Protocol updates resulted in new protocol/study

The Cohera Sylys® Surgical Sealant study is a pivotal, prospective, randomized, controlled, multicenter superiority clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) during stapled colorectal and ileorectal anastomosis procedures.

Inclusion Criteria:

• Be at least 22 years of age
• Be scheduled for a stapled colorectal or ileorectal anastomosis procedure with or without diverting stoma
• Agree to return for all follow-up evaluations and procedures specified in the protocol
• Understand and give informed consent

Exclusion Criteria:

• Albumin < 3
• ASA ≥ 4
• Neutropenia ≤ 800
• Pregnancy
• The following conditions involving compromised immune system: AIDS (HIV positive not excluded), neutropenia
• Known blood clotting disorder requiring treatment
• Any condition known to effect wound healing, such as collagen vascular disease
• Have known or suspected allergy or sensitivity to any test materials or reagents
• Concurrent use of fibrin sealants or other anastomosis care devices
• Surgery for emergency abdominal indications
• Has undergone a colorectal anastomosis procedure in the previous two months
• Has an emergent infection related to a previous colorectal anastomosis procedure
• Is scheduled to undergo a Hartmann's procedure
• Is scheduled to undergo trans-anal endoscopic microsurgery (TEM) Is participating in another medical device trial related to colorectal anastomosis