{
"info": {
"nct_id": "NCT03724591",
"official_title": "A Randomized Controlled Clinical Trial to Investigate the Effects of Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer",
"inclusion_criteria": "* Patients suitable for curative surgery over 18 years old;\n* American Society of Anesthesiologists(ASA) grade I-III;\n* Pathological diagnosis of rectal adenocarcinoma;\n* Patients suitable for abdominalperineal resection\n* Informed consent;\n* No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
"exclusion_criteria": "* Pregnant patient;\n* History of psychiatric disease;\n* Use of systemic steroids;\n* Simultaneous multiple primary colorectal cancer;\n* Preoperative imaging examination results show:1. Tumor involves the surrounding organs and combined organ resection need to be done;2. distant metastasis;3. unable to perform R0 resection;\n* History of any other malignant tumor in recent 5 years;\n* Patients need emergency operation: mechanic ileus, perforation.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Patients suitable for curative surgery over 18 years old;",
"criterions": [
{
"exact_snippets": "Patients suitable for curative surgery",
"criterion": "suitability for curative surgery",
"requirements": [
{
"requirement_type": "suitability",
"expected_value": true
}
]
},
{
"exact_snippets": "over 18 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* American Society of Anesthesiologists(ASA) grade I-III;",
"criterions": [
{
"exact_snippets": "American Society of Anesthesiologists(ASA) grade I-III",
"criterion": "ASA grade",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Pathological diagnosis of rectal adenocarcinoma;",
"criterions": [
{
"exact_snippets": "Pathological diagnosis of rectal adenocarcinoma",
"criterion": "rectal adenocarcinoma",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients suitable for abdominalperineal resection",
"criterions": [
{
"exact_snippets": "Patients suitable for abdominalperineal resection",
"criterion": "suitability for abdominalperineal resection",
"requirements": [
{
"requirement_type": "suitability",
"expected_value": true
}
]
}
]
},
{
"line": "* Informed consent;",
"criterions": [
{
"exact_snippets": "Informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.",
"criterions": [
{
"exact_snippets": "No history of familial adenomatous polyposis",
"criterion": "familial adenomatous polyposis",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
},
{
"exact_snippets": "No history of ... ulcerative colitis",
"criterion": "ulcerative colitis",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
},
{
"exact_snippets": "No history of ... Crohn's disease",
"criterion": "Crohn's disease",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
}
]
},
{
"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 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 85 Years",
"criterions": [
{
"exact_snippets": "maximum age of 85 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 85,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Pregnant patient;",
"criterions": [
{
"exact_snippets": "Pregnant patient",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* History of psychiatric disease;",
"criterions": [
{
"exact_snippets": "History of psychiatric disease",
"criterion": "psychiatric disease",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Use of systemic steroids;",
"criterions": [
{
"exact_snippets": "Use of systemic steroids",
"criterion": "systemic steroid use",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Simultaneous multiple primary colorectal cancer;",
"criterions": [
{
"exact_snippets": "Simultaneous multiple primary colorectal cancer",
"criterion": "multiple primary colorectal cancer",
"requirements": [
{
"requirement_type": "simultaneity",
"expected_value": true
}
]
}
]
},
{
"line": "* Preoperative imaging examination results show:1. Tumor involves the surrounding organs and combined organ resection need to be done;2. distant metastasis;3. unable to perform R0 resection;",
"criterions": [
{
"exact_snippets": "Tumor involves the surrounding organs",
"criterion": "tumor involvement",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "surrounding organs"
}
]
},
{
"exact_snippets": "distant metastasis",
"criterion": "distant metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "unable to perform R0 resection",
"criterion": "R0 resection",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "* History of any other malignant tumor in recent 5 years;",
"criterions": [
{
"exact_snippets": "History of any other malignant tumor in recent 5 years",
"criterion": "malignant tumor",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Patients need emergency operation: mechanic ileus, perforation.",
"criterions": [
{
"exact_snippets": "emergency operation: mechanic ileus",
"criterion": "emergency operation",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "mechanic ileus"
}
]
},
{
"exact_snippets": "emergency operation: ... perforation",
"criterion": "emergency operation",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "perforation"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}