Active — Not RecruitingPhase 4

The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery.

Canada300 participantsStarted 2023-01-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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. Exclusion Criteria: * Not willing to participate in study * Contraindication to, or not planned to undergo RYGB * Known allergy to indocyanine green or Sodium Iodide * Is participant pregnant or planning to get pregnant in next two years * Ongoing substance abuse or active smoking * Bleeding diathesis or Coagulopathy * Unwilling to take PPI medication Post operatively

What they're measuring

The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery.

Timeframe: 2 years

Trial details

NCT IDNCT06002906

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-03

View on ClinicalTrials.gov More Ulcer, Gastric trials