NCT05476159

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

1.8 years

First QC Date

July 23, 2022

Last Update Submit

July 25, 2022

Conditions

Obesity, MorbidSurgeryLeak, Anastomotic

Outcome Measures

Primary Outcomes (1)

  • Positive Intraoperative Indocyanine green test

    Intraoperative indocyanine green test was performed

    During surgery (within 150-180 minutes)

Interventions

Indocyanine green solutionDRUG

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

Gastric bypassDEVICE

Roux and Y Gastric bypass

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The aim of our study is to observe the preliminary results of the application of indocyanine green fluorescence (IGF) during laparoscopic Roux-en-Y Gastric Bypass (RYGB in our center and how the perfusion of the gastro-jejunal anastomosis affects the onset of fistula.

You may qualify if:

  • BMI\>40kg/m2

You may not qualify if:

  • Non obese patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Foggia

Foggia, 71122, Italy

Location

Related Publications (1)

  • 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.

    PMID: 36536736DERIVED

MeSH Terms

Conditions

Obesity, MorbidAnastomotic Leak

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Giovanna Pavone

    University of Foggia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

July 23, 2022

First Posted

July 27, 2022

Study Start

January 1, 2020

Primary Completion

November 1, 2021

Study Completion

December 31, 2021

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)