Overview
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)
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.
Eligibility
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 One or more of the following six risk factors for postoperative anastomotic leakage6-8 must be true:
- 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 tumours
- Those who received chemo/radiation therapy before surgery
- 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).
④ Those who voluntarily decide to participate in this clinical study, read and
sign the Informed Consent form, and are willing to comply with the study protocol
⑤ Those who have willingness to undertake blood transfusion if required.
Exclusion Criteria:
Patients meeting any of the following Exclusion Criteria will not be eligible to
participate in the study:
- Women who are pregnant or breastfeeding
- Those who receive emergency surgery
- A person who is expected to need intensive medical care after the surgery
due to a serious medical condition, with one or more of the following seven
factors being true:
- Patients with abnormal bone marrow function (those with hemoglobin less
than 10g/dl, leukocyte count less than 4000/mm3, or platelet count less
than 100,000/mm3 even after preoperative corrections)
- Patients with severe liver damage or cirrhosis (those whose AST/ALT
levels are more than three times the normal range or those diagnosed
with cirrhosis)
- Those with abnormal renal function (those who are on hemodialysis or
who have a blood creatinine level of 2.0mg/dl or more before the
surgery)
- Those who have undergone cardiac or cerebrovascular stent procedure
within the last 6 months
- Those who have been diagnosed with pulmonary tuberculosis within the
last 6 months or are undergoing drug treatment for pulmonary
tuberculosis
- Those who continuously administer steroids of 20mg/day or more within
30 days before the surgery
- Patients with ASA (American Society of Anaesthesiologists) score of 3
are evaluated by the investigator who determines whether or not
patients with ASA score of 3 should be enrolled from the patient safety
standpoint. Patients with ASA score higher than 3 are excluded from
this study.
- Patients who are required to undergo re-intervention to treat the
anastomosis following intraoperative positive air leak test (However,
patients who underwent complete reconstruction of the anastomosis in
the presence of a positive air test, which therefore has made their
risk of leak similar to those patients with a negative air leak test.)
- Patients who are immune suppressed
- Patients with severe diverticulosis
- Patients with other colonic wall abnormalities in the likely area of
the Outer Balloon and BT BAND application who may be at increased risk
for device perforation or migration.
④ A person who has difficulty in mobility or is unable to communicate
in general due to a psychiatric/neurologic disorder falling under one
or more of the following:
- Those diagnosed with dementia or Alzheimer's disease.
- Those who have been diagnosed with schizophrenia or depression or are
taking drugs due to this.
- A person who has been diagnosed with disability due to mental
retardation.
- Patients with intestinal perforation, abscess in the pelvis, or
severe inflammation in the pelvis.
- Those who have a history of undergoing major surgeries
(bowel/gastrectomy, hepatectomy, hysterectomy) through
laparotomy and are likely to have serious adhesions that may
affect this surgery.
- A patient who underwent a preoperative chemotherapy, but
the anastomosis is expected to be located very close to
the anus or in the anal canal, thus with a very high
risk for complications of the anastomosis, or a patient
whom the bowel function is expected to decrease
significantly in the future.
- Patients with inflammatory bowel diseases such as
ulcerative colitis, Crohn's disease, intestinal
tuberculosis, or autoimmune diseases such as
Behcet's disease.
⑨ Those who do not consent in writing to the study.
⑩ Blood loss (>750 cc).
⑪ Transfusion during surgery.
⑫ Any new sign of ischemia.
⑬ Diagnosis of bowel obstruction, bowel
strangulation, peritonitis, bowel perforation,
intraabdominal infection, ischemic bowel,
carcinomatosis.
⑭ Exclusion criteria not specified above, but the
patient is determined to be unsuitable for
participation in this clinical study at the
judgment of the researcher.