Immune Modulation by Enhanced vs Standard Prehabilitation Program Before Major Surgery

Not Recruiting

Trial ID: NCT04498208

Purpose

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.

Official Title

Immune System Modulation by Enhanced vs Standard Prehabilitation Program in Patients Undergoing Elective Major Surgery - a Prospective Monocentric Randomized Single-blinded Controlled Trial

Stanford Investigator(s)

Brice Gaudilliere
Brice Gaudilliere

Associate Professor of Anesthesiology, Perioperative and Pain Medicine (Adult-MSD) and, by courtesy, of Pediatrics (Neonatology)

Cindy Kin, MD, MS, FACS, FASCRS
Cindy Kin, MD, MS, FACS, FASCRS

Associate Professor of Surgery (General Surgery)

Martin S. Angst
Martin S. Angst

Professor of Anesthesiology, Perioperative and Pain Medicine

Eligibility

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

Intervention(s):

behavioral: Physical Prehabilitation

behavioral: Stress Reduction Prehabilitation

behavioral: Cognitive Prehabilitation

behavioral: Nutrition Prehabilitation

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Brice Gaudilliere
617-230-5927