| 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).
? 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
? 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
? 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.
? 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.
? Those who do not consent in writing to the study.
? Blood loss (>750 cc).
? Transfusion during surgery.
? Any new sign of ischemia.
? Diagnosis of bowel obstruction, bowel
strangulation, peritonitis, bowel perforation,
intraabdominal infection, ischemic bowel,
carcinomatosis.
? 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.
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