Anastomotic Leakage, Colorectal Cancer, Colorectal Surgery, Ileostomy - Stoma, Rectal/Anal
Conditions
Keywords
Colorectal Surgery, Colorectal Cancer, Stoma, ileostomy, Anastomotic leakage
Brief summary
The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)
Detailed description
A primary diverting stoma is widely used by surgeons in order to bypass low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which mean that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit. COLO BT™ is a local, temporary bypass device that provides protection of the anastomosis and safely postpones stoma. COLO BT™ is designed to avoid stoma creation in all patients except those patients whose anastomoses have not healed after surgery, allowing the others to return to normal activity more quickly and safely.
Interventions
DEVICECOLO BT™
A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma after surgery for only patients who need it (do not have a healed anastomosis)
OTHERStoma Creation
Protective ileostomy
Sponsors
JSR Medical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
The patient must meet all study Inclusion Criteria as outlined below: * Adult males or females, 19-80 years of age, with signed informed consent * Subject whose anastomosis is expected to be located above 4cm from the anus, and at or below 15cm from the anus. (4cm \< inclusion target ≤ 15cm from the anus). ③ Patient must meet all other inclusion criteria to be eligible. While not required, if one or more of the following six risk factors for postoperative anastomotic leakage\[6,7,8\] is true, the patient will be considered a high-risk subject: \- Male \- Those with a body mass index of 30 or higher \- Current smoker \- Those who are on medication for diabetes \- Those with clinical stage III or higher malignant tumors \- Those who received chemo/radiation therapy before surgery ④ Those who are willing and able to participate in this clinical study, provide Informed Consent, and are willing to comply with the study procedures and follow up evaluations ⑤ Those who have willingness to undertake blood transfusion if required.
Exclusion criteria
Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Success Case(Avoidance of ostomy) | 24 Weeks | Study Success Case" is defined as a case which has met both the "Clinical Success" and "Technical Success" requirements throughout the 24 weeks (6 Months) monitoring period, following the initial surgical treatment with COLO-BT™ or temporary ileostomy |
Countries
United States
Contacts
CONTACTKim
PRINCIPAL_INVESTIGATORMark A Falvo, MD
Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo
Outcome results
None listed