Complex Peri-operative Intervention in Older Patients With Cancer
- Conditions
- Digestive Cancer
- Interventions
- Other: Co-managementOther: Usual care
- Registration Number
- NCT04709055
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
- Detailed Description
Multicenter Randomized Clinical Trial in 2 parallel-groups with masked adjudication of main endpoint
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 630
- Aged 75 years or more
- Gastric, colo-rectal, pancreatic cancer or hepatic metastasis needed a surgical treatment
- Health Insurance
- At risk of post-operative complication through Surgical Risk Calculator (>25%) or surgeon judgment.
- Written consent
- Surgery in emergency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Co-management arm (geriatric and surgical) Co-management - Usual care Usual care -
- Primary Outcome Measures
Name Time Method Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo at 30 days after surgery
- Secondary Outcome Measures
Name Time Method Social Status at Day 14 and Day 30 after surgery Mini cognitive scale at Day 14 and Day 30 after surgery Percentage of patients with postoperative complications of each grade in the Clavien-Dindo at Day 14 and Day 30 Mini-Geriatric Depressive Scale at Day 14 and Day 30 after surgery Updated Charlson Comorbidity Index at Day 14 and Day 30 after surgery Body mass index at Day 14 and Day 30 after surgery Instrumental Activities of Daily Living Scale at Day 14 and Day 30 after surgery Percentage of patients with each complication among a prespecified list of complication at Day 14 and Day 30 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 Activities of Daily Living Scale at Day 14 and Day 30 after surgery Mini Nutritional Assessment-Short Form at Day 14 and Day 30 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 Overall survival at Day 30 and Day 90 after surgery Percentage of patients with postponed surgeries 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 Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - C30) at Day 30 and Day 90 after surgery Patient and professionals experience (ancillary study using semi-directive interviews) at Day 30 after surgery Percentage of patients with complete intervention in the experimental arm at Day 0 to Day 8 Percentage of patients returned at home or institutionalization at Day 14, 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 Length of hospitalizations at Day 14 after surgery Autonomy (Activities of Daily Living scale) at Day 14 , Day 30 and Day 90 after surgery
Trial Locations
- Locations (1)
Assistance Publique Hôpitaux de Paris - Hôpital européen Georges-Pompidou
🇫🇷Paris, France