{
"info": {
"nct_id": "NCT00949273",
"official_title": "A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Cylindrical Abdominoperineal Resection in the Treatment of Advanced Very Low Rectal Cancer",
"inclusion_criteria": "* Tumor within 6 cm of the anal verge, or with very narrow pelvis\n* T3-T4 as determined by preoperative MRI or endorectal ultrasonography examination, or a low tumor is fixed or tethered at rectal examination\n* Absence of distant metastases\n* Absence of intestinal obstruction\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* T1-T2 as determined by preoperative MRI or endorectal ultrasonography examination\n* with distant metastases\n* with intestinal obstruction\n* pregnancy or lactation\n* allergic constitution to heterogeneous protein\n* with operation contraindication\n* with mental disorder",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Tumor within 6 cm of the anal verge, or with very narrow pelvis",
"criterions": [
{
"exact_snippets": "Tumor within 6 cm of the anal verge",
"criterion": "tumor location",
"requirements": [
{
"requirement_type": "distance from anal verge",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "cm"
}
}
]
},
{
"exact_snippets": "very narrow pelvis",
"criterion": "pelvis width",
"requirements": [
{
"requirement_type": "width",
"expected_value": "very narrow"
}
]
}
]
},
{
"line": "* T3-T4 as determined by preoperative MRI or endorectal ultrasonography examination, or a low tumor is fixed or tethered at rectal examination",
"criterions": [
{
"exact_snippets": "T3-T4 as determined by preoperative MRI or endorectal ultrasonography examination",
"criterion": "tumor stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"T3",
"T4"
]
}
]
},
{
"exact_snippets": "a low tumor is fixed or tethered at rectal examination",
"criterion": "tumor fixation",
"requirements": [
{
"requirement_type": "fixation",
"expected_value": true
}
]
}
]
},
{
"line": "* Absence of distant metastases",
"criterions": [
{
"exact_snippets": "Absence of distant metastases",
"criterion": "distant metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Absence of intestinal obstruction",
"criterions": [
{
"exact_snippets": "Absence of intestinal obstruction",
"criterion": "intestinal obstruction",
"requirements": [
{
"requirement_type": "presence",
"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 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* T1-T2 as determined by preoperative MRI or endorectal ultrasonography examination",
"criterions": [
{
"exact_snippets": "T1-T2 as determined by preoperative MRI or endorectal ultrasonography examination",
"criterion": "tumor stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"T1",
"T2"
]
}
]
}
]
},
{
"line": "* with distant metastases",
"criterions": [
{
"exact_snippets": "distant metastases",
"criterion": "metastases",
"requirements": [
{
"requirement_type": "location",
"expected_value": "distant"
}
]
}
]
},
{
"line": "* with intestinal obstruction",
"criterions": [
{
"exact_snippets": "intestinal obstruction",
"criterion": "intestinal obstruction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* pregnancy or lactation",
"criterions": [
{
"exact_snippets": "pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "lactation",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* allergic constitution to heterogeneous protein",
"criterions": [
{
"exact_snippets": "allergic constitution to heterogeneous protein",
"criterion": "allergic constitution",
"requirements": [
{
"requirement_type": "cause",
"expected_value": "heterogeneous protein"
}
]
}
]
},
{
"line": "* with operation contraindication",
"criterions": [
{
"exact_snippets": "operation contraindication",
"criterion": "operation contraindication",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* with mental disorder",
"criterions": [
{
"exact_snippets": "with mental disorder",
"criterion": "mental disorder",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}