{
"info": {
"nct_id": "NCT04733794",
"official_title": "Feasibility of Implementing a Comprehensive, Patient-Centered Approach to Bowel Dysfunction After Low Anterior Resection for Rectal Cancer",
"inclusion_criteria": "* Diagnosis of Stage II or III rectal cancer, a history of having an LAR with diverting stoma, and a plan to undergo stoma reversal within the next 6 months\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Patients enrolled who develop an anastomotic leak at the time of stoma reversal that would necessitate another temporary or permanent stoma, they will be considered unevaluable and will be excluded from the analysis",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Diagnosis of Stage II or III rectal cancer, a history of having an LAR with diverting stoma, and a plan to undergo stoma reversal within the next 6 months",
"criterions": [
{
"exact_snippets": "Diagnosis of Stage II or III rectal cancer",
"criterion": "rectal cancer",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"Stage II",
"Stage III"
]
}
]
},
{
"exact_snippets": "a history of having an LAR with diverting stoma",
"criterion": "LAR with diverting stoma",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "a plan to undergo stoma reversal within the next 6 months",
"criterion": "stoma reversal",
"requirements": [
{
"requirement_type": "plan",
"expected_value": true
},
{
"requirement_type": "timeframe",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"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": "* Patients enrolled who develop an anastomotic leak at the time of stoma reversal that would necessitate another temporary or permanent stoma, they will be considered unevaluable and will be excluded from the analysis",
"criterions": [
{
"exact_snippets": "develop an anastomotic leak at the time of stoma reversal",
"criterion": "anastomotic leak at the time of stoma reversal",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "necessitate another temporary or permanent stoma",
"criterion": "necessity of another stoma",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}