- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016519
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 Overview
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Marseille Cedex 5, France, 13354
- Assistance Publique Hopitaux de Marseille
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Contact:
- Alexandre Fabre
- Phone Number: 04 91 38 60 40
- Email: alexander.fabre@ap-hm.fr
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Contact:
- Claire Morando
- Phone Number: +33 04 91 38 21 83
- Email: promotion.interne@ap-hm.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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Observation of a decrease in body mass index for patient with gastrostomy
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10 Months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Gastrostomy
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University Health Network, TorontoUnknown
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Centre Hospitalier de ValenceRecruitingGastrostomy | Gastrostomy ComplicationsFrance
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CoapTechChildren's Hospital of Philadelphia; Columbia University; Children's National...RecruitingGastrostomy | Pediatric Disorder | Ultrasound | Gastrostomy ComplicationsUnited States
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University of TennesseeLe Bonheur Children's HospitalCompletedGastrostomy Complications | Gastrostomy Tube Site ComplicationUnited States
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University Medical Centre LjubljanaEuropean Society of Pediatric Gastroenterology, Hepatology and NutritionUnknownGastrostomyUnited Arab Emirates, United Kingdom, Belgium, Croatia, Italy, Slovenia, Switzerland
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University of Sao PauloCompletedGastrostomy Tube Rupture | Gastrostomy Tube Durability | Gastrostomy Tube ConvenienceBrazil
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CoapTechLondon Health Sciences CentreCompleted
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Yonsei UniversityCompleted
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St. Louis UniversityTerminated