The Quality of Life of Children With Gastrostomy

NCT04016519 | Unknown

• 2 other identifiers: 2018-66RC18_0352
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrostomy

Outcome Measures

Primary Outcomes (1)

• Comparison of the body mass index

  Observation of a decrease in body mass index for patient with gastrostomy

  10 Months

Study Arms (1)

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.

Other: Gastrostomie

Interventions

Gastrostomie OTHER

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.

Gastrostomie

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children and caregivers with gastronomy

You may qualify if:

• Child:
• 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 :
• Not opposed to participating in the study;
• Having the ability to comply with the protocol requirements (in particular: understanding and speaking French).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: July 11, 2019
• Study Start: July 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: December 31, 2019
• Last Updated: July 11, 2019

Record last verified: 2019-07

Locations

FR (1)