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

U

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems