Safety and Effectiveness Evaluations of the COLO-BT as an Treatment to the Proctectomy.

Eligibility Criteria

• * 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).
• * 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.
• * 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.