The Quality of Life of Children With Gastrostomy

Gastrostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04016519
• Other study ID #: 2018-66
• Secondary ID: RC18_0352
• Status: Not yet recruiting
• Start date: July 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2019
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrostomy

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille Cedex 5

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the body mass index	Observation of a decrease in body mass index for patient with gastrostomy	10 Months