| Protocol ID | NCT02473744 |
| Registration Date | 2015-06-17 |
| Status | Terminated |
| Sponsor | University Hospital, Limoges |
| Country | France |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2015-07-27 |
| Last Patient Out | 2017-07-20 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT02473744
Oedematous Lower Limb Subcutaneous Drainage in Palliative Care
| Field |
GLM
glm-5.1 10604ms / 9123 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 6501ms / 10439 tok |
OPENAI
gpt-4o Thinking: o3 4168ms / 8963 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status |
non-cancer
non-cancer → non-cancer
shaky reasoning✓ Unanimous
Initial: non-cancer
Requery: non-cancer — The trial's eligibility criteria explicitly include palliative care patients with edema from any etiology, specifically noting 'whatever etiology involved (cancer, organ failure, hypoalbuminemia…)', indicating it is a mixed population rather than exclusively cancer.
|
non-cancer
non-cancer → Cancer → non-cancer
shaky reasoning✓ Unanimous
Initial: non-cancer
Requery: Cancer — The study specifically targets palliative care patients with edema and uses the EORTC QLQ C15 PAL questionnaire designed for palliative cancer care patients, indicating a cancer population.
Thinking: non-cancer — Study includes palliative care patients with lower limb edema from any cause including cancer, organ failure, or hypoalbuminemia, making it a mixed population without cancer as primary criterion.
|
non-cancer
Cancer → non-cancer → non-cancer
shaky reasoning✓ Unanimous
Initial: Cancer
Requery: non-cancer — The trial focuses on lymphedema treatment in palliative care patients regardless of etiology, including cancer and non-cancer causes.
Thinking: non-cancer — Eligibility allows any palliative patient with lower-limb edema regardless of cause, not restricted to malignancy.
|
OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient |
inpatient
inpatient → mixed
shaky reasoning✗ No consensus
Initial: inpatient
Requery: mixed — The study explicitly mentions both ambulatory patients managed with absorbent pads and bedridden patients managed with collecting bags, indicating a mix of outpatient and inpatient care settings.
|
inpatient
inpatient → inpatient → outpatient
shaky reasoning✗ No consensus
Initial: inpatient
Requery: inpatient — The study involves palliative care patients with Karnofsky Scale < 50% (indicating severe disability and need for considerable assistance), includes bedridden patients, and mentions collecting data 'on exit' suggesting patients are admitted during the intervention period.
Thinking: outpatient — The trial does not explicitly state patients are hospitalized or admitted during the intervention, and per guidance, default to outpatient when not explicitly stated.
|
outpatient
outpatient → inpatient → inpatient
shaky reasoning✗ No consensus
Initial: outpatient
Requery: inpatient — The study involves palliative care patients, often indicating an inpatient setting, especially since the intervention targets bedridden individuals who are likely hospitalized.
Thinking: inpatient — Daily bedside measurements up to discharge (“exit”) over a 7-day period in very low-Karnofsky palliative patients indicate the intervention is delivered while patients are admitted to a palliative care unit.
|
|
| setting_place | hospital | hospital | hospital | OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | yes | yes | yes | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | yes | yes | yes | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |