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NCT01698827

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

NCT ID: NCT01698827

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Gastrostomy Tube Rupture Gastrostomy Tube Durability Gastrostomy Tube Convenience

Keywords

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gastrostomy tube endoscopic replacement tube rupture durability tube loss balloon rupture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Tube assessment visits

Intervention Type OTHER

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.

Tube assessment visits

Intervention Type OTHER

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.

Tube assessment visits

Intervention Type OTHER

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.

Tube assessment visits

Intervention Type OTHER

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.

Tube assessment visits

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Joel Faintuch

Associate Professor, Department of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joel Faintuch, MD, PhD

Role: STUDY_CHAIR

Hospital das Clinicas, Sao Paulo, Brazil

Paulo Sakai, MD, PhD

Role: STUDY_DIRECTOR

Hospital das Clinicas, Sao Paulo, Brazil

Emanuele L Villela, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clinicas, Sao Paulo, Brazil

Locations

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Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077

São Paulo, São Paulo, Brazil

Site Status

Hospital das Clinicas

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND

PMID: 21429018 (View on PubMed)

Villela EL, Sakai P, Almeida MR, Moura EG, Faintuch J. Endoscopic gastrostomy replacement tubes: long-term randomized trial with five silicone commercial models. Clin Nutr. 2014 Apr;33(2):221-5. doi: 10.1016/j.clnu.2013.04.015. Epub 2013 Apr 30.

Reference Type DERIVED

PMID: 23672806 (View on PubMed)

Other Identifiers

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Gastrotubes5A

Identifier Type: -

Identifier Source: org_study_id