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| Name | Class |
|---|---|
| Bariatric Medical Center | UNKNOWN |
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This study will compare different doses of a green fluorescent product that is administered during weight loss surgery in order to observe where blood vessels are located. There is uncertainty around the optimal dose of this product for patients with obesity, so this study will aim to study if the dose in the minimal range recommended by international guidelines is sufficient for most patients or if higher doses are needed with increasing body mass index.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| indocyanine green (5 mg) | Active Comparator | Participants in this arm will receive a single 5 mg intravenous dose of indocyanine green (ICG) during surgery, diluted in 10 mL of sterile saline, followed by a 20 mL saline flush. ICG angiography will be performed using a near-infrared (NIR) fluorescence imaging system (Stryker® 1688 4K laparoscopic camera or da Vinci Xi Firefly®). Imaging will begin immediately before ICG administration and will include a minimal 120 seconds focused on the pouch or duodenal area and the anastomosis. The camera will be positioned at a fixed 5 cm distance and 30° angle. All other surgical procedures will be conducted according to standard of care. |
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| indocyanine green (7.5 mg) | Active Comparator | Participants in this arm will receive a single 7.5 mg intravenous dose of indocyanine green (ICG) during surgery, diluted in 10 mL of sterile saline, followed by a 20 mL saline flush. ICG angiography will be performed using a near-infrared (NIR) fluorescence imaging system (Stryker® 1688 4K laparoscopic camera or da Vinci Xi Firefly®). Imaging will begin immediately before ICG administration and will include a minimal 120 seconds focused on the pouch or duodenal area and the anastomosis. The camera will be positioned at a fixed 5 cm distance and 30° angle. All other surgical procedures will be conducted according to standard of care. |
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| indocyanine green (10 mg) | Active Comparator | Participants in this arm will receive a single 10 mg intravenous dose of indocyanine green (ICG) during surgery, diluted in 10 mL of sterile saline, followed by a 20 mL saline flush. ICG angiography will be performed using a near-infrared (NIR) fluorescence imaging system (Stryker® 1688 4K laparoscopic camera or da Vinci Xi Firefly®). Imaging will begin immediately before ICG administration and will include a minimal 120 seconds focused on the pouch or duodenal area and the anastomosis. The camera will be positioned at a fixed 5 cm distance and 30° angle. All other surgical procedures will be conducted according to standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green Angiogram | Diagnostic Test | Three different doses of indocyanin green will be compared (5 mg, 7.5 mg, and 10 mg). These doses are within the range of currently recommended doses by the International Society for Fluorescence Guided Surgery (ISFGS) for bariatric surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Fluorescence Detection | Time (in seconds) from intravenous injection of indocyanine green (ICG) to the first visual detection of fluorescence in the surgical field, as captured using near-infrared fluorescence imaging. Assessed at four time points (30s, 60s, 90s, 120s) post-injection. Timing will be standardized from injection to image capture. Time point of first visible fluorescence will be recorded by blinded assessors. | Intraoperative (within 5 minutes post-injection) |
| Measure | Description | Time Frame |
|---|---|---|
| Regional Tissue Perfusion by Anatomical Zone | Fluorescence signal intensity and timing will be recorded for predefined anatomical zones based on vascular supply in the gastric pouch and duodenal stump. Zones are classified as Zone 1 (proximal/cardial), Zone 2 (mid/corporal), Zone 3 (distal/anastomotic) for the pouch, and Zone 1 (pyloric transition), Zone 2 (suprapancreatic duodenum), and Zone 3 (distal duodenum) for the duodenum. Signal quality will be scored (e.g., adequate/inadequate) and recorded for each zone. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Medico Bariatrico | Recruiting | Tijuana | Estado de Baja California | 22046 | Mexico |
Anonymized individual participant data will be deposited and made available through an open acess data repository (i.e., Harvard Dataverse). Any potentially sensitive patient-identifying data will either not be released or will undergo minimization and aggregation/abstraction procedures to reduce participant identification risk. Informed consent forms will indicate that a minimal risk of re-identification cannot be excluded despite all these participant data protection methods, in compliance with current IPD sharing recommendations.
IPD and supporting information will be made available with the final original research article, which will be made available as a preprint within a maximum 1-year term after the study conclusion date. This report will be subsequently sent for publication in a peer-reviewed journal. Other pre-specified outcomes may be reported in separate publication after the main research article, reason why the indicated time frame does not apply for such outcomes. There i
No data and supporting information access restrictions are anticipated, as these will be deposited in open access repositories (i.e., Harvard Dataverse, Open Science Framework, Zenodo).
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Group assignment is centrally managed. Participants are blinded under anesthesia, with no awareness of group assignment. The anesthesiologist knows the dose but is blinded to outcomes and conceals the dose from surgeons. Data collectors and laboratory technicians are not informed of group assignment or study purpose. Adjudicators of outcomes, not involved in surgery, will assess postoperative videos blinded to patient characteristics and knowing only the timing of drug administration. Data analysts and the data safety monitoring committee use coded identifiers to remain blinded to group assignments. The manuscript's results will be written blinded, after which codes will be replaced for actual doses to interpret and discuss the findings.
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| Intraoperative |
| Change in Surgical Strategy Based on ICG-FA | Proportion of cases in which surgical plans were modified intraoperatively (e.g., change in site of anastomosis, reinforcement, or tissue resection) based on ICG perfusion findings. | Intraoperative |
| Adverse Events Related to ICG Use | Number and type of adverse events related to ICG administration, including allergic reactions (e.g., rash, anaphylaxis) or abnormal elevations in liver enzymes (AST, ALT, bilirubin) postoperatively. | Within 48 hours postoperatively |
| Postoperative Complications | Incidence of postoperative complications within 30 days, including anastomotic leak, infection, bleeding, reoperation, or readmission. | 30 days postoperatively |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |