Measurement of Gastric Band Stoma Diameter

This study has been completed.
Sponsor:
Information provided by:
Saint Raphael Healthcare System
ClinicalTrials.gov Identifier:
NCT00984607
First received: September 24, 2009
Last updated: July 26, 2010
Last verified: September 2009
  Purpose

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 Intervention
Obesity
Procedure: barium sulfate tablet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Accurate Fluoroscopic Measurement of Adjustable Laparoscopic Gastric Band Stoma Diameter

Resource links provided by NLM:


Further study details as provided by Saint Raphael Healthcare System:

Primary Outcome Measures:
  • Correlate accurate fluoroscopic measurement of gastric band stoma diameter with patient symptoms for optimal band stoma adjustment. [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: September 24, 2009
Last Updated: July 26, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014