Obesity, MorbidNCT05337644
Indocyanine Green Test for Evaluation of Perfusion of Staple Line of the Stomach During Laparoscopic Sleeve Gastrectomy
An observational study of Obesity, Morbid and Diabete Type 2, run by University of Foggia at 1 site in Italy.
Trial summary
The investigators present the case of a 40-year-old female underwent laparoscopic sleeve gastrectomy. Intraoperative indocyanine green test was performed Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, Diabete Type 2, Cardiac Disease
- What is being tested?
- Indocyanine green solution
- Type of treatment
- Injection or infusion
- How many people
- 1 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jan 2022to 25 Mar 2022
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obese patients with BMI >40 kg/m2 underwent laparoscopic Sleeve gastrectomy
Who may be able to join
- BMI >40 kg/m2
Who cannot join
- Non-obese patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leak After Sleeve Gastrectomy With Positive Intraoperative Indocyanine Green Test: Avoidable Scenario?
The investigators present the case of a 40-year-old female underwent laparoscopic sleeve gastrectomy. Intraoperative indocyanine green test was performed
- Conditions
- Obesity, Morbid, Diabete Type 2, Cardiac Disease, Vascular Diseases
- Being tested
- Indocyanine green solution
- Keywords
- laparoscopic Sleeve gastrectomy, Bariatric Surgery, Indocyanine greene test, gastric fistula
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus, Type 2, Heart Diseases, Vascular Diseases, Gastric Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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".
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: from 20 January 2022 to 20 January 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start21 Jan 2022
- Primary completion6 Feb 2022
- Study completion25 Mar 2022
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
- 1 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
- Antonio Ambrosi, Study chair, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337644
- Sponsor's protocol ID
- 4
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35567877
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leak After Sleeve Gastrectomy With Positive Intraoperative Indocyanine Green Test: Avoidable Scenario?
- ClinicalTrials.gov ID
- NCT05337644
- Acronym / sponsor ID
- 4
- Conditions
- Obesity, Morbid, Diabete Type 2, Cardiac Disease, Vascular Diseases
- Keywords
- laparoscopic Sleeve gastrectomy, Bariatric Surgery, Indocyanine greene test, gastric fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 6 Feb 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 20 Apr 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.
The investigators present the case of a 40-year-old female underwent laparoscopic sleeve gastrectomy. Intraoperative indocyanine green test was performed
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients with BMI >40 kg/m2 underwent laparoscopic Sleeve gastrectomy
Key inclusion criteria (1 listed)
- BMI >40 kg/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 solution5 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". | Drug | – |
Primary outcome
Positive Intraoperative Indocyanine green test
Time frame: from 20 January 2022 to 20 January 2022
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 20 Apr 2022.
- Derived from this study: PubMed 35567877Pavone 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.
- 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.
Antonio Ambrosi study chair
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 Diabete Type 2, 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 20 Apr 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: from 20 January 2022 to 20 January 2022). 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 NCT05337644, 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 20 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.