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OpenTrials
Completed

NCT Number: NCT01698827

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital das Clinicas, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tube assessment visits

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)

Primary outcomes

  1. Tube durability

    Time frame: 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 outcomes

  1. Tube rupture

    Time frame: 6 months

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

Other outcomes

  1. Number of previous tube changes

    Time frame: 6 months

    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)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 3, 2012
Registry last updated
Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.