Efficacy and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized Trial
Details
In this study, Colospan is investigating the use of the CG-100 Intraluminal Bypass Device as a treatment option that could protect the anastomotic site from faecal contact in order to give the site time to heal (approximately 10 days) in order to prevent anastomotic leaks. One benefit of the CG-100 Intraluminal Bypass Device is that it may reduce the occurrence of unnecessary diverting stoma procedures. The CG-100 Intraluminal Bypass Device is a single use, removable, temporary tube that is placed inside the colon and through the anastomosis during the colorectal surgery. The device was developed by Colospan and is intended to allow faecal material pass over the anastomosis site without contact.
Eligibility
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Eligibility Criteria:
Inclusion Criteria (Preoperative):
Patients must be 22-70 years of age and diagnosed with colorectal cancer.
Patient is scheduled for elective open, laparoscopic, or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis.
Patients who are scheduled to receive a protective stoma during their primary planned operation.
Exclusion Criteria (Preoperative):
Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, or extensively spread inflammatory bowel disease.
Patient has been taking regular systemic/steroid medication in the last 6 months.
Pregnant or nursing female patients. Female patients of child-bearing potential must have negative pregnancy test done within 7 days.