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NCT04498208 · ClinicalTrials.gov registry record · NA

Immune Modulation by Enhanced vs Standard Prehabilitation Program Before Major Surgery

A NA study, sponsored by Stanford University.

Completed
Registry status
NA
Development phase
55
Enrollment target

NCT04498208: Completed NA study, sponsored by Stanford University.

NCT04498208 is a NA study that has completed, run by Stanford University. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04498208, a NA study, has completed, sponsored by Stanford University.

COMPLETED
Registry status
NA
Development phase
55 participants
Enrollment target

Study Summary

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.

Primary Outcome

Composite immunological score containing a combination of blood immune cell frequencies and intracellular signaling responses. This score will be normalized to "baseline" (i.e. before prehabilitation) score for each patient.

Interventions

  • BEHAVIORAL Physical Prehabilitation
  • BEHAVIORAL Stress Reduction Prehabilitation
  • BEHAVIORAL Cognitive Prehabilitation
  • BEHAVIORAL Nutrition Prehabilitation

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2020-10-07
Est. Completion 2024-04-21
Phase NA
Stanford University

1,744 total trials

What the finished NCT04498208 record still lists

NCT04498208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 4 interventions - of which Physical Prehabilitation is the first listed.

NCT04498208 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04498208 about?

NCT04498208 is a clinical study titled "Immune Modulation by Enhanced vs Standard Prehabilitation Program Before Major Surgery". 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 t...

What is the current status of trial NCT04498208?

This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2020-10-07. Estimated completion is 2024-04-21.

What interventions are being tested in trial NCT04498208?

The interventions under investigation include: Physical Prehabilitation (BEHAVIORAL), Stress Reduction Prehabilitation (BEHAVIORAL), Cognitive Prehabilitation (BEHAVIORAL), Nutrition Prehabilitation (BEHAVIORAL).

Who is sponsoring clinical trial NCT04498208?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04498208's enrollment target sits among peer trials

55 1264th of 2000 higher than 733 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04498208, the US trial registry maintained by the National Library of Medicine. NCT04498208 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.