Prospective Single-center Diagnostic Parallel-group Study to Determine the Minimal Dose of Indocyanine Green to Observe Vascular Perfussion in Revisional Bariatric Surgery.
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of obesity with a BMI ≥ 30 kg/m²
• Scheduled for revisional bariatric surgery
Locations
Other Locations
Mexico
Centro Medico Bariatrico
RECRUITING
Tijuana
Time Frame
Start Date: 2025-05-06
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 108
Treatments
Active_comparator: indocyanine green (5 mg)
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.
Active_comparator: indocyanine green (7.5 mg)
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.
Active_comparator: indocyanine green (10 mg)
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.
Related Therapeutic Areas
Sponsors
Leads: Instituto Mexicano del Seguro Social
Collaborators: Bariatric Medical Center