Condition or disease | Intervention/treatment |
---|---|
Gastrostomy | 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. 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 : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Evaluation of the Quality of Life of the Caregivers Following the Installation of a Gastrostomy in the Child |
Estimated Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | October 1, 2019 |
Estimated Study Completion Date : | December 31, 2019 |
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. |
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. |
Ages Eligible for Study: | 1 Month to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Child:
Helping :
Exclusion Criteria:
Child:
Helping :
France | |
Assistance Publique Hopitaux de Marseille | |
Marseille Cedex 5, France, 13354 | |
Contact: Alexandre Fabre 04 91 38 60 40 alexander.fabre@ap-hm.fr | |
Contact: Claire Morando 04 91 38 21 83 ext +33 promotion.interne@ap-hm.fr |
Tracking Information | |||||
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First Submitted Date | June 18, 2019 | ||||
First Posted Date | July 11, 2019 | ||||
Last Update Posted Date | July 11, 2019 | ||||
Estimated Study Start Date | July 1, 2019 | ||||
Estimated Primary Completion Date | October 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Comparison of the body mass index [ Time Frame: 10 Months ] Observation of a decrease in body mass index for patient with gastrostomy
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | The Quality of Life of Children With Gastrostomy | ||||
Official Title | Evaluation of the Quality of Life of the Caregivers Following the Installation of a Gastrostomy in the Child | ||||
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. | ||||
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | Children and caregivers with gastronomy | ||||
Condition | 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. |
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Study Groups/Cohorts | 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. Intervention: Other: Gastrostomie
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Not yet recruiting | ||||
Estimated Enrollment |
200 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 31, 2019 | ||||
Estimated Primary Completion Date | October 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria: Child:
Helping :
Exclusion Criteria: Child:
Helping :
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Sex/Gender |
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Ages | 1 Month to 17 Years (Child) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | |||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04016519 | ||||
Other Study ID Numbers | 2018-66 RC18_0352 ( Registry Identifier: APHM ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Assistance Publique Hopitaux De Marseille | ||||
Study Sponsor | Assistance Publique Hopitaux De Marseille | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Assistance Publique Hopitaux De Marseille | ||||
Verification Date | July 2019 |