Measurement of Gastric Band Stoma Diameter
Accurate Fluoroscopic Measurement of Adjustable Laparoscopic Gastric Band Stoma Diameter
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to correlate accurate fluoroscopic measurement of gastric band stoma diameter with patient symptoms for optimal band stoma adjustment. Administration of a barium tablet to gastric band patients with dilute liquid barium allows the accurate measurement of the band stoma diameter. The technique is quick, easy to perform, and eliminates magnification error intrinsic to fluoroscopy. The study data suggests the optimal calibrated gastric band stoma diameter is 3.0 mm. The accurate fluoroscopic measurement of gastric band stoma diameter can optimize band stoma adjustment and improve patient outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Dec 2008
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 24, 2009
CompletedFirst Posted
Study publicly available on registry
September 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJuly 28, 2010
September 1, 2009
1 year
September 24, 2009
July 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlate accurate fluoroscopic measurement of gastric band stoma diameter with patient symptoms for optimal band stoma adjustment.
5 minutes
Study Arms (1)
barium sulfate tablet
EXPERIMENTALAfter a standard upper GI evaluation, oral administration of a standard 13 mm barium sulfate tablet was performed and swallowed with dilute liquid barium during fluoroscopic monitoring.
Interventions
After a standard upper GI evaluation, oral administration of a standard 13 mm barium sulfate tablet was performed and swallowed with dilute liquid barium during fluoroscopic monitoring. A spot radiograph was obtained once the barium tablet was in the gastric pouch and the dilute liquid barium was passing through the gastric band stoma.
Eligibility Criteria
You may qualify if:
- eating
- s/p LAP BAND placement
You may not qualify if:
- immediately post operative
- s/p LAP BAND placement
- significant abnormality found on preceding standard upper GI series
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of Saint Raphael
New Haven, Connecticut, 06511, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert G Hayter, MD
Hospital of Saint Raphael
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 24, 2009
First Posted
September 25, 2009
Study Start
December 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
July 28, 2010
Record last verified: 2009-09