Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy

Prior treatment

• Those who receive emergency 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 who had pre-operative radiotherapy should be excluded.
• Experienced blood loss (\>750 cc) within 6 weeks before randomization.
• Transfusion during surgery.
• Any new sign of ischemia within 6 weeks before randomization.
• Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel all due to carcinomatosis within 6 weeks before randomization.

Other illness

• 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 intellectual disability.
• Patients with intestinal perforation, abscess in the pelvis, or severe inflammation in the pelvis.
• Those who have a history of undergoing major surgeries (major bowel resection/major gastrectomy, major hepatectomy) through laparotomy and are likely to have serious adhesions that may affect this surgery.
• Patients with inflammatory bowel diseases such as ulcerative colitis, Crohn's disease, intestinal tuberculosis, or autoimmune diseases such as Bechet's disease.
• Known hypersensitivity or allergy to any of the components required for the procedure.

Lab values

• 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 7g/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 Anesthesiologists) 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.

Other

• 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 do not consent in writing to the study.
• 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.

• 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.