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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00632-55 | Other Identifier | ID-RCB number,ANSM |
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| Name | Class |
|---|---|
| Groupement Interrégional de Recherche Clinique et d'Innovation | OTHER |
| Santelys Association | OTHER |
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Major digestive surgery is associated with a significant rate of postoperative complications. To improve postoperative outcome, efforts are focused on postoperative course leading to the concept of rehabilitation. However, the rehabilitation concept does not allow to improve muscular and functional reserves at the time of surgery. Sarcopenia is a condition characterized by loss of skeletal muscle mass and function. Also, the prevalence of sarcopenia in patients with cancer is high and has a prevalence of around 25% in patients with pancreatic cancer, with a considerable impact on postoperative and survival outcomes.
The hypothesis is the preoperative management of sarcopenia by a rehabilitation program could improve patients' operative outcomes by reducing the rate of postoperative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREHAB | Experimental |
| |
| control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation program | Other | 4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative severe pancreatic fistula (Grade B and C) | Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF) | at 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Severe postoperative complications | Grade > IIIa (Clavien-Dindo classification) | at 90 days |
| Overall survival | at 1 year and at 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehdi ELAMRANI, MD | Contact | 0320444465 | +33 | mehdi.elamrani@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mehdi ELAMRANI, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Claude Huriez Chu Lille | Recruiting | Lille | France |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Oral Impact | Dietary Supplement | perioperative immunonutrition by ORAL IMPACT |
|
| Program acceptance measure by Modified ACCEPT© questionnaire | at 30 days |
| Rate of program completion | self questionnaire to measure opinion with respect of rehabilitation program | at 30 days |
| Satisfaction questionnaire by EVAN-G | EVAN-G general patient satisfaction questionnaire consisting of 26 items divided into 6 sub-sections scoring on a scale from 0 to 100. It is designed to report perioperative problems. | at 30 days |
| Satisfaction questionnaire by the questionnaire for satisfaction of hospitalized (QSH-45) | French self-administered instrument for measuring hospitalized patients' satisfaction based on the patient's point of view. QSH contained 45 items describing 9 dimensions, leading to 2 composite scores (staff and structure index) | at 30 days |
| Quality of life by EORTC-QLQc30 scale | The QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The questionnaire includes one global health status/QoL scale, five functional scales and three symptom scale. Each scale is scored from 0 to 100. A high score on a scale indicate a good outcome for the dimension of QoL. | at 1 month, 3 months, 6 months and at 1 year |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |