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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Colorectal and Ileorectal Anastomosis

Intervention / Treatment
-----------------
* Device: Test- Treatment with Sylys Surgical Sealan


Participation Criteria
=================
Eligibility Criteria
-----------------
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

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- Treatment with Sylys Surgical Sealant<br>Standard closure plus treatment with Sylys Surgical Sealant | Device: Test- Treatment with Sylys Surgical Sealan<br>* Standard closure of stapled anastomosis plus treatment with Sylys Surgical Sealant<br>|
| No Intervention: Control- Standard of Care<br>Control group is standard closure of anastomosis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A comparison of the incidence of anastomosis-related complications |  | from day of surgery to week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A comparison of the proportion of patients who have incidence of sub-clinical or clinical anastomotic leaks | A comparison of the proportion of patients who have either sub-clinical or clinical anastomotic leaks in each group. | 14 days, 12 weeks, 26 weeks |