Measurement of Gastric Band Stoma Diameter
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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 |
- 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 |
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| United States, Connecticut | |
| Hospital of Saint Raphael | |
| New Haven, Connecticut, United States, 06511 | |
| 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 June 17, 2013