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NCT05476159 Clinical Trial

Indocyanine Green Test in Bariatric Surgery

Surgery Clinical Trial

Official title:
Anastomotic Leak Test Using Indocyanine Green During Laparoscopic Roux-en-y Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05476159
Other study ID # 5
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2021

Study information
Verified date July 2022
Source University of Foggia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Indocyanine green (ICG) can be injected into the human bloodstream and it allows us to show stomach vascularity in real time

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 31, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - BMI>40kg/m2 Exclusion Criteria: - Non obese patients

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Indocyanine green solution
Adequate perfusion was defined as "the direct and clear visualization of the fluorescence along the gastric tube, relative to the excised specimen, after an estimated time of 150-180 s after i.v. administration injection
Device:
• Gastric bypass
Roux and Y Gastric bypass

Locations
Country Name City State
Italy University of Foggia Foggia

Sponsors (1)
Lead Sponsor Collaborator
University of Foggia

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Positive Intraoperative Indocyanine green test Intraoperative indocyanine green test was performed During surgery (within 150-180 minutes)
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