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
Irvine, California, United States
ACTIVE_NOT_RECRUITINGKaiser Permanente San Diego medical Center
San Diego, California, United States
RECRUITINGChange 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
Henry Ford Health System
Detroit, Michigan, United States
RECRUITINGLifespan & Brown Surgical Associates
Providence, Rhode Island, United States
ACTIVE_NOT_RECRUITINGUniversity of Utah Health
Salt Lake City, Utah, United States
ACTIVE_NOT_RECRUITINGAsklepios
Hamburg, Germany
RECRUITINGSoroka University Medical Center
Beersheba, Israel
RECRUITINGHumanitas Research Hospital
Milan, Lombardy, Italy
RECRUITINGCHUV
Lausanne, Switzerland
RECRUITING