The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery
Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This is an interventional pilot study aimed to evaluate the use of NIF imaging as an intraoperative aid to assess the anastomotic blood flow to the gastric pouch and gastrojejunostomy during Roux-en-Y gastric bypass surgery and to determine its long-term impact on the rate of marginal ulceration, leaks and stricture.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Capacity to provide informed consent.
• Over the Age of 18.
• Eligible for bariatric surgery in Ontario and deemed an appropriate candidate for RYGB surgery by the bariatric program.
• Commit to follow-up within the bariatric program, including behavioral and dietary modifications designed to aid in sustained weight-loss.
• Treatment of marginal ulcer with the revisional surgery.
Locations
Other Locations
Canada
Toronto Western Hospital, University Health Network
RECRUITING
Toronto
Contact Information
Primary
Allan Okrainec, MDCM, MHPE
allan.okrainec@uhn.ca
4166035224
Backup
Priya Sharma
priya.sharma@uhn.ca
Time Frame
Start Date: 2023-01-25
Estimated Completion Date: 2027-06
Participants
Target number of participants: 300
Treatments
Experimental: Interventional group (with drug)
The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto
Collaborators: Stryker Endoscopy