Immune System Modulation by Enhanced vs Standard Prehabilitation Program in Patients Undergoing Elective Major Surgery - a Prospective Monocentric Randomized Single-blinded Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Composite immunological score
研究概览
简要总结
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.
详细描述
The study design is a prospective monocenter single-blinded randomized controlled trial in patients undergoing elective major abdominal surgery.
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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.
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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.
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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
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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.
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Surgery (Day S)
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Post operative period
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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.
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Immunological status will be assessed at Day S+1 by blood draw.
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Cognitive function, neuropathic pain and quality of life will be assessed at Day S + 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Personalized prehabilitation
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
干预措施: Nutrition Prehabilitation (Behavioral)
Personalized prehabilitation
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
干预措施: Physical Prehabilitation (Behavioral)
Personalized prehabilitation
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
干预措施: Stress Reduction Prehabilitation (Behavioral)
Personalized prehabilitation
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
干预措施: Cognitive Prehabilitation (Behavioral)
Standard prehabilitation
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.
结局指标
主要结局
Composite immunological score
时间窗: immediately preoperatively
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.
次要结局
- Timed Up and Go Test(immediately preoperatively)
- Hospital length of stay(30 days after surgery)
- Pain Catastrophizing Scale(immediately preoperatively)
- Postoperative pain(Postoperatively through to 7 days after surgery)
- Five Times Sit to Stand Test(immediately preoperatively)
- Changes in diet(immediately preoperatively)
- Changes in cognitive functions(immediately preoperatively)
- Incidence of postoperative complications(Postoperatively through to 30 days after surgery)
- Cumulative opioid consumption(Postoperatively through to day 7)
- Neuropathic pain(30 days after surgery)
- Changes in quality of life(30 days after surgery)
- Proportion of compliant patients(immediately preoperatively)
- Wall Squat Test(immediately preoperatively)
- Body Mass Index(immediately preoperatively)
- Amsterdam Preoperative Anxiety and Information Scale(immediately preoperatively)
- 6 Min Walk Test(immediately preoperatively)
研究者
Brice Gaudilliere
Principal Investigator
Stanford University