A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant

Study Overview
=================
Brief Summary
-----------------
The Cohera Sylys® Surgical Sealant study is a prospective, randomized, controlled, multicenter clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) in patients undergoing a colectomy procedure with a stapled anastomosis.

Official Title
-----------------
A Prospective, Randomized, Controlled, Multicenter Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant

Conditions
-----------------
Colorectal and Ileorectal Anastomosis, Colocolic and Ileocolic Anastomosis, Coloanal and Ileoanal Anastomosis

Intervention / Treatment
-----------------
* Device: Sylys® Surgical Sealant
* Procedure: Stapled Anastomosis Colectomy Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 22 years of age or older Be scheduled for a colectomy procedure with a stapled anastomosis At time of surgery, has a completed anastomosis that is able to be visualized and is accessible to allow for circumferential sealant application with minimal bowel manipulation (≥90%) Completed anastomosis must be at a location where a WCE can be performed to evaluate for a sub-clinical leak Agree to return for all follow-up evaluations and procedures specified in the protocol Understand and give informed consent Exclusion Criteria: Albumin < 3 g/dL ASA score (American Society of Anesthesiologists) ≥ 4 Neutropenia ≤ 800 cells/µl Pregnant at time of surgery Has AIDS (HIV positive not excluded) Has neutropenia (IBD and steroid use not excluded) Has a known blood clotting disorder requiring treatment Has any condition known to effect wound healing, such as collagen vascular disease Has known or suspected allergy or sensitivity to any test materials, reagents, or WCE contrast materials Has undergone chemotherapy within 4 weeks of the anastomosis procedure and/or radiation within 3 days of the anastomosis procedure Concurrently using fibrin sealants or other anastomosis care devices Emergency surgery for abdominal indications Has undergone a colectomy procedure in the previous two months Has an emergent infection related to a previous colectomy procedure Is scheduled to undergo a Hartmann's procedure Is scheduled to undergo trans-anal endoscopic microsurgery (TEM) Is scheduled to undergo procedure using omental wrapping Is participating in another medical device trial involving colectomy with anastomosis First 20 subjects ONLY: • Is diagnosed with high risk cancer as determined by preoperative clinical evidence or diagnostic imaging (if patient's cancer stage has been downstaged through treatment prior to baseline screening, subject is allowed to be included): Lymph Node Cancer Stage: N2 Cancer Tumor Size: T4 Circumferential resection margin: CRM+ (Positive)

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Test group will receive Sylys® Surgical Sealant as an adjunct to standard closure of stapled anastomosis in colectomy procedure. | Device: Sylys® Surgical Sealant<br>* Standard Stapled Anastomosis Colectomy Procedure with the addition of Sylys® Surgical Sealant<br>|
| Active Comparator: Control<br>Control group will receive standard of care closure of stapled anastomosis in colectomy procedure without Sylys® Surgical Sealant. | Procedure: Stapled Anastomosis Colectomy Procedure<br>* Standard Stapled Anastomosis Colectomy Procedure without the addition of Sylys® Surgical Sealant<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications | Number of subjects with anastomosis-related complications | 26 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sealant Application Evaluation Questionnaire | Questionnaire documenting the ability to apply the sealant adequately to the anastomosis | At time of device application (during surgery) | 
| Reduction in Anastomotic Leaks | Comparison of anastomotic leak rate across all subjects | 26 Weeks |