{
    "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": ""
    },
    "inclusion_lines": [
        {
            "line": "* volunteer to participate and the informed consent signed;",
            "criterions": [
                {
                    "exact_snippets": "volunteer to participate",
                    "criterion": "volunteer status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "volunteer"
                        }
                    ]
                },
                {
                    "exact_snippets": "informed consent signed",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "signed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18-75 years;",
            "criterions": [
                {
                    "exact_snippets": "18-75 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* female who have given birth;",
            "criterions": [
                {
                    "exact_snippets": "female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "have given birth",
                    "criterion": "parity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "given birth"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* pathologically confirmed adenocarcinoma/high-grade intraepithelial neoplasia by preoperative colonoscopy and biopsy;",
            "criterions": [
                {
                    "exact_snippets": "pathologically confirmed adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "pathologically confirmed ... high-grade intraepithelial neoplasia",
                    "criterion": "high-grade intraepithelial neoplasia",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "preoperative colonoscopy and biopsy",
                    "criterion": "colonoscopy and biopsy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "preoperative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* preoperative CT or MRI indicates that the tumor diameter is no more than 5.0 cm;",
            "criterions": [
                {
                    "exact_snippets": "preoperative CT or MRI indicates that the tumor diameter is no more than 5.0 cm",
                    "criterion": "tumor diameter",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5.0,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* preoperative staging cT1-3NanyM0",
            "criterions": [
                {
                    "exact_snippets": "preoperative staging cT1-3",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "preoperative staging ... Nany",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "preoperative staging ... M0",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "M"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* body mass index <30 kg/m2;",
            "criterions": [
                {
                    "exact_snippets": "body mass index <30 kg/m2",
                    "criterion": "body mass index",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "kg/m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* willing to undergo laparoscopic right hemicolectomy",
            "criterions": [
                {
                    "exact_snippets": "willing to undergo laparoscopic right hemicolectomy",
                    "criterion": "willingness to undergo laparoscopic right hemicolectomy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* contraindications for laparoscopic surgery;",
            "criterions": [
                {
                    "exact_snippets": "contraindications for laparoscopic surgery",
                    "criterion": "contraindications for laparoscopic surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* emergency surgery due to acute intestinal obstruction, perforation or bleeding;",
            "criterions": [
                {
                    "exact_snippets": "emergency surgery due to acute intestinal obstruction",
                    "criterion": "acute intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "necessity for emergency surgery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "emergency surgery due to ... perforation",
                    "criterion": "perforation",
                    "requirements": [
                        {
                            "requirement_type": "necessity for emergency surgery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "emergency surgery due to ... bleeding",
                    "criterion": "bleeding",
                    "requirements": [
                        {
                            "requirement_type": "necessity for emergency surgery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* distant metastasis;",
            "criterions": [
                {
                    "exact_snippets": "distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* multiple colorectal cancer;",
            "criterions": [
                {
                    "exact_snippets": "multiple colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "multiple"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* has received preoperative chemoradiotherapy;",
            "criterions": [
                {
                    "exact_snippets": "has received preoperative chemoradiotherapy",
                    "criterion": "preoperative chemoradiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* with a history of other malignant tumors;",
            "criterions": [
                {
                    "exact_snippets": "history of other malignant tumors",
                    "criterion": "other malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* unwilling to sign the informed consent or receive follow-up according to the study protocol.",
            "criterions": [
                {
                    "exact_snippets": "unwilling to sign the informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling to ... receive follow-up according to the study protocol",
                    "criterion": "follow-up according to the study protocol",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}