Immune Modulation by Enhanced vs Standard Prehabilitation Program Before Major Surgery

Stanford University

Status: Completed

Conditions: Gastrointestinal Disease; Urological Disease; Immune System and Related Disorders; Surgery; Preoperative Care; Thoracic Diseases; Gynecologic Disease

Treatments: Behavioral: Cognitive Prehabilitation; Behavioral: Stress Reduction Prehabilitation; Behavioral: Physical Prehabilitation; Behavioral: Nutrition Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04498208

IRB-57570

Details and patient eligibility

About

Over 30 million surgeries are performed annually in the US. Up to 30% of surgical patients experience delayed surgical recovery, marked by prolonged post-surgical pain, opioid consumption, and functional impairment, which contributes $8 billion annually to US health care costs. Novel interventions that improve the resolution of pain, minimize opioid exposure, and accelerate functional recovery after surgery are urgently needed.

Multi-modal pre-operative optimization programs (or "prehab") integrating exercise, nutrition, and stress reduction have been shown to safely and effectively improve outcomes after surgery. However, no objective biological markers assess prehab effectiveness and are able to tailor prehab programs to individual patients. Surgery is a profound immunological perturbation, during which a complex network of innate and adaptive immune cells is mobilized to organize the recovery process of wound healing, tissue repair, and pain resolution. As such, the in-depth assessment of a patient's immune system before surgery is a promising approach to tailor prehab programs to modifiable biological markers associated with surgical recovery. The primary goal of this clinical trial is to determine the effect of a personalized prehab program on patients immunological status before surgery.

Full description

The study design is a prospective monocenter single-blinded randomized controlled trial in patients undergoing elective major abdominal surgery.

• Patients will be recruited during the surgical consultation, at least 14 days prior to surgery. If they choose to enroll, they will undergo randomization on the day of enrollment.

• Prehabilitation (Day 0): personalized or standard prehabilitation program will be proposed to the patients for a period of 2 to 6 weeks. Immunological, nutritional, physical, cognitive, anxiety and quality of life status will be quantified at baseline by previously trained personnel.

• From the beginning (Day 0) to the end of the prehabilitation program (Day 14 to Day 42): every 7 days, a compliance questionnaire will be filled by phone, by a trained member of the research team blinded to the treatment arm of the study

• End of the prehabilitation period (Day 14 to Day 42): Immunological, nutritional, physical, cognitive and anxiety status after prehabilitation will be recorded by a trained member of the research team blinded to the treatment arm of the study.

• Surgery (Day S)

• Post operative period

  • From Day S (2 hours after surgery end) to discharge from the hospital, length of stay, pain and adverse clinical events will be measured and recorded.
  • Immunological status will be assessed at Day S+1 by blood draw.
  • Cognitive function, neuropathic pain and quality of life will be assessed at Day S + 30.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (≥ 18 years)
• Competent to provide informed consent
• Undergoing major elective surgery under general anesthesia in ≥14 days from enrollment (abdominal, thoracic, plastic and neurosurgeries).
• Fluent in English

Exclusion criteria

• Premorbid conditions or orthopedic impairments with contraindications to exercise
• Cognitive disabilities defined as evolutive neurological or neurodegenerative disease
• ASA score 4 or higher or patient under palliative care
• Illiteracy (inability to read the English language).
• Expected length of stay at hospital < 48 hours
• Patient under tutorship or curatorship
• Pregnant or breast-feeding woman
• Absence of informed consent or request to not participate to the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 2 patient groups

Personalized prehabilitation

Experimental group

Description:

Patients will participate in a personalized health optimization program combining one-on-one coaching, tailored to each patient's physical, nutritional, well-being and cognitive status baseline. Prehabilitation will last from a minimum of 14 days to a maximum of 42 days before surgery

Treatment:

Behavioral: Nutrition Prehabilitation

Behavioral: Cognitive Prehabilitation

Behavioral: Physical Prehabilitation

Behavioral: Stress Reduction Prehabilitation

Standard prehabilitation

No Intervention group

Description:

Patients in the control group will be provided with standard instructions in a hard-copy form specific to prehabilitation before surgery associating physical, nutritional, stress-reduction and cognitive recommendations without any personalized coaching for at least 14 days prior to surgery.