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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
158
4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support
perioperative immunonutrition by ORAL IMPACT
Hop Claude Huriez Chu Lille
Lille, France
RECRUITINGPost-operative severe pancreatic fistula (Grade B and C)
Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF)
Time frame: at 90 days
Rate of Severe postoperative complications
Grade \> IIIa (Clavien-Dindo classification)
Time frame: at 90 days
Overall survival
Time frame: at 1 year and at 3 years
Program acceptance measure by Modified ACCEPT© questionnaire
Time frame: at 30 days
Rate of program completion
self questionnaire to measure opinion with respect of rehabilitation program
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: at 1 month, 3 months, 6 months and at 1 year
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