{
    "info": {
        "nct_id": "NCT05074082",
        "official_title": "PelvEx 8: Perineal Flap Reconstruction Following Surgery for Advanced Pelvic Malignancy",
        "inclusion_criteria": "* Histologically proven locally advanced or recurrent pelvic cancer (all subtypes - Rectal, Urological, Gynaecological, Sarcoma)\n* Aged over 18 years\n* Undergoing a multi-visceral extended pelvic resection and requiring reconstruction of a skin and soft tissue defect as a result\n* Time period: 1st July 2016 - 1st July 2021\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Strong evidence of metastatic or peritoneal disease\n* No immediate flap reconstruction performed at time of extended pelvic resection/pelvic exenteration, or flap reconstruction performed as a delayed procedure or as a response to a complication of prior pelvic exenteration\n* Insufficient patient follow-up (Minimum of 30 days)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically proven locally advanced or recurrent pelvic cancer (all subtypes - Rectal, Urological, Gynaecological, Sarcoma)",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven",
                    "criterion": "histological proof",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or recurrent pelvic cancer",
                    "criterion": "pelvic cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "all subtypes - Rectal, Urological, Gynaecological, Sarcoma",
                    "criterion": "cancer subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "Rectal",
                                "Urological",
                                "Gynaecological",
                                "Sarcoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aged over 18 years",
            "criterions": [
                {
                    "exact_snippets": "Aged over 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Undergoing a multi-visceral extended pelvic resection and requiring reconstruction of a skin and soft tissue defect as a result",
            "criterions": [
                {
                    "exact_snippets": "Undergoing a multi-visceral extended pelvic resection",
                    "criterion": "multi-visceral extended pelvic resection",
                    "requirements": [
                        {
                            "requirement_type": "undergoing",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring reconstruction of a skin and soft tissue defect",
                    "criterion": "reconstruction of a skin and soft tissue defect",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Time period: 1st July 2016 - 1st July 2021",
            "criterions": [
                {
                    "exact_snippets": "Time period: 1st July 2016 - 1st July 2021",
                    "criterion": "time period",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2016,
                                        "unit": "year"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2021,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Strong evidence of metastatic or peritoneal disease",
            "criterions": [
                {
                    "exact_snippets": "Strong evidence of metastatic ... disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "strong"
                        }
                    ]
                },
                {
                    "exact_snippets": "Strong evidence of ... peritoneal disease",
                    "criterion": "peritoneal disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "strong"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No immediate flap reconstruction performed at time of extended pelvic resection/pelvic exenteration, or flap reconstruction performed as a delayed procedure or as a response to a complication of prior pelvic exenteration",
            "criterions": [
                {
                    "exact_snippets": "No immediate flap reconstruction performed at time of extended pelvic resection/pelvic exenteration",
                    "criterion": "immediate flap reconstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "flap reconstruction performed as a delayed procedure",
                    "criterion": "delayed flap reconstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "flap reconstruction performed ... as a response to a complication of prior pelvic exenteration",
                    "criterion": "flap reconstruction due to complication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Insufficient patient follow-up (Minimum of 30 days)",
            "criterions": [
                {
                    "exact_snippets": "Insufficient patient follow-up (Minimum of 30 days)",
                    "criterion": "patient follow-up duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}