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

Completed

• Conditions: Gastrostomy Tube Rupture; Gastrostomy Tube Durability; Gastrostomy Tube Convenience
• Interventions: Other: Tube assessment visits

• Registration Number: NCT01698827
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-09
• Study First Submitted: 2012-09-22
• Study First Submitted QC: 2012-09-29
• Last Update Submitted: 2012-09-29
• Study First Posted: 2012-10-03
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Read More

Exclusion Criteria

• Sepsis,
• shock,
• coma,
• other types of digestive access (surgical gastrostomy, jejunostomy)
• terminal disease,
• lack of cooperation,
• refusal to participate in the protocol

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kangaroo	Tube assessment visits	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.
Cook	Tube assessment visits	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.
Silmag	Tube assessment visits	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.
Freka	Tube assessment visits	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.
Bard	Tube assessment visits	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (2)

Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077; 🇧🇷 Sao Paulo, Brazil

Hospital das Clinicas; 🇧🇷 Sao Paulo, Brazil