{
    "info": {
        "nct_id": "NCT06591572",
        "official_title": "Efficacy and Safety Assessment of Single-port Robotic Versus Laparoscopic Transanal Total Mesorectal Excision for Mid and Low Rectal Cancer: a Phase 2a Nonrandomized Controlled Trial Based on the IDEAL Framework",
        "inclusion_criteria": "* (1) Mid or low rectal cancer, 0-10 cm from the anal verge (MRI definition); (2) Histological biopsy showing adenocarcinoma; (3) Stage I-III (MRI and abdominal CT), including the downstaged after neoadjuvant therapy; (4) Intention for primary anastomosis; (5) Obtain the informed consent of the patient and his family; (6) Suitable for robotic or laparoscopic surgery. (7) Over 18 years old.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. T3 tumour with margins less than 1 mm to the mesorectal fascia or T4 tumour, determined by MRI-scan (staged after (chemo)radiotherapy if applicable) ;\n2. The anal sphincter complex or levator anal muscle is involved;\n3. Previous prostate or rectal surgery (excluding local excision) ;\n4. Emergency surgery was performed due to complications of a rectal tumor;\n5. Malignancy other than adenocarcinoma at histological examination;\n6. Pregnancy;\n7. Signs of acute intestinal obstruction;\n8. Multiple colorectal tumours;\n9. Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative colitis;\n10. Planned synchronous abdominal organ resections;\n11. Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;\n12. Absolute contraindication to general anaesthesia or prolonged pneumoperitoneum, as severe cardiovascular or respiratory disease (ASA class > III)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* (1) Mid or low rectal cancer, 0-10 cm from the anal verge (MRI definition); (2) Histological biopsy showing adenocarcinoma; (3) Stage I-III (MRI and abdominal CT), including the downstaged after neoadjuvant therapy; (4) Intention for primary anastomosis; (5) Obtain the informed consent of the patient and his family; (6) Suitable for robotic or laparoscopic surgery. (7) Over 18 years old.",
            "criterions": [
                {
                    "exact_snippets": "Mid or low rectal cancer, 0-10 cm from the anal verge (MRI definition)",
                    "criterion": "rectal cancer location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "mid or low rectal"
                        },
                        {
                            "requirement_type": "distance from anal verge",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "cm"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "cm"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Histological biopsy showing adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage I-III (MRI and abdominal CT), including the downstaged after neoadjuvant therapy",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II",
                                "III"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Intention for primary anastomosis",
                    "criterion": "intention for primary anastomosis",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Obtain the informed consent of the patient and his family",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "obtained",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Suitable for robotic or laparoscopic surgery",
                    "criterion": "suitability for surgery",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": [
                                "robotic",
                                "laparoscopic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Over 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. T3 tumour with margins less than 1 mm to the mesorectal fascia or T4 tumour, determined by MRI-scan (staged after (chemo)radiotherapy if applicable) ;",
            "criterions": [
                {
                    "exact_snippets": "T3 tumour",
                    "criterion": "tumour stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T3"
                        }
                    ]
                },
                {
                    "exact_snippets": "margins less than 1 mm to the mesorectal fascia",
                    "criterion": "tumour margin to mesorectal fascia",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "T4 tumour",
                    "criterion": "tumour stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T4"
                        }
                    ]
                },
                {
                    "exact_snippets": "determined by MRI-scan",
                    "criterion": "tumour determination method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "MRI-scan"
                        }
                    ]
                },
                {
                    "exact_snippets": "staged after (chemo)radiotherapy if applicable",
                    "criterion": "staging timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "after (chemo)radiotherapy if applicable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. The anal sphincter complex or levator anal muscle is involved;",
            "criterions": [
                {
                    "exact_snippets": "The anal sphincter complex or levator anal muscle is involved",
                    "criterion": "anal sphincter complex involvement",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The anal sphincter complex or levator anal muscle is involved",
                    "criterion": "levator anal muscle involvement",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Previous prostate or rectal surgery (excluding local excision) ;",
            "criterions": [
                {
                    "exact_snippets": "Previous prostate or rectal surgery (excluding local excision)",
                    "criterion": "prostate or rectal surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "local excision"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Emergency surgery was performed due to complications of a rectal tumor;",
            "criterions": [
                {
                    "exact_snippets": "Emergency surgery was performed due to complications of a rectal tumor",
                    "criterion": "emergency surgery",
                    "requirements": [
                        {
                            "requirement_type": "reason",
                            "expected_value": "complications of a rectal tumor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Malignancy other than adenocarcinoma at histological examination;",
            "criterions": [
                {
                    "exact_snippets": "Malignancy other than adenocarcinoma at histological examination",
                    "criterion": "malignancy type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "adenocarcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Pregnancy;",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Signs of acute intestinal obstruction;",
            "criterions": [
                {
                    "exact_snippets": "Signs of acute intestinal obstruction",
                    "criterion": "acute intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Multiple colorectal tumours;",
            "criterions": [
                {
                    "exact_snippets": "Multiple colorectal tumours",
                    "criterion": "colorectal tumours",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": ">1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative colitis;",
            "criterions": [
                {
                    "exact_snippets": "Familial Adenomatosis Polyposis Coli (FAP)",
                    "criterion": "Familial Adenomatosis Polyposis Coli (FAP)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hereditary Non-Polyposis Colorectal Cancer (HNPCC)",
                    "criterion": "Hereditary Non-Polyposis Colorectal Cancer (HNPCC)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active Crohn's disease",
                    "criterion": "active Crohn's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active ulcerative colitis",
                    "criterion": "active ulcerative colitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Planned synchronous abdominal organ resections;",
            "criterions": [
                {
                    "exact_snippets": "Planned synchronous abdominal organ resections",
                    "criterion": "synchronous abdominal organ resections",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;",
            "criterions": [
                {
                    "exact_snippets": "Other malignancies in medical history",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated basocellular carcinoma of the skin",
                    "criterion": "basocellular carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ carcinoma of the cervix uteri",
                    "criterion": "in situ carcinoma of the cervix uteri",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Absolute contraindication to general anaesthesia or prolonged pneumoperitoneum, as severe cardiovascular or respiratory disease (ASA class > III)",
            "criterions": [
                {
                    "exact_snippets": "Absolute contraindication to general anaesthesia",
                    "criterion": "general anaesthesia",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute contraindication to ... prolonged pneumoperitoneum",
                    "criterion": "prolonged pneumoperitoneum",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe cardiovascular or respiratory disease",
                    "criterion": "cardiovascular or respiratory disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "ASA class > III",
                    "criterion": "ASA class",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}