Measurement of Gastric Band Stoma Diameter

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Saint Raphael

New Haven, Connecticut, 06511, United States

About this study

Ten patients presenting for an upper GI series with laparoscopically placed gastric bands were enrolled after informed consent. 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. Post-processing software used the longest radiographic dimension of the 13 mm barium tablet as the size reference to calibrate measurement of the gastric band stoma diameter.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

eating
s/p LAP BAND placement

Exclusion criteria

immediately post operative
s/p LAP BAND placement
significant abnormality found on preceding standard upper GI series

Treatment and study plan

barium sulfate tablet

Procedure

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.

Other names: E-Z-EM, Inc., E-Z-DISK NDC10361-778-01

Primary outcomes

Correlate accurate fluoroscopic measurement of gastric band stoma diameter with patient symptoms for optimal band stoma adjustment.

Time frame: 5 minutes

Sponsors and collaborators

Lead sponsor

Saint Raphael Healthcare System

Other

Registry information

Official study title

Accurate Fluoroscopic Measurement of Adjustable Laparoscopic Gastric Band Stoma Diameter

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Sep 25, 2009
Registry last updated: Jul 28, 2010

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.

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Completed