{
"info": {
"nct_id": "NCT02426762",
"official_title": "Use of a Quick Skin Sealant in Prevention of Surgical Site Infection After Laparoscopic Tumor Resection",
"inclusion_criteria": "* The informed consent has been obtained from the patient.\n* With confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor, inflammatory bowel disease and diverticula.\n* Endurable laparoscopic surgery without conversion.\n* With moderate/good ECOG health rating (PS): 0-1 score.\nHealthy volunteers allowed\nMust have minimum age of 16 Years\nMust have maximum age of 65 Years",
"exclusion_criteria": "* Pregnant woman or lactating woman.\n* With confirmed distant metastasis in liver, lung, bones, or other organs.\n* Intolerable laparoscopic operation or converted to open surgery.\n* With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.\n* With bad compliance or contraindication to enrollment.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* The informed consent has been obtained from the patient.",
"criterions": [
{
"exact_snippets": "informed consent has been obtained",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "obtained",
"expected_value": true
}
]
}
]
},
{
"line": "* Endurable laparoscopic surgery without conversion.",
"criterions": [
{
"exact_snippets": "Endurable laparoscopic surgery without conversion.",
"criterion": "laparoscopic surgery",
"requirements": [
{
"requirement_type": "endurance",
"expected_value": true
},
{
"requirement_type": "conversion",
"expected_value": false
}
]
}
]
},
{
"line": "* With moderate/good ECOG health rating (PS): 0-1 score.",
"criterions": [
{
"exact_snippets": "ECOG health rating (PS): 0-1 score",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "score",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "score"
},
{
"operator": "<=",
"value": 1,
"unit": "score"
}
]
}
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 16 Years",
"criterions": [
{
"exact_snippets": "minimum age of 16 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 16,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 65 Years",
"criterions": [
{
"exact_snippets": "maximum age of 65 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 65,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Pregnant woman or lactating woman.",
"criterions": [
{
"exact_snippets": "Pregnant woman",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "lactating woman",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Intolerable laparoscopic operation or converted to open surgery.",
"criterions": [
{
"exact_snippets": "Intolerable laparoscopic operation",
"criterion": "laparoscopic operation",
"requirements": [
{
"requirement_type": "tolerance",
"expected_value": false
}
]
},
{
"exact_snippets": "converted to open surgery",
"criterion": "conversion to open surgery",
"requirements": [
{
"requirement_type": "occurrence",
"expected_value": true
}
]
}
]
},
{
"line": "* With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.",
"criterions": [
{
"exact_snippets": "severe comorbidities, such as cardiovascular disease",
"criterion": "cardiovascular disease",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
}
]
},
{
"exact_snippets": "severe comorbidities, such as ... chronic obstructive pulmonary disease",
"criterion": "chronic obstructive pulmonary disease",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
}
]
},
{
"exact_snippets": "severe comorbidities, such as ... diabetes mellitus",
"criterion": "diabetes mellitus",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
}
]
},
{
"exact_snippets": "severe comorbidities, such as ... chronic renal dysfunction",
"criterion": "chronic renal dysfunction",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
}
]
}
]
},
{
"line": "* With bad compliance or contraindication to enrollment.",
"criterions": [
{
"exact_snippets": "bad compliance",
"criterion": "compliance",
"requirements": [
{
"requirement_type": "quality",
"expected_value": "good"
}
]
},
{
"exact_snippets": "contraindication to enrollment",
"criterion": "contraindication to enrollment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "* With confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor, inflammatory bowel disease and diverticula.",
"criterions": [
{
"exact_snippets": "confirmed diagnosis of gastric cancer",
"criterion": "gastric cancer",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": "confirmed"
}
]
},
{
"exact_snippets": "confirmed diagnosis of colorectal cancer",
"criterion": "colorectal cancer",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": "confirmed"
}
]
},
{
"exact_snippets": "confirmed diagnosis of gastrointestinal stromal tumor",
"criterion": "gastrointestinal stromal tumor",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": "confirmed"
}
]
},
{
"exact_snippets": "confirmed diagnosis of inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": "confirmed"
}
]
},
{
"exact_snippets": "confirmed diagnosis of diverticula",
"criterion": "diverticula",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": "confirmed"
}
]
}
]
}
],
"failed_exclusion": [
{
"line": "* With confirmed distant metastasis in liver, lung, bones, or other organs.",
"criterions": [
{
"exact_snippets": "confirmed distant metastasis in liver",
"criterion": "distant metastasis in liver",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "confirmed distant metastasis in lung",
"criterion": "distant metastasis in lung",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "confirmed distant metastasis in bones",
"criterion": "distant metastasis in bones",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "confirmed distant metastasis in ... other organs",
"criterion": "distant metastasis in other organs",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"failed_miscellaneous": []
}