{
    "info": {
        "nct_id": "NCT06802991",
        "official_title": "Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)",
        "inclusion_criteria": "* Age 65+\n* Clinical Frailty Scale preoperative score 4-7\n* Nutritional Risk Screening tool (NRS 2002) > 3\n* Elective colonic resection\n* No stoma planned\n* Minimally invasive surgical approach (laparoscopic or robotic)\n* Patients discharged to own home\n* Informed consent to participate\nHealthy volunteers allowed\nMust have minimum age of 65 Years",
        "exclusion_criteria": "* Stoma creation during index surgery\n* Conversion to laparotomy\n* Major complications following surgery (Clavien-Dindo >3a)\n* Participation in other randomised trials in conflict with the protocol and end- points of the ERAS 3.0 project\n* Discharged with tube feeding and parenteral nutrition (partially or completely)\n* Known food allergies to dairy or any other ingredient contained in the nutrition package\n* Incapable of providing informed consent\n* Discharge to 24-hour municipal rehabilitation facility\n* All conditions including psychological, geographical, and social factors that could hinder adherence to the trial protocol\n* Neoadjuvant radio- or chemotherapy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age 65+",
            "criterions": [
                {
                    "exact_snippets": "Age 65+",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical Frailty Scale preoperative score 4-7",
            "criterions": [
                {
                    "exact_snippets": "Clinical Frailty Scale preoperative score 4-7",
                    "criterion": "Clinical Frailty Scale preoperative score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 7,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Nutritional Risk Screening tool (NRS 2002) > 3",
            "criterions": [
                {
                    "exact_snippets": "Nutritional Risk Screening tool (NRS 2002) > 3",
                    "criterion": "Nutritional Risk Screening tool (NRS 2002)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Elective colonic resection",
            "criterions": [
                {
                    "exact_snippets": "Elective colonic resection",
                    "criterion": "colonic resection",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "elective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No stoma planned",
            "criterions": [
                {
                    "exact_snippets": "No stoma planned",
                    "criterion": "stoma",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Minimally invasive surgical approach (laparoscopic or robotic)",
            "criterions": [
                {
                    "exact_snippets": "Minimally invasive surgical approach (laparoscopic or robotic)",
                    "criterion": "surgical approach",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "laparoscopic",
                                "robotic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients discharged to own home",
            "criterions": [
                {
                    "exact_snippets": "discharged to own home",
                    "criterion": "discharge location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "own home"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed consent to participate",
            "criterions": [
                {
                    "exact_snippets": "Informed consent to participate",
                    "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 65 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Stoma creation during index surgery",
            "criterions": [
                {
                    "exact_snippets": "Stoma creation during index surgery",
                    "criterion": "stoma creation",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during index surgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Conversion to laparotomy",
            "criterions": [
                {
                    "exact_snippets": "Conversion to laparotomy",
                    "criterion": "conversion to laparotomy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major complications following surgery (Clavien-Dindo >3a)",
            "criterions": [
                {
                    "exact_snippets": "Major complications following surgery (Clavien-Dindo >3a)",
                    "criterion": "major complications following surgery",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "Clavien-Dindo"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation in other randomised trials in conflict with the protocol and end- points of the ERAS 3.0 project",
            "criterions": [
                {
                    "exact_snippets": "Participation in other randomised trials in conflict with the protocol and end- points of the ERAS 3.0 project",
                    "criterion": "participation in other randomised trials",
                    "requirements": [
                        {
                            "requirement_type": "conflict with protocol and end-points of the ERAS 3.0 project",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Discharged with tube feeding and parenteral nutrition (partially or completely)",
            "criterions": [
                {
                    "exact_snippets": "Discharged with tube feeding",
                    "criterion": "tube feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Discharged with ... parenteral nutrition (partially or completely)",
                    "criterion": "parenteral nutrition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "completeness",
                            "expected_value": [
                                "partially",
                                "completely"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known food allergies to dairy or any other ingredient contained in the nutrition package",
            "criterions": [
                {
                    "exact_snippets": "Known food allergies to dairy",
                    "criterion": "food allergies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": "dairy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Known food allergies to ... any other ingredient contained in the nutrition package",
                    "criterion": "food allergies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": "any other ingredient contained in the nutrition package"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Incapable of providing informed consent",
            "criterions": [
                {
                    "exact_snippets": "Incapable of providing informed consent",
                    "criterion": "informed consent capability",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Discharge to 24-hour municipal rehabilitation facility",
            "criterions": [
                {
                    "exact_snippets": "Discharge to 24-hour municipal rehabilitation facility",
                    "criterion": "discharge destination",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "24-hour municipal rehabilitation facility"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All conditions including psychological, geographical, and social factors that could hinder adherence to the trial protocol",
            "criterions": [
                {
                    "exact_snippets": "psychological ... hinder adherence to the trial protocol",
                    "criterion": "psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on adherence",
                            "expected_value": "hinder"
                        }
                    ]
                },
                {
                    "exact_snippets": "geographical ... hinder adherence to the trial protocol",
                    "criterion": "geographical factors",
                    "requirements": [
                        {
                            "requirement_type": "impact on adherence",
                            "expected_value": "hinder"
                        }
                    ]
                },
                {
                    "exact_snippets": "social factors ... hinder adherence to the trial protocol",
                    "criterion": "social factors",
                    "requirements": [
                        {
                            "requirement_type": "impact on adherence",
                            "expected_value": "hinder"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neoadjuvant radio- or chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Neoadjuvant radio- or chemotherapy",
                    "criterion": "neoadjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "radiotherapy",
                                "chemotherapy"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}