Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer (PSOAS)

University Hospital, Lille

Status: Enrolling

Conditions: Sarcopenia; Pancreatic Cancer

Treatments: Dietary Supplement: Oral Impact; Other: Prehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT04469504

2019-A00632-55 (Other Identifier)

2017_06

Details and patient eligibility

About

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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing pancreaticoduodenectomy for cancer
• Sarcopenic status

Exclusion criteria

• Age younger than 18 years
• Medical contraindications including cardiovascular disease or clinically significant vascular disease
• Physical inability to exercise
• Emergent surgery

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 2 patient groups

PREHAB

Experimental group

Treatment:

Other: Prehabilitation program

control group

Active Comparator group

Treatment:

Dietary Supplement: Oral Impact