Measurement of Gastric Band Stoma Diameter

NCT ID: NCT00984607

Last Updated: 2010-07-28

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

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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barium sulfate tablet

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.

Group Type EXPERIMENTAL

barium sulfate tablet

Intervention Type 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.

Interventions

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barium sulfate tablet

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.

Intervention Type PROCEDURE

Other Intervention Names

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E-Z-EM, Inc., E-Z-DISK NDC10361-778-01

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saint Raphael Healthcare System

OTHER

Sponsor Role lead

Responsible Party

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Hospital of Saint Raphael

Principal Investigators

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Robert G Hayter, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital of Saint Raphael

Locations

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Hospital of Saint Raphael

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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HSR-Gastric Band

Identifier Type: -

Identifier Source: org_study_id

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