GastrostomyNCT04016519
The Quality of Life of Children With Gastrostomy
An observational study of Gastrostomy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 ...). Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Gastrostomy
- What is being tested?
- Gastrostomie
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and caregivers with gastronomy
Who may be able to join
- 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.
Show all 10Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hopitaux de Marseille
Marseille, 13354
Alexandre Fabre, 04 91 38 60 40, alexander.fabre@ap-hm.fr
Claire Morando, 04 91 38 21 83 ext. +33, promotion.interne@ap-hm.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastrostomy
- Being tested
- Gastrostomie
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrostomieOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Gastrostomie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the body mass index
Observation of a decrease in body mass index for patient with gastrostomy
Measured: 10 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Jul 2019 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016519
- Sponsor's protocol ID
- 2018-66
- Other IDs
- RC18_0352
- Status last verified
- Jul 2019
- First submitted
- 18 Jun 2019
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Life of the Caregivers Following the Installation of a Gastrostomy in the Child
- ClinicalTrials.gov ID
- NCT04016519
- Acronym / sponsor ID
- 2018-66
- Conditions
- Gastrostomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastrostomie | – | Other: GastrostomieGastrostomy 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. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and caregivers with gastronomy
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- Refusing to participate in the study;
- Child who has died or no longer has gastrostomy.
- Inability to comply with study protocol, or investigator uncertainty about willingness or ability to comply with protocol requirements;
- Refusing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastrostomieGastrostomy 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 |
Primary outcome
Comparison of the body mass index
Time frame: 10 Months
Observation of a decrease in body mass index for patient with gastrostomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrostomy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the body mass index (time frame: 10 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.