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出境医 / 临床实验 / The Quality of Life of Children With Gastrostomy

The Quality of Life of Children With Gastrostomy

Study Description
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.

Condition or disease Intervention/treatment
Gastrostomy Other: Gastrostomie

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
Layout table for study information
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
Arms 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.

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.


Outcome Measures
Primary Outcome Measures :
  1. Comparison of the body mass index [ Time Frame: 10 Months ]
    Observation of a decrease in body mass index for patient with gastrostomy


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children and caregivers with gastronomy
Criteria

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
Contacts and Locations

Locations
Layout table for location information
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   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Tracking Information
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
 (submitted: July 10, 2019)
Comparison of the body mass index [ Time Frame: 10 Months ]
Observation of a decrease in body mass index for patient with gastrostomy
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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.

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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 10, 2019)
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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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

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