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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
61
Standard closure of stapled anastomosis plus treatment with Sylys Surgical Sealant
Flevoziekenhuis
Almere Stad, Flevoland, Netherlands
Meander Medical Center
Amersfoort, Netherlands
OLVG
Amsterdam, Netherlands
AMC
Amsterdam-Zuidoost, Netherlands
Laurentius
A comparison of the incidence of anastomosis-related complications
Time frame: from day of surgery to week 26
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.
Time frame: 14 days, 12 weeks, 26 weeks
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Roermond, Netherlands
Diakonessenhuis
Utrecht, Netherlands