{
"info": {
"nct_id": "NCT04252560",
"official_title": "The Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer.",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Ongoing antibiotics treatment\n* antibiotics treatment in the last 6 months\n* acute surgery\n* palliative surgery\n* Ulcerös colitis or Crohns disease\n* Prior colectomy\n* Small intestine stoma before the operation\n* neoadjuvant treatment\n* Colon preparation",
"miscellaneous_criteria": "Inclusion Criteria Colorectal group\n\n* adenocarcinom in colon or rektum\n* curative operation planed\n* direct anastomose plan\n* elective surgery\n\nInclusion Criteria HIPEC group :\n\n* All patients with appendix, colon or rectal cancer accepted for CRS+HIPEC"
},
"inclusion_lines": [
{
"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": "* Ongoing antibiotics treatment",
"criterions": [
{
"exact_snippets": "Ongoing antibiotics treatment",
"criterion": "antibiotics treatment",
"requirements": [
{
"requirement_type": "status",
"expected_value": "ongoing"
}
]
}
]
},
{
"line": "* antibiotics treatment in the last 6 months",
"criterions": [
{
"exact_snippets": "antibiotics treatment in the last 6 months",
"criterion": "antibiotics treatment",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
}
]
},
{
"line": "* acute surgery",
"criterions": [
{
"exact_snippets": "acute surgery",
"criterion": "acute surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* palliative surgery",
"criterions": [
{
"exact_snippets": "palliative surgery",
"criterion": "palliative surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Ulcerös colitis or Crohns disease",
"criterions": [
{
"exact_snippets": "Ulcerös colitis",
"criterion": "Ulcerös colitis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Crohns disease",
"criterion": "Crohns disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Prior colectomy",
"criterions": [
{
"exact_snippets": "Prior colectomy",
"criterion": "colectomy",
"requirements": [
{
"requirement_type": "prior occurrence",
"expected_value": true
}
]
}
]
},
{
"line": "* Small intestine stoma before the operation",
"criterions": [
{
"exact_snippets": "Small intestine stoma before the operation",
"criterion": "small intestine stoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* neoadjuvant treatment",
"criterions": [
{
"exact_snippets": "neoadjuvant treatment",
"criterion": "neoadjuvant treatment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Colon preparation",
"criterions": [
{
"exact_snippets": "Colon preparation",
"criterion": "colon preparation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [
{
"line": "Inclusion Criteria Colorectal group",
"criterions": [
{
"exact_snippets": "Colorectal group",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "specificity",
"expected_value": "colorectal"
}
]
}
]
},
{
"line": "* adenocarcinom in colon or rektum",
"criterions": [
{
"exact_snippets": "adenocarcinom in colon",
"criterion": "adenocarcinoma in colon",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "adenocarcinom in ... rektum",
"criterion": "adenocarcinoma in rectum",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* curative operation planed",
"criterions": [
{
"exact_snippets": "curative operation planed",
"criterion": "operation plan",
"requirements": [
{
"requirement_type": "type",
"expected_value": "curative"
}
]
}
]
},
{
"line": "* direct anastomose plan",
"criterions": [
{
"exact_snippets": "direct anastomose plan",
"criterion": "anastomosis plan",
"requirements": [
{
"requirement_type": "type",
"expected_value": "direct"
}
]
}
]
},
{
"line": "* elective surgery",
"criterions": [
{
"exact_snippets": "elective surgery",
"criterion": "elective surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* All patients with appendix, colon or rectal cancer accepted for CRS+HIPEC",
"criterions": [
{
"exact_snippets": "appendix, colon or rectal cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"appendix",
"colon",
"rectal"
]
}
]
},
{
"exact_snippets": "accepted for CRS+HIPEC",
"criterion": "CRS+HIPEC acceptance",
"requirements": [
{
"requirement_type": "acceptance",
"expected_value": true
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "Inclusion Criteria HIPEC group :",
"criterions": []
}
]
}