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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joel Faintuch, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01698827
First received: September 22, 2012
Last updated: September 29, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Gastrostomy Tube Rupture
Gastrostomy Tube Durability
Gastrostomy Tube Convenience
Other: Tube assessment visits

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Tube durability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Tube rupture [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Causes for replacement within the 6 months will be documented, with emphasis on tube or ballooon rupture


Other Outcome Measures:
  • Number of previous tube changes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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)


Enrollment: 100
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Kangaroo
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.
Other: Tube 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)
Cook
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.
Other: Tube 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)
Silmag
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.
Other: Tube 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)
Freka
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.
Other: Tube 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)
Bard
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.
Other: Tube 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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adults on long-term nutritional care requiring prolonged gastrostomy feeding via percutaneous endoscopic gastrostomy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698827

Locations
Brazil
Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077
Sao Paulo, Brazil, 05403-900
Hospital das Clinicas
Sao Paulo, Brazil, 05403900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: Joel Faintuch, MD, PhD Hospital das Clinicas, Sao Paulo, Brazil
Study Director: Paulo Sakai, MD, PhD Hospital das Clinicas, Sao Paulo, Brazil
Principal Investigator: Emanuele L Villela, MD Hospital das Clinicas, Sao Paulo, Brazil
  More Information

Additional Information:
Publications:
Responsible Party: Joel Faintuch, Associate Professor, Department of Gastroenterology, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01698827     History of Changes
Other Study ID Numbers: Gastrotubes5A
Study First Received: September 22, 2012
Last Updated: September 29, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
gastrostomy
tube
endoscopic
replacement
tube rupture
durability
tube loss
balloon rupture

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014