{
    "info": {
        "nct_id": "NCT02943694",
        "official_title": "The Feasibility and Safety of Instruments in Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer",
        "inclusion_criteria": "* rectal cancer patients, confirmed by the endoscopic biopsy;\n* curative rectal cancer in clinical stage with resectable lesion, the cTNM stage <T3 stage, with comparable tumor size in low or medial rectum.\n* patients' general information, 18ys<age<75ys, no restriction in genders, BMI< or =30kg/m2, no presentation of severe chronic diseases (i.e. COPD), WHO classification <2 (Zubrod-ECOG-WHO)\n* patients or representatives have agreed and signed the informed consent documents.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* have received neo-adjuvant chemotherapy or radiotherapy before operations;\n* previous surgery in pelvis\n* uncontrollable diseases such as diseases in cardiopulmonary function, chronic bronchitis, severe hepatitis/diabetes/malnutrition/renal function.\n* suffer from other malignant diseases, i.e. gastric cancer, liver cancer.\n* pregnant, lactation stage.\n* metal disorders.\n* lacking qualified compliance.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* rectal cancer patients, confirmed by the endoscopic biopsy;",
            "criterions": [
                {
                    "exact_snippets": "rectal cancer patients",
                    "criterion": "rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by the endoscopic biopsy",
                    "criterion": "endoscopic biopsy confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* curative rectal cancer in clinical stage with resectable lesion, the cTNM stage <T3 stage, with comparable tumor size in low or medial rectum.",
            "criterions": [
                {
                    "exact_snippets": "curative rectal cancer",
                    "criterion": "rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "curative",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical stage",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "resectable lesion",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cTNM stage <T3 stage",
                    "criterion": "cTNM stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "T"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "comparable tumor size in low or medial rectum",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "low rectum",
                                "medial rectum"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patients' general information, 18ys<age<75ys, no restriction in genders, BMI< or =30kg/m2, no presentation of severe chronic diseases (i.e. COPD), WHO classification <2 (Zubrod-ECOG-WHO)",
            "criterions": [
                {
                    "exact_snippets": "18ys<age<75ys",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "ys"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 75,
                                        "unit": "ys"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no restriction in genders",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "restriction",
                            "expected_value": "none"
                        }
                    ]
                },
                {
                    "exact_snippets": "BMI< or =30kg/m2",
                    "criterion": "BMI",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "kg/m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no presentation of severe chronic diseases (i.e. COPD)",
                    "criterion": "severe chronic diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "WHO classification <2 (Zubrod-ECOG-WHO)",
                    "criterion": "WHO classification",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patients or representatives have agreed and signed the informed consent documents.",
            "criterions": [
                {
                    "exact_snippets": "patients or representatives have agreed and signed the informed consent documents",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "signature",
                            "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 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": "* have received neo-adjuvant chemotherapy or radiotherapy before operations;",
            "criterions": [
                {
                    "exact_snippets": "have received neo-adjuvant chemotherapy",
                    "criterion": "neo-adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have received ... radiotherapy before operations",
                    "criterion": "radiotherapy before operations",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* previous surgery in pelvis",
            "criterions": [
                {
                    "exact_snippets": "previous surgery in pelvis",
                    "criterion": "previous surgery in pelvis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* uncontrollable diseases such as diseases in cardiopulmonary function, chronic bronchitis, severe hepatitis/diabetes/malnutrition/renal function.",
            "criterions": [
                {
                    "exact_snippets": "uncontrollable diseases such as diseases in cardiopulmonary function",
                    "criterion": "cardiopulmonary function",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable diseases such as ... chronic bronchitis",
                    "criterion": "chronic bronchitis",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable diseases such as ... severe hepatitis",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable diseases such as ... severe ... diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable diseases such as ... severe ... malnutrition",
                    "criterion": "malnutrition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable diseases such as ... severe ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* suffer from other malignant diseases, i.e. gastric cancer, liver cancer.",
            "criterions": [
                {
                    "exact_snippets": "suffer from other malignant diseases, i.e. gastric cancer",
                    "criterion": "gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "suffer from other malignant diseases, i.e. ... liver cancer",
                    "criterion": "liver cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* pregnant, lactation stage.",
            "criterions": [
                {
                    "exact_snippets": "pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation stage",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* metal disorders.",
            "criterions": [
                {
                    "exact_snippets": "metal disorders",
                    "criterion": "metal disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* lacking qualified compliance.",
            "criterions": [
                {
                    "exact_snippets": "lacking qualified compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "qualification",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}