NCT05337644

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

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 21, 2022

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

16 days

First QC Date

March 30, 2022

Last Update Submit

April 14, 2022

Conditions

Obesity, MorbidDiabete Type 2Cardiac DiseaseVascular Diseases

Keywords

laparoscopic Sleeve gastrectomyBariatric SurgeryIndocyanine greene testgastric fistula

Outcome Measures

Primary Outcomes (1)

  • Positive Intraoperative Indocyanine green test

    Intraoperative indocyanine green test was performed

    from 20 January 2022 to 20 January 2022

Interventions

Indocyanine green solutionDRUG

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".

Eligibility Criteria

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

Obese patients with BMI \>40 kg/m2 underwent laparoscopic Sleeve gastrectomy

You may qualify if:

  • BMI \>40 kg/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, Tartaglia N, Pacilli M, Maddalena F, Petruzzelli F, Ambrosi A. Leak after sleeve gastrectomy with positive intraoperative indocyanine green test: Avoidable scenario? Int J Surg Case Rep. 2022 Jun;95:107168. doi: 10.1016/j.ijscr.2022.107168. Epub 2022 May 6.

    PMID: 35567877DERIVED

MeSH Terms

Conditions

Obesity, MorbidDiabetes Mellitus, Type 2Heart DiseasesVascular DiseasesGastric Fistula

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesCardiovascular DiseasesDigestive System FistulaDigestive System DiseasesFistulaPathological Conditions, Anatomical

Study Officials

  • Antonio Ambrosi

    University of Foggia

    STUDY CHAIR

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

March 30, 2022

First Posted

April 20, 2022

Study Start

January 21, 2022

Primary Completion

February 6, 2022

Study Completion

March 25, 2022

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)