Coloanal and Ileoanal Anastomosis, Colocolic and Ileocolic Anastomosis, Colorectal and Ileorectal Anastomosis
Conditions
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.
Interventions
DEVICESylys® Surgical Sealant
Standard Stapled Anastomosis Colectomy Procedure with the addition of Sylys® Surgical Sealant
PROCEDUREStapled Anastomosis Colectomy Procedure
Standard Stapled Anastomosis Colectomy Procedure without the addition of Sylys® Surgical Sealant
Sponsors
Cohera Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications | 26 Weeks | Number of subjects with anastomosis-related complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sealant Application Evaluation Questionnaire | At time of device application (during surgery) | Questionnaire documenting the ability to apply the sealant adequately to the anastomosis |
| Reduction in Anastomotic Leaks | 26 Weeks | Comparison of anastomotic leak rate across all subjects |
Countries
United States
Outcome results
None listed