Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models

University of Sao Paulo

Status: Completed

Conditions: Gastrostomy Tube Convenience; Gastrostomy Tube Durability; Gastrostomy Tube Rupture

Treatments: Other: Tube assessment visits

Study type: Observational

Funder types: Other

Identifiers

NCT01698827

Gastrotubes5A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 5 patient groups

Kangaroo

Description:

20 patients managed by "Kangaroo" gastrostomy tubes. Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.

Treatment:

Other: Tube assessment visits

Cook

Description:

20 patients receiving "Wilson Cook" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.

Treatment:

Other: Tube assessment visits

Silmag

Description:

20 patients managed by "Silmag" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.

Treatment:

Other: Tube assessment visits

Freka

Description:

20 patients carrying "Freka" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.

Treatment:

Other: Tube assessment visits

Bard

Description:

20 patients using the "Bard" gastrostomy tube. Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.

Treatment:

Other: Tube assessment visits