{
    "info": {
        "nct_id": "NCT05879172",
        "official_title": "Application of Electric Tubular Anastomotic Device in Colorectal Tumor Surgery: a Multi-center Clinical Trial",
        "inclusion_criteria": "* Age: 18-80y;\n* Patients with resectable rectal cancer who are scheduled to undergo Dixon surgery (definition of rectal cancer: the lower boundary of the tumor is 10 cm from the anus≤);\n* The patient consents to participate in the clinical study and signs the informed consent form.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Patients with significant local or systemic severe infection;\n* Acute abdomen: intestinal obstruction, peritonitis, intestinal perforation;\n* Have a systemic underlying disease that has not been controlled, or is unstable; Patients with poor constitution or serious other organic diseases who cannot tolerate anesthesia and surgery;\n* Women during pregnancy, perinatal and lactation;\n* Patients who are mentally incapable or unable to understand the requirements of the study;\n* Patients who participated in other clinical studies 6 weeks before the start of this study or at the same time;\n* The life expectancy of patients with malignant tumors is less than 6 months;\n* Those who are critically ill and find it difficult to make an accurate evaluation of the effectiveness and safety of the device;\n* Patients with diseases who are believed not suitable to participate in this clinical study;\n* Have other diseases that are against anastomosis;\n* The patient is receiving hormone therapy or immunosuppressive therapy;\n* Albumin< 30g/dl.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age: 18-80y;",
            "criterions": [
                {
                    "exact_snippets": "Age: 18-80y",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "y"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "y"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with resectable rectal cancer who are scheduled to undergo Dixon surgery (definition of rectal cancer: the lower boundary of the tumor is 10 cm from the anus≤);",
            "criterions": [
                {
                    "exact_snippets": "resectable rectal cancer",
                    "criterion": "rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled to undergo Dixon surgery",
                    "criterion": "Dixon surgery",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the lower boundary of the tumor is 10 cm from the anus≤",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "cm from the anus"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient consents to participate in the clinical study and signs the informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "The patient consents to participate in the clinical study",
                    "criterion": "consent to participate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signs the informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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 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": "* Patients with significant local or systemic severe infection;",
            "criterions": [
                {
                    "exact_snippets": "significant local or systemic severe infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "local",
                                "systemic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a systemic underlying disease that has not been controlled, or is unstable; Patients with poor constitution or serious other organic diseases who cannot tolerate anesthesia and surgery;",
            "criterions": [
                {
                    "exact_snippets": "systemic underlying disease that has not been controlled, or is unstable",
                    "criterion": "systemic underlying disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "poor constitution",
                    "criterion": "constitution",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious other organic diseases",
                    "criterion": "other organic diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot tolerate anesthesia and surgery",
                    "criterion": "tolerance to anesthesia and surgery",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women during pregnancy, perinatal and lactation;",
            "criterions": [
                {
                    "exact_snippets": "Women during pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "perinatal",
                    "criterion": "perinatal period",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are mentally incapable or unable to understand the requirements of the study;",
            "criterions": [
                {
                    "exact_snippets": "mentally incapable",
                    "criterion": "mental capability",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to understand the requirements of the study",
                    "criterion": "understanding of study requirements",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who participated in other clinical studies 6 weeks before the start of this study or at the same time;",
            "criterions": [
                {
                    "exact_snippets": "Patients who participated in other clinical studies 6 weeks before the start of this study",
                    "criterion": "participation in other clinical studies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who participated in other clinical studies ... at the same time",
                    "criterion": "participation in other clinical studies",
                    "requirements": [
                        {
                            "requirement_type": "concurrent participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The life expectancy of patients with malignant tumors is less than 6 months;",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of patients with malignant tumors is less than 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Those who are critically ill and find it difficult to make an accurate evaluation of the effectiveness and safety of the device;",
            "criterions": [
                {
                    "exact_snippets": "critically ill",
                    "criterion": "critical illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "find it difficult to make an accurate evaluation of the effectiveness and safety of the device",
                    "criterion": "ability to evaluate device effectiveness and safety",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with diseases who are believed not suitable to participate in this clinical study;",
            "criterions": [
                {
                    "exact_snippets": "diseases",
                    "criterion": "diseases",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have other diseases that are against anastomosis;",
            "criterions": [
                {
                    "exact_snippets": "other diseases that are against anastomosis",
                    "criterion": "diseases against anastomosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient is receiving hormone therapy or immunosuppressive therapy;",
            "criterions": [
                {
                    "exact_snippets": "The patient is receiving hormone therapy",
                    "criterion": "hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The patient is receiving ... immunosuppressive therapy",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin< 30g/dl.",
            "criterions": [
                {
                    "exact_snippets": "Albumin< 30g/dl",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Acute abdomen: intestinal obstruction, peritonitis, intestinal perforation;",
            "criterions": [
                {
                    "exact_snippets": "Acute abdomen: intestinal obstruction",
                    "criterion": "acute abdomen",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "intestinal obstruction"
                        }
                    ]
                },
                {
                    "exact_snippets": "Acute abdomen: peritonitis",
                    "criterion": "acute abdomen",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "peritonitis"
                        }
                    ]
                },
                {
                    "exact_snippets": "Acute abdomen: intestinal perforation",
                    "criterion": "acute abdomen",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "intestinal perforation"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}