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

Gastrostomy Tube Convenience Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698827
• Other study ID #: Gastrotubes5A
• Status: Completed
• Phase: N/A
• First received: September 22, 2012
• Last updated: September 29, 2012
• Start date: January 2012
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastrostomy Tube Convenience
• Gastrostomy Tube Durability
• Gastrostomy Tube Rupture
• Rupture

Intervention

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)

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas	Sao Paulo
Brazil	Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Campoli P, Cardoso D, Turchi M, Mota O. Clinical trial: a randomized study comparing the durability of silicone and latex percutaneous endoscopic gastrostomy tubes. Dig Endosc. 2011 Apr;23(2):135-9. doi: 10.1111/j.1443-1661.2010.01051.x. Epub 2010 Dec 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of previous tube changes	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)	6 months	No
Primary	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.	6 months	No
Secondary	Tube rupture	Causes for replacement within the 6 months will be documented, with emphasis on tube or ballooon rupture	6 months	No