GastrostomyNCT04014543
Assessing the Quality of Life of Caregivers and Before and After the Position of Gastronomy
A study testing gastronomy in people with Gastrostomy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The goal of this reasearch project is to study the quality of life of caregivers and children with generic questionnaires, validated and used in other pathologies and chronic diseases of the child. 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?
- gastronomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 30 Oct 2020
- Phase
- Interventional
- 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
Who may be able to join
- Child:
- 1 month to 17 years old;
- Accepting to participate in the study;
- Having a pathology requiring enteral nutrition in the long term exclusive or mixed;
- Having the programming of the insertion of percutaneous gastrostomy in the multidisciplinary pediatric ward.
- Helping :
Show all 14Show fewer
- Parent or representative of the parental authority of a child meeting the inclusion criteria above;
- Accepting to participate in the study;
- Having the ability to comply with the protocol requirements (in particular: understanding and speaking French).
- Siblings:
- 8 to 17 years old;
- Accepting to participate in the study;
- Having the ability to comply with the requirements of the protocol (understanding and speaking French, presenting no sensory, motor, cognitive or severe chronic illness);
- Living in the same home as the sick child.
Who cannot join
- Child:
- Refusing to participate in the study;
- Surgical, radiological or emergency 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.
- Siblings:
- Refusing to participate in the study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
Alexandre Fabre, 04 91 38 60 40, alexander.fabre@ap-hm.fr
Claire Morando, 04 91 38 29 03, promotion.interne@ap-hm.fr
About this study
The goal of this reasearch project is to study the quality of life of caregivers and children 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.
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. It allows weight gain and improves nutritional status. 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 of the child after the placement of the caregiver's point of view. 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. But on the other hand, its insertion is often difficult for families to experience, on the one hand by changing the diet . The family dynamics are modified and it would lead to logistical constraints for meals or outings. The vision of the body diagram would also be altered. Following a systematic review of the literature conducted in early 2018, there are currently only 7 longitudinal prospective studies assessing the quality of life of caregivers before and after gastrostomy. No study is French. The numbers are relatively small. All of these studies assess the quality of life of caregivers only, without assessing the quality of life of the child due to age-related constraints and causal pathology. Six of seven studies show an improvement in the quality of life of caregivers after the pose. The 7th study, which is the only multicentre study, shows no improvement in the quality of life, with an increase in time for care and cost. This is a US study in 3 centers comparing 50 children with and without gastrostomy at 3 assessment points at 0, 3 and 6 months. Children with gastrostomy would require more time for care and a cost. This study found no improvement in caregivers' quality of life and mood on a depression scale. However, the 2 groups were not similar in terms of pathology with more hematological pathologies and fewer degenerative neurological pathologies in the group without gastrostomy. The care, devices and materials are paid in the US which is not the case in France and should not impact on the quality of life. These studies, with the exception of 2 who used the SF-36 questionnaire, were conducted with different and 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 quality of life of the siblings has also not been studied in these studies whereas it is impacted in the chronic diseases in the brothers and sisters. Our goal is to study the quality of life of caregivers and children 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
- gastronomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastronomyOther
Also called investigation
to study the quality of life of caregivers and children with generic questionnaires (13-16), 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 group | Role | What they receive |
|---|---|---|
| Gastrostomy | Experimental | 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: gastronomy |
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 after gastrostomy
Measured: 19 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Jan 2019
- Primary completion31 Jul 2020 (estimated)
- Study completion30 Oct 2020 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- caregivers and children
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT04014543
- Sponsor's protocol ID
- 2018-65
- Other IDs
- 2018-A03284-51
- Status last verified
- Jul 2019
- First submitted
- 18 Jun 2019
- Last updated
- 10 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 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Quality of Life of Caregivers and Before and After the Position of Gastronomy
- ClinicalTrials.gov ID
- NCT04014543
- Acronym / sponsor ID
- 2018-65
- Conditions
- Gastrostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 10 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.
The goal of this reasearch project is to study the quality of life of caregivers and children 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.
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. It allows weight gain and improves nutritional status. 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 of the child after the placement of the caregiver's point of view. 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. But on the other hand, its insertion is often difficult for families to experience, on the one hand by changing the diet . The family dynamics are modified and it would lead to logistical constraints for meals or outings. The vision of the body diagram would also be altered. Following a systematic review of the literature conducted in early 2018, there are currently only 7 longitudinal prospective studies assessing the quality of life of caregivers before and after gastrostomy. No study is French. The numbers are relatively small. All of these studies assess the quality of life of caregivers only, without assessing the quality of life of the child due to age-related constraints and causal pathology. Six of seven studies show an improvement in the quality of life of caregivers after the pose. The 7th study, which is the only multicentre study, shows no improvement in the quality of life, with an increase in time for care and cost. This is a US study in 3 centers comparing 50 children with and without gastrostomy at 3 assessment points at 0, 3 and 6 months. Children with gastrostomy would require more time for care and a cost. This study found no improvement in caregivers' quality of life and mood on a depression scale. However, the 2 groups were not similar in terms of pathology with more hematological pathologies and fewer degenerative neurological pathologies in the group without gastrostomy. The care, devices and materials are paid in the US which is not the case in France and should not impact on the quality of life. These studies, with the exception of 2 who used the SF-36 questionnaire, were conducted with different and 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 quality of life of the siblings has also not been studied in these studies whereas it is impacted in the chronic diseases in the brothers and sisters. Our goal is to study the quality of life of caregivers and children 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- caregivers and children
| Arm | Type | Receives |
|---|---|---|
| Gastrostomy | Experimental | Other: gastronomyGastrostomy 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
Key inclusion criteria (14 listed)
- 1 month to 17 years old;
- Accepting to participate in the study;
- Having a pathology requiring enteral nutrition in the long term exclusive or mixed;
- Having the programming of the insertion of percutaneous gastrostomy in the multidisciplinary pediatric ward.
- Parent or representative of the parental authority of a child meeting the inclusion criteria above;
Key exclusion criteria (8 listed)
- Refusing to participate in the study;
- Surgical, radiological or emergency 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.
- Siblings:
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 |
|---|---|---|
| gastronomyAlso: investigationto study the quality of life of caregivers and children with generic questionnaires (13-16), 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. | Other | Gastrostomy |
Primary outcome
Comparison of the body mass index
Time frame: 19 moths
Observation of a decrease in body mass index after gastrostomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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?
A study testing gastronomy in people with 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 14 inclusion and 8 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 10 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?
Contact Alexandre Fabre (04 91 38 60 40, alexander.fabre@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the body mass index (time frame: 19 moths). 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 10 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.