Bariatric Surgery, Obesity
Conditions
Keywords
bariatric surgery, indocyanine green, vascular, weight loss surgery, Intraoperative Complications, Postoperative Complications
Brief summary
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.
Interventions
DIAGNOSTIC_TESTIndocyanine Green Angiogram
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.
Sponsors
Instituto Mexicano del Seguro Social
Bariatric Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of obesity with a BMI ≥ 30 kg/m² * Scheduled for revisional bariatric surgery
Exclusion criteria
* Allergy to iodides. * Anticoagulation with products containing sodium bisulfite (due to the risk of ICG-FA inactivation). * Use of radioactive iodine studies within the past 7 days. * Pregnant, breastfeeding, or planning to become pregnant within the next year (due to unknown teratogenic or fertility effects of ICG-FA). * History of liver disease or laboratory findings suggestive of moderate to severe hepatic disease: total bilirubin \>1.5 times the upper limit of normal (ULN), or any elevation of aspartate aminotransferase (AST) above ULN. * Participants who withdraw their consent to participate in the study (elimination criterion).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Fluorescence Detection | Intraoperative (within 5 minutes post-injection) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Regional Tissue Perfusion by Anatomical Zone | Intraoperative | 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. |
| Change in Surgical Strategy Based on ICG-FA | Intraoperative | 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. |
| Adverse Events Related to ICG Use | Within 48 hours postoperatively | 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. |
| Postoperative Complications | 30 days postoperatively | Incidence of postoperative complications within 30 days, including anastomotic leak, infection, bleeding, reoperation, or readmission. |
Countries
Mexico
Outcome results
None listed