Indocyanine Green Test in Bariatric Surgery

NCT ID: NCT05476159

Last Updated: 2022-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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Conditions

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Obesity, Morbid Surgery Leak, Anastomotic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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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

Intervention Type DRUG

Gastric bypass

Roux and Y Gastric bypass

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* BMI\>40kg/m2

Exclusion Criteria

* Non obese patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Foggia

OTHER

Sponsor Role lead

Responsible Party

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Giovanna Pavone

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giovanna Pavone

Role: PRINCIPAL_INVESTIGATOR

University of Foggia

Locations

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University of Foggia

Foggia, , Italy

Site Status

Countries

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Italy

References

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Pavone G, Fersini A, Pacilli M, Cianci P, Ambrosi A, Tartaglia N. Anastomotic leak test using indocyanine green during laparoscopic Roux-en-Y gastric bypass: A cohort study. Ann Med Surg (Lond). 2022 Nov 17;84:104939. doi: 10.1016/j.amsu.2022.104939. eCollection 2022 Dec.

Reference Type DERIVED
PMID: 36536736 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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5

Identifier Type: -

Identifier Source: org_study_id

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