{
    "info": {
        "nct_id": "NCT04230772",
        "official_title": "A Randomized Controlled Trial Comparing Clinical Outcomes of Natural Orifice Specimen Extraction Surgery Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer",
        "inclusion_criteria": "1. Age ≥ 18 and ≤ 80 years;\n2. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;\n3. Histological or cytological confirmation of colorectal adenocarcinoma;\n4. High rectal and sigmoid cancer with the lower margin of the tumor greater than 10 cm from the anal dentate line;\n5. T1-3N0M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition, Transvaginal NOSES procedure w specimen with a circumferential diameter of <5 cm;\n6. Preoperative examination did not suggest distant metastasis, implantation or invasion of adjacent organs;\n7. Cardiopulmonary liver and kidney function can withstand surgery;\n8. Written informed consent for participation in the trial.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "1. Not suitable for robot laparoscopic surgery;\n2. The tumor is too large to be pulled out through the anus or vagina;\n3. Simultaneous multiple primary cancer;\n4. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by primary cancer\n5. Women with acute gynecological infections, vaginal deformities, unmarried and infertile women and women who are married and plan to get pregnant.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age ≥ 18 and ≤ 80 years;",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 and ≤ 80 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;",
            "criterions": [
                {
                    "exact_snippets": "Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histological or cytological confirmation of colorectal adenocarcinoma;",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological confirmation of colorectal adenocarcinoma",
                    "criterion": "colorectal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. High rectal and sigmoid cancer with the lower margin of the tumor greater than 10 cm from the anal dentate line;",
            "criterions": [
                {
                    "exact_snippets": "High rectal and sigmoid cancer",
                    "criterion": "cancer location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "high rectal",
                                "sigmoid"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "lower margin of the tumor greater than 10 cm from the anal dentate line",
                    "criterion": "tumor margin distance",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. T1-3N0M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition, Transvaginal NOSES procedure w specimen with a circumferential diameter of <5 cm;",
            "criterions": [
                {
                    "exact_snippets": "T1-3N0M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T1-3N0M0"
                        }
                    ]
                },
                {
                    "exact_snippets": "Transvaginal NOSES procedure",
                    "criterion": "surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "Transvaginal NOSES"
                        }
                    ]
                },
                {
                    "exact_snippets": "specimen with a circumferential diameter of <5 cm",
                    "criterion": "specimen size",
                    "requirements": [
                        {
                            "requirement_type": "diameter",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Preoperative examination did not suggest distant metastasis, implantation or invasion of adjacent organs;",
            "criterions": [
                {
                    "exact_snippets": "Preoperative examination did not suggest distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Preoperative examination did not suggest ... implantation",
                    "criterion": "implantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Preoperative examination did not suggest ... invasion of adjacent organs",
                    "criterion": "invasion of adjacent organs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Cardiopulmonary liver and kidney function can withstand surgery;",
            "criterions": [
                {
                    "exact_snippets": "Cardiopulmonary liver and kidney function can withstand surgery",
                    "criterion": "cardiopulmonary function",
                    "requirements": [
                        {
                            "requirement_type": "surgical tolerance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiopulmonary liver and kidney function can withstand surgery",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "surgical tolerance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiopulmonary liver and kidney function can withstand surgery",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "surgical tolerance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Written informed consent for participation in the trial.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent for participation in the trial.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "1. Not suitable for robot laparoscopic surgery;",
            "criterions": [
                {
                    "exact_snippets": "Not suitable for robot laparoscopic surgery",
                    "criterion": "suitability for robot laparoscopic surgery",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. The tumor is too large to be pulled out through the anus or vagina;",
            "criterions": [
                {
                    "exact_snippets": "The tumor is too large to be pulled out through the anus or vagina",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": "too large to be pulled out through the anus or vagina"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Simultaneous multiple primary cancer;",
            "criterions": [
                {
                    "exact_snippets": "Simultaneous multiple primary cancer",
                    "criterion": "multiple primary cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by primary cancer",
            "criterions": [
                {
                    "exact_snippets": "Emergency surgery due to complication (bleeding, obstruction or perforation) caused by primary cancer",
                    "criterion": "emergency surgery",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "complication caused by primary cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "complication (bleeding, obstruction or perforation)",
                    "criterion": "complication",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "bleeding",
                                "obstruction",
                                "perforation"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Women with acute gynecological infections, vaginal deformities, unmarried and infertile women and women who are married and plan to get pregnant.",
            "criterions": [
                {
                    "exact_snippets": "acute gynecological infections",
                    "criterion": "acute gynecological infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "vaginal deformities",
                    "criterion": "vaginal deformities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unmarried",
                    "criterion": "marital status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "unmarried"
                        }
                    ]
                },
                {
                    "exact_snippets": "infertile women",
                    "criterion": "fertility status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "infertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "married and plan to get pregnant",
                    "criterion": "marital status and pregnancy plans",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "married"
                        },
                        {
                            "requirement_type": "pregnancy plans",
                            "expected_value": "plan to get pregnant"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}