{
"info": {
"nct_id": "NCT02550769",
"official_title": "Multicenter Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Low Anterior Resection in Rectal Cancer",
"inclusion_criteria": "* Age over 18 years\n* Patients with rectal cancer stage: cT1-2-3, cN0-1, cM0.\n* Tumor equal or below 10 cm from the anal verge, candidates to (ETM) low anterior resection and anastomosis, with or without preoperative chemo-radiotherapy.\n* Adenocarcinoma of low or moderate differentiation\n* ASA I, II, III.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Do not sign informed consent\n* Pregnant patients\n* Liver cirrhosis\n* Undifferentiated adenocarcinoma.\n* cT4\n* Metastatic disease (M1)\n* chronic renal failure on dialysis\n* ASA IV\n* BMI <18 and> 35 kg / m2",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age over 18 years",
"criterions": [
{
"exact_snippets": [
"Age over 18 years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">",
"value": 18
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Age over 18 years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">",
"value": 18
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with rectal cancer stage: cT1-2-3, cN0-1, cM0.",
"criterions": [
{
"exact_snippets": [
"rectal cancer"
],
"criterion": "rectal cancer",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"stage: cT1-2-3"
],
"criterion": "cT stage",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1
},
{
"operator": "<=",
"value": 3
}
]
}
},
{
"exact_snippets": [
"cN0-1"
],
"criterion": "cN stage",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0
},
{
"operator": "<=",
"value": 1
}
]
}
},
{
"exact_snippets": [
"cM0"
],
"criterion": "cM stage",
"requirement_type": "value",
"expected_value": "0"
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"rectal cancer"
],
"criterion": "rectal cancer",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"stage: cT1-2-3"
],
"criterion": "cT stage",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1
},
{
"operator": "<=",
"value": 3
}
]
}
},
{
"exact_snippets": [
"cN0-1"
],
"criterion": "cN stage",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0
},
{
"operator": "<=",
"value": 1
}
]
}
},
{
"exact_snippets": [
"cM0"
],
"criterion": "cM stage",
"requirement_type": "value",
"expected_value": "0"
}
]
}
},
{
"identified_line": {
"line": "* Tumor equal or below 10 cm from the anal verge, candidates to (ETM) low anterior resection and anastomosis, with or without preoperative chemo-radiotherapy.",
"criterions": [
{
"exact_snippets": [
"Tumor equal or below 10 cm from the anal verge"
],
"criterion": "tumor distance from anal verge",
"requirement_type": "distance",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 10
}
]
}
},
{
"exact_snippets": [
"candidates to (ETM) low anterior resection and anastomosis"
],
"criterion": "surgical candidacy",
"requirement_type": "procedure",
"expected_value": "(ETM) low anterior resection and anastomosis"
},
{
"exact_snippets": [
"with or without preoperative chemo-radiotherapy"
],
"criterion": "preoperative chemo-radiotherapy",
"requirement_type": "necessity",
"expected_value": [
"with",
"without"
]
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": [
"Tumor equal or below 10 cm from the anal verge"
],
"criterion": "tumor distance from anal verge",
"requirement_type": "distance",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 10
}
]
}
},
{
"exact_snippets": [
"candidates to (ETM) low anterior resection and anastomosis"
],
"criterion": "surgical candidacy",
"requirement_type": "procedure",
"expected_value": "(ETM) low anterior resection and anastomosis"
}
]
},
{
"or_criteria": [
{
"exact_snippets": [
"with or without preoperative chemo-radiotherapy"
],
"criterion": "preoperative chemo-radiotherapy",
"requirement_type": "necessity",
"expected_value": "with"
},
{
"exact_snippets": [
"with or without preoperative chemo-radiotherapy"
],
"criterion": "preoperative chemo-radiotherapy",
"requirement_type": "necessity",
"expected_value": "without"
}
]
}
]
}
},
{
"identified_line": {
"line": "* Adenocarcinoma of low or moderate differentiation",
"criterions": [
{
"exact_snippets": [
"Adenocarcinoma"
],
"criterion": "adenocarcinoma",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"low or moderate differentiation"
],
"criterion": "differentiation",
"requirement_type": "severity",
"expected_value": [
"low",
"moderate"
]
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Adenocarcinoma"
],
"criterion": "adenocarcinoma",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"low or moderate differentiation"
],
"criterion": "differentiation",
"requirement_type": "severity",
"expected_value": [
"low",
"moderate"
]
}
]
}
},
{
"identified_line": {
"line": "* ASA I, II, III.",
"criterions": [
{
"exact_snippets": [
"ASA I, II, III"
],
"criterion": "ASA classification",
"requirement_type": "category",
"expected_value": [
"I",
"II",
"III"
]
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"ASA I, II, III"
],
"criterion": "ASA classification",
"requirement_type": "category",
"expected_value": [
"I",
"II",
"III"
]
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Do not sign informed consent",
"criterions": [
{
"exact_snippets": [
"Do not sign informed consent"
],
"criterion": "informed consent",
"requirement_type": "signed",
"expected_value": false
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Do not sign informed consent"
],
"criterion": "informed consent",
"requirement_type": "signed",
"expected_value": false
}
}
},
{
"identified_line": {
"line": "* Pregnant patients",
"criterions": [
{
"exact_snippets": [
"Pregnant patients"
],
"criterion": "pregnancy",
"requirement_type": "status",
"expected_value": true
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Pregnant patients"
],
"criterion": "pregnancy",
"requirement_type": "status",
"expected_value": true
}
}
},
{
"identified_line": {
"line": "* Liver cirrhosis",
"criterions": [
{
"exact_snippets": [
"Liver cirrhosis"
],
"criterion": "liver cirrhosis",
"requirement_type": "presence",
"expected_value": true
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Liver cirrhosis"
],
"criterion": "liver cirrhosis",
"requirement_type": "presence",
"expected_value": true
}
}
},
{
"identified_line": {
"line": "* Undifferentiated adenocarcinoma.",
"criterions": [
{
"exact_snippets": [
"Undifferentiated adenocarcinoma"
],
"criterion": "adenocarcinoma",
"requirement_type": "differentiation",
"expected_value": "undifferentiated"
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"Undifferentiated adenocarcinoma"
],
"criterion": "adenocarcinoma",
"requirement_type": "differentiation",
"expected_value": "undifferentiated"
}
}
},
{
"identified_line": {
"line": "* cT4",
"criterions": [
{
"exact_snippets": [
"cT4"
],
"criterion": "cT4",
"requirement_type": "presence",
"expected_value": true
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"cT4"
],
"criterion": "cT4",
"requirement_type": "presence",
"expected_value": true
}
}
},
{
"identified_line": {
"line": "* Metastatic disease (M1)",
"criterions": [
{
"exact_snippets": [
"Metastatic disease"
],
"criterion": "metastatic disease",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"M1"
],
"criterion": "metastatic disease",
"requirement_type": "stage",
"expected_value": "M1"
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"Metastatic disease"
],
"criterion": "metastatic disease",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"M1"
],
"criterion": "metastatic disease",
"requirement_type": "stage",
"expected_value": "M1"
}
]
}
},
{
"identified_line": {
"line": "* chronic renal failure on dialysis",
"criterions": [
{
"exact_snippets": [
"chronic renal failure"
],
"criterion": "renal failure",
"requirement_type": "chronicity",
"expected_value": "chronic"
},
{
"exact_snippets": [
"on dialysis"
],
"criterion": "dialysis",
"requirement_type": "treatment",
"expected_value": true
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": [
"chronic renal failure"
],
"criterion": "renal failure",
"requirement_type": "chronicity",
"expected_value": "chronic"
},
{
"exact_snippets": [
"on dialysis"
],
"criterion": "dialysis",
"requirement_type": "treatment",
"expected_value": true
}
]
}
},
{
"identified_line": {
"line": "* ASA IV",
"criterions": [
{
"exact_snippets": [
"ASA IV"
],
"criterion": "ASA classification",
"requirement_type": "classification",
"expected_value": "IV"
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": [
"ASA IV"
],
"criterion": "ASA classification",
"requirement_type": "classification",
"expected_value": "IV"
}
}
},
{
"identified_line": {
"line": "* BMI <18 and> 35 kg / m2",
"criterions": [
{
"exact_snippets": [
"BMI <18"
],
"criterion": "BMI",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18
}
]
}
},
{
"exact_snippets": [
"> 35 kg / m2"
],
"criterion": "BMI",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 35
}
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": [
"BMI <18"
],
"criterion": "BMI",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18
}
]
}
},
{
"exact_snippets": [
"> 35 kg / m2"
],
"criterion": "BMI",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 35
}
]
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}