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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01354-35 | Other Identifier | N° IDRCB |
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| Name | Class |
|---|---|
| Société Francophone d'Onco-Gériatrie | OTHER |
| Federation of Research in Surgery (FRENCH) | OTHER |
| PACAN - Plateforme de Recherche Clinique Patients Agés et Cancer | UNKNOWN |
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Incidence of digestive cancers increase and half of new cases will be people of 75 years or more in 2050. Surgery is one of the main treatment's strategy but post-operative morbi-mortality increases with age. Pre-operative Geriatric Assessment enable to identify frail or vulnerable patients at risk of post-operative complications.
The coordinating team postulate that a geriatric and surgical co-management with a combination of several targeted geriatric interventions with usual post-operative care could improve the post-operative care and decrease the risk of morbi-mortality in older patients with digestive cancers.
Multicenter Randomized Clinical Trial in 2 parallel-groups with masked adjudication of main endpoint
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Co-management arm (geriatric and surgical) | Experimental |
| |
| Usual care | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Co-management | Other | Personalized and intensive geriatric peri-operative care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo | at 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with postoperative complications of each grade in the Clavien-Dindo | at Day 14 and Day 30 | |
| Percentage of patients with each complication among a prespecified list of complication | at Day 14 and Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena PAILLAUD LAURENT PUIG, MD, PhD | Contact | (0)1 56 09 21 64 | +33 | elena.paillaud@aphp.fr |
| Frédérique PESCHAUD, MD, PhD | Contact | (0)1 49 09 53 35 | +33 | frederique.peschaud@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Elena PAILLAUD LAURENT PUIG, MD, PhD | Assistance Publique Hôpitaux de Paris (AP-HP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Paris - Hôpital européen Georges-Pompidou | Paris | 75015 | France |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| Usual care | Other | Pre-operative and post-operative geriatric care as per usual practice |
|
| Social Status | at Day 14 and Day 30 after surgery |
| Activities of Daily Living Scale | at Day 14 and Day 30 after surgery |
| Instrumental Activities of Daily Living Scale | at Day 14 and Day 30 after surgery |
| Mini-Geriatric Depressive Scale | at Day 14 and Day 30 after surgery |
| Mini cognitive scale | at Day 14 and Day 30 after surgery |
| Updated Charlson Comorbidity Index | at Day 14 and Day 30 after surgery |
| Mini Nutritional Assessment-Short Form | at Day 14 and Day 30 after surgery |
| Body mass index | at Day 14 and Day 30 after surgery |
| Timed Up and Go | at Day 14 and Day 30 after surgery |
| Gait speed | at Day 14 and Day 30 after surgery |
| Percentage of patients with cancelled surgeries | at Day 0 to Day 8 |
| Percentage of patients with postponed surgeries | at Day 0 to Day 8 |
| Percentage of patients with complete intervention in the experimental arm | at Day 0 to Day 8 |
| Time of onset of each post-operative complication | at Day 14, Day 30 and Day 90 after surgery |
| Percentage of patients transfered to geriatric unit, intensive care unit, rehabilitation unit or other departement. | at Day 14, Day 30 and Day 90 after surgery |
| Length of stay to geriatric unit, intensive care unit, rehabilitation unit or other departement. | at Day 14, Day 30 and Day 90 after surgery |
| Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - C30) | at Day 30 and Day 90 after surgery |
| Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - ELD14) | at Day 30 and Day 90 after surgery |
| Overall survival | at Day 30 and Day 90 after surgery |
| Length of hospitalizations | at Day 14 after surgery |
| Percentage of patients returned at home or institutionalization | at Day 14, Day 30 and Day 90 after surgery |
| Autonomy (Activities of Daily Living scale) | at Day 14 , Day 30 and Day 90 after surgery |
| Patient and professionals experience (ancillary study using semi-directive interviews) | at Day 30 after surgery |
| D005767 |
| Gastrointestinal Diseases |