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NCT05337644 Clinical Trial

Indocyanine Green Test for Evaluation of Perfusion of Staple Line of the Stomach During Laparoscopic Sleeve Gastrectomy

Obesity, Morbid Clinical Trial

Official title:
Leak After Sleeve Gastrectomy With Positive Intraoperative Indocyanine Green Test: Avoidable Scenario?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05337644
Other study ID # 4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 21, 2022
Est. completion date March 25, 2022

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

Clinical Trial Summary

The investigators present the case of a 40-year-old female underwent laparoscopic sleeve gastrectomy. Intraoperative indocyanine green test was performed

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date March 25, 2022
Est. primary completion date February 6, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - BMI >40 kg/m2 Exclusion Criteria: - Non-obese patients

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Indocyanine green solution
5 ml of ICG were then injected intravenously to identify the stomach, carefully assessing the angle of His (preoperative written informed consent was obtained from the patient). Adequate perfusion was defined as "the direct and clear visualization of the fluorescence around the gastric tube, after an estimated time of 150-180 s followingi.v. administration".

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 from 20 January 2022 to 20 January 2022
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