Gastrostomy Tube Convenience, Gastrostomy Tube Durability, Gastrostomy Tube Rupture
Conditions
Keywords
gastrostomy, tube, endoscopic, replacement, tube rupture, durability, tube loss, balloon rupture
Brief summary
Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in the market, however durability is variable. In a prospective randomized study, five commercial devices available in the market will be tested in 20 consecutive patients each. Tube performance will be observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design and material will influence outcome.
Detailed description
Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in the market, however durability is variable. In a prospective randomized study, five commercial devices available in the market will be tested in 20 consecutive patients each,in patients submitted to long-term outpatient nutritional support. Tube performance will be observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design and material will influence outcome.This study is important because tube dysfunction and unscheduled changes are expensive troubles that disrupt the nutritional protocol and are responsible for multiple inconveniences to the patient and the caretaker.
Interventions
OTHERTube assessment visits
Patients will return every 2 months for clinical questionnaire about leaks, obstructions or other dysfunctions of the tube. Objective tube examination for cracks, rupture, obstruction or dislodgement, along with replacement if necessary, will be carried out (total of 3 visits/6 months)
Sponsors
University of Sao Paulo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adults undergoing long-term home enteral nutrition via percutaneous endoscopic gastrostomy due to neurologic conditions or dysphagia. * registered at the outpatient endoscopy service * clinical stable and with the possibility of returning for scheduled visits * expected duration of enteral feeding \> 6 months
Exclusion criteria
* Sepsis, * shock, * coma, * other types of digestive access (surgical gastrostomy, jejunostomy) * terminal disease, * lack of cooperation, * refusal to participate in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tube durability | 6 months | Durability of the tube will be calculated as days in use till need for replacement, within the time frame of 6 months of observation. 180 days of continuous use will correspond to 100% durability, and 18 days of use as 10% durability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tube rupture | 6 months | Causes for replacement within the 6 months will be documented, with emphasis on tube or ballooon rupture |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of previous tube changes | 6 months | Tube outcome will be analyzed in the light of number of previous tube changes in the patients (first tube/no previous change vs. patients on long-term treatment with multiple tube changes) |
Countries
Brazil
Outcome results
None listed