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Measurement of Gastric Band Stoma Diameter

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ClinicalTrials.gov Identifier: NCT00984607
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : July 28, 2010
Sponsor:
Information provided by:
Saint Raphael Healthcare System

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.

Condition or disease Intervention/treatment Phase
Obesity Procedure: barium sulfate tablet Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Accurate Fluoroscopic Measurement of Adjustable Laparoscopic Gastric Band Stoma Diameter
Study Start Date : December 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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U.S. FDA Resources

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



Primary Outcome Measures :
  1. Correlate accurate fluoroscopic measurement of gastric band stoma diameter with patient symptoms for optimal band stoma adjustment. [ Time Frame: 5 minutes ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984607


Locations
United States, Connecticut
Hospital of Saint Raphael
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Saint Raphael Healthcare System
Investigators
Principal Investigator: Robert G Hayter, MD Hospital of Saint Raphael

Responsible Party: Robert Glenn Hayter, II M.D., Hospital of Saint Raphael
ClinicalTrials.gov Identifier: NCT00984607     History of Changes
Other Study ID Numbers: HSR-Gastric Band
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: July 28, 2010
Last Verified: September 2009

Keywords provided by Saint Raphael Healthcare System:
Laparoscopic Gastric Band
LAP BAND system