Measurement of Gastric Band Stoma Diameter

July 26, 2010 updated by: Saint Raphael Healthcare System

Accurate Fluoroscopic Measurement of Adjustable Laparoscopic 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Hospital of Saint Raphael

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Other Names:
  • E-Z-EM, Inc., E-Z-DISK NDC10361-778-01

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlate accurate fluoroscopic measurement of gastric band stoma diameter with patient symptoms for optimal band stoma adjustment.
Time Frame: 5 minutes
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Raphael Healthcare System

Investigators

  • Principal Investigator: Robert G Hayter, MD, Hospital of Saint Raphael

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria

September 24, 2009

First Posted (Estimate)

September 25, 2009

Study Record Updates

Last Update Posted (Estimate)

July 28, 2010

Last Update Submitted That Met QC Criteria

July 26, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSR-Gastric Band

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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