A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Today a stoma is created for all high-risk patients even though the expected anastomotic leak rate is less than 20%. This means that 80% of patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit. CG-100, a removable, temporary intraluminal bypass device, developed by Colospan, is designed to address this need by safely postponing the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis); thereby allowing patients with an intact anastomosis a quicker and safer return to normal activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
250
a removable, temporary intraluminal bypass device, developed by Colospan, is designed to safely postpone the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis)
Primary protective ileostomy
University of California Irvine
Orange, California, United States
RECRUITINGKaiser Permanente San Diego medical Center
San Diego, California, United States
Change in Stoma creation rate
Time frame: 39 Weeks
Incidence of complications
Time frame: 39 Weeks
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Colorado University Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGUniversity of Louisville
Louisville, Kentucky, United States
ACTIVE_NOT_RECRUITINGHenry Ford Health System
Detroit, Michigan, United States
ACTIVE_NOT_RECRUITINGEast Bank Hospital - M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
ACTIVE_NOT_RECRUITINGNew York-Presbyterian / Weill Cornell Medical Center
New York, New York, United States
ACTIVE_NOT_RECRUITINGJefferson University Hospital
Philadelphia, Pennsylvania, United States
ACTIVE_NOT_RECRUITINGLifespan & Brown Surgical Associates
Providence, Rhode Island, United States
ACTIVE_NOT_RECRUITINGUniversity of Utah Health
Salt Lake City, Utah, United States
ACTIVE_NOT_RECRUITING...and 4 more locations