{
"info": {
"nct_id": "NCT05495048",
"official_title": "Transvaginal Natural Orifice Specimen Extraction Surgery Versus Conventional Laparoscopic Surgery With Mini-laparotomy in Right Hemicolectomy for Colon Cancer: a Randomised, Controlled, Phase 3, Non-inferiority Trial (NOSES VIIIA Trial)",
"inclusion_criteria": "* volunteer to participate and the informed consent signed;\n* 18-75 years;\n* female who have given birth;\n* pathologically confirmed adenocarcinoma/high-grade intraepithelial neoplasia by preoperative colonoscopy and biopsy;\n* preoperative CT or MRI indicates that the tumor diameter is no more than 5.0 cm;\n* preoperative staging cT1-3NanyM0\n* body mass index <30 kg/m2;\n* willing to undergo laparoscopic right hemicolectomy\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* contraindications for laparoscopic surgery;\n* emergency surgery due to acute intestinal obstruction, perforation or bleeding;\n* distant metastasis;\n* multiple colorectal cancer;\n* has received preoperative chemoradiotherapy;\n* with a history of other malignant tumors;\n* unwilling to sign the informed consent or receive follow-up according to the study protocol.",
"miscellaneous_criteria": ""
},
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"line": "* volunteer to participate and the informed consent signed;",
"criterions": [
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]
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},
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"line": "* 18-75 years;",
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}
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}
},
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},
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}
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"requirement": {
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}
},
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"expected_value": "pathologically confirmed"
}
},
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}
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},
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},
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}
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"unit": "cm"
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}
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},
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"requirement": {
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"operator": ">=",
"value": 1,
"unit": "T"
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"unit": "T"
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}
},
{
"exact_snippets": "preoperative staging ... Nany",
"criterion": "lymph node involvement",
"requirement": {
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"expected_value": "any"
}
},
{
"exact_snippets": "preoperative staging ... M0",
"criterion": "distant metastasis",
"requirement": {
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"expected_value": {
"operator": "=",
"value": 0,
"unit": "M"
}
}
}
]
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"unit": "T"
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"value": 0,
"unit": "M"
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}
},
{
"identified_line": {
"line": "* body mass index <30 kg/m2;",
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"unit": "kg/m2"
}
}
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"unit": "kg/m2"
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},
{
"identified_line": {
"line": "* willing to undergo laparoscopic right hemicolectomy",
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"exact_snippets": "willing to undergo laparoscopic right hemicolectomy",
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"requirement": {
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"expected_value": true
}
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"exact_snippets": "Healthy volunteers allowed",
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}
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}
},
{
"identified_line": {
"line": "Must be FEMALE",
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{
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}
},
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"unit": "Years"
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"line": "* contraindications for laparoscopic surgery;",
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"requirement": {
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}
}
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"expected_value": false
}
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},
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"criterion": "acute intestinal obstruction",
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"expected_value": true
}
},
{
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"expected_value": true
}
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{
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"expected_value": true
}
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}
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}
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"expected_value": true
}
}
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}
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{
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"expected_value": true
}
}
]
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}
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"line": "* multiple colorectal cancer;",
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{
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"criterion": "colorectal cancer",
"requirement": {
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"expected_value": "multiple"
}
}
]
},
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"requirement": {
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}
}
}
},
{
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"line": "* has received preoperative chemoradiotherapy;",
"criterions": [
{
"exact_snippets": "has received preoperative chemoradiotherapy",
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}
}
]
},
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}
}
},
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"line": "* with a history of other malignant tumors;",
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{
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"criterion": "other malignant tumors",
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}
}
]
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}
}
}
},
{
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}
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],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}