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NCT03239405 Clinical Trial

Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy

Surgical Procedure, Unspecified Clinical Trial

— VS1  

Official title:
Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03239405
Other study ID # VIS-1
Secondary ID
Status Active, not recruiting
Phase N/A
First received July 27, 2017
Last updated August 1, 2017
Start date April 1, 2017
Est. completion date December 1, 2017

Study information
Verified date July 2017
Source Boehringer Labs LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comparing the operation times and staple loads used between the use of multiple tubes and a bougie versus a one-step suction callibrated system in laparoscopic sleeve gastrectomy.

Description:

In this study we are comparing the cost/savings of using a bougie with a one-step suction callibrated system in laparoscopic sleeve gastrectomy. We will be looking at OR time and staple usage. This study is not affecting the treatment of the patients in any way. The surgeons would be using the devices regardless of the study. We are simply looking at procedure information after the fact.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date December 1, 2017
Est. primary completion date December 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Patient and surgeon have both agreed that a sleeve gastrectomy is a procedure that they want performed.

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Suction callibrated system
One-step suction callibrated SG system

Locations
Country Name City State
United States Rochester General Rochester New York

Sponsors (2)
Lead Sponsor Collaborator
Boehringer Labs LLC Rochester General Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Staples Used Number of staple loads needed to close stomach 4 hours for the end of surgery
Primary Operation time Total operation time 4 hours for the end of surgery
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