Colorectal and Ileorectal Anastomosis
Conditions
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.
Interventions
DEVICETest- Treatment with Sylys Surgical Sealan
Standard closure of stapled anastomosis plus treatment with 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A comparison of the incidence of anastomosis-related complications | from day of surgery to week 26 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A comparison of the proportion of patients who have incidence of sub-clinical or clinical anastomotic leaks | 14 days, 12 weeks, 26 weeks | A comparison of the proportion of patients who have either sub-clinical or clinical anastomotic leaks in each group. |
Countries
Netherlands
Outcome results
None listed