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

University of Sao Paulo100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Gastrostomy Tube Rupture Gastrostomy Tube Durability Gastrostomy Tube Convenience

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Tube durability

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.

Time frame: 6 months

Secondary Outcomes

Tube rupture

Causes for replacement within the 6 months will be documented, with emphasis on tube or ballooon rupture