This is to conduct a pilot study, preliminary to the construction of a larger study, longitudinal with several evaluation times.

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 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 month to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children and caregivers with gastronomy

Description

Inclusion Criteria:

Child:

  • 1 month to 17 years old;
  • Not opposed to participating in the study;
  • Whose parent or legal representative did not object to participating in the study;
  • Having a pathology requiring enteral nutrition in the long term exclusive or mixed;
  • Having had a gastrostomy between January 2014 and 2019.

Helping :

  • Be the parent or legal representative of the child who meets the criteria for inclusion and non inclusion;
  • Not opposed to participating in the study;
  • Having the ability to comply with the protocol requirements (in particular: understanding and speaking French).

Exclusion Criteria:

Child:

  • Refusing to participate in the study;
  • Child who has died or no longer has gastrostomy.

Helping :

  • Inability to comply with study protocol, or investigator uncertainty about willingness or ability to comply with protocol requirements;
  • Refusing to participate in the study

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
Intervention / Treatment
Gastrostomie

Gastrostomy involves creating an opening between the skin and the stomach. It allows the administration of nutrition solutes or food directly into the stomach without passing through the mouth and esophagus. It is a method widely used since the 1980s for enteral nutrition.

In the field of pediatrics, gastrostomy is considered in chronic diseases when enteral nutrition is necessary in the long term.

Gastrostomy involves creating an opening between the skin and the stomach. It allows the administration of nutrition solutes or food directly into the stomach without passing through the mouth and esophagus. It is a method widely used since the 1980s for enteral nutrition.

In the field of pediatrics, gastrostomy is considered in chronic diseases when enteral nutrition is necessary in the long term.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the body mass index
Time Frame: 10 Months
Observation of a decrease in body mass index for patient with gastrostomy
10 Months

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 (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

July 10, 2019

First Posted (Actual)

July 11, 2019

Study Record Updates

Last Update Posted (Actual)

July 11, 2019

Last Update Submitted That Met QC Criteria

July 10, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-66
  • RC18_0352 (Registry Identifier: APHM)

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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