Obesity, MorbidNCT05476159
Indocyanine Green Test in Bariatric Surgery
An observational study of Obesity, Morbid and Surgery, run by University of Foggia at 1 site in Italy.
Trial summary
Indocyanine green (ICG) can be injected into the human bloodstream and it allows us to show stomach vascularity in real time Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, Surgery, Leak, Anastomotic
- What is being tested?
- Indocyanine green solution and Gastric bypass
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- BMI>40kg/m2
Who cannot join
- Non obese patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anastomotic Leak Test Using Indocyanine Green During Laparoscopic Roux-en-y Gastric Bypass
Indocyanine green (ICG) can be injected into the human bloodstream and it allows us to show stomach vascularity in real time
- Conditions
- Obesity, Morbid, Surgery, Leak, Anastomotic
- Being tested
- Indocyanine green solution, Gastric bypass
- Medical subject headings
- Obesity, Morbid, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Intraoperative Indocyanine green test
Intraoperative indocyanine green test was performed
Measured: During surgery (within 150-180 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Jan 2020
- Primary completion1 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanna Pavone, University of Foggia
- Investigators
- Giovanna Pavone, Principal investigator, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476159
- Sponsor's protocol ID
- 5
- Status last verified
- Jul 2022
- First submitted
- 23 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36536736
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anastomotic Leak Test Using Indocyanine Green During Laparoscopic Roux-en-y Gastric Bypass
- ClinicalTrials.gov ID
- NCT05476159
- Acronym / sponsor ID
- 5
- Conditions
- Obesity, Morbid, Surgery, Leak, Anastomotic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Indocyanine green (ICG) can be injected into the human bloodstream and it allows us to show stomach vascularity in real time
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- BMI>40kg/m2
Key exclusion criteria (1 listed)
- Non obese patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine green solutionAdequate 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 | Drug | – |
| Gastric bypassRoux and Y Gastric bypass | Device | – |
Primary outcome
Positive Intraoperative Indocyanine green test
Time frame: During surgery (within 150-180 minutes)
Intraoperative indocyanine green test was performed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 36536736Pavone 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanna Pavone principal investigator
University of Foggia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Surgery, run by University of Foggia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Intraoperative Indocyanine green test (time frame: During surgery (within 150-180 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05476159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.