CAM in Post Surgical Management in Cardiothoracic Surgery

Study Overview
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Brief Summary
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This is a randomized controlled clinical trial in which the combination of 4 different CAM modalities (Complementary & Alternative Medicine) will be applied during the postoperative period to patients undergoing open heart- or lung surgery and expected to be hospitalized for more than 5 days. Elective and Urgent surgical patients will be randomly assigned to a treatment - and to a control group. The treatment group will be treated with a combination of 4 different CAM modalities (Homeopathy, Osteopathy, and Acupuncture & Reflexology) . The control group will be treated with Homeopathic placebo medication. The main Outcome measurement in the study will be the Quality of recovery 40 questionnaire (QoR- 40) that will be filled out on postoperative days: 3, 5, and 7 respectively. Secondary outcome measurements will be Blood &Saliva Cortisol levels, DHES levels in the blood as surrogates of stress, IL-2 levels as measures of the immune system. Further parameters to be measured include: LOS (length of stay), Level of Pain, mobility, level of satisfaction, GI symptoms (nausea, first bowel movement), post-operative complications& side effects. All patients participating in the trial will sign an informed consent form . The trial is expected to be conducted over a period of 12 months. Prior to the trial a pilot study will be conducted on a group of 30 patients in order to determine the needed sample size for the trial.

Official Title
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Effect of Complementary and Alternative Medical Methods on the Post Operative Recovery Following Cardio-thoracic Surgery- a Pragmatic, Randomized,Single Blinded, Placebo Controlled Study

Conditions
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Patients Undergoing Open Heart Surgery, Patients Undergoing Lung Surgery

Intervention / Treatment
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* Other: Acupuncture, homeopathy, osteopathy- and reflexology
* Drug: Homeopathic placebo medication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age Patients planned to undergo a surgical procedure which will require an estimated hospitalisation of at least 5 days Patients speaking Hebrew or English Informed Consent signature Exclusion Criteria: patients unable to comply with the study protocol Participation in another clinical trial Thrombocytopenia (< 15.000 for acupuncture treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture, homeopathy, osteopathy and reflexology<br>patients will receive combinations of acupuncture, homeopathy, osteopathy and reflexology | Other: Acupuncture, homeopathy, osteopathy- and reflexology<br>* a combination of the above mentioned treatments<br>|
| Placebo Comparator: homeopathic placebo medication<br> | Drug: Homeopathic placebo medication<br>* 2-3 mm small spheric suger pils<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Quality of Recovery questionnaire-40 (QoR-40) | Quality of Recovery questionnaire is a tool which is used primarily to assess the patient's recovery and state of health following surgery. | days 3,5 and 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress levels | Level of stress will be determined by Dehydroepiandrosterone (DHES) & Cortisol levels in blood and, saliva. | Study entry, 2nd and 3rd day following the treatment initiation. | 
| Immune System Function | - the function of the immune system will be evaluated by measuring IL-2 level on the second and fourth day | 2nd and 4th day after treatment initiation | 
| Length of Stay | Hospitalization duration will be calculated from the first postoperative day. Readiness for discharge will be assessed based on the following measures: Bowel movements and lack of urinary retention yes/no; Ability to dress oneself and move freely; opiate requirement yes/no. Surgical complications requiring further hospitalization yes/no. Readiness for discharge will be based on a 'YES  for the first 2 measures and a no ON THE LAST 2 MEASURES. | patients will be followed for the duration of the hospital stay, an expected average of 4 weeks | 
| First postoperative passage of flatus and first bowel movement. |  | the time to the first passage of flatus and bowel movements, an expected average of 3 days | 
| GI Symptoms | Nausea levels and frequency of vomiting | patients will be evaluated for GI symptoms until discharge (expected average 4 weeks) | 
| Food intake | Duration from surgery to first solid meal | participants will be evaluated for the ingestion of the first solid meal (average: 4 days) | 
| Analgesia Protocol | Analgesics use | daily intake of anlagesic medications will be evaluated each evening throughout the study period (mean expected: 4 weeks) | 
| Pain level estimation | Pain estimation will be based on the NRS scale. The patient will be asked to rate the highest level of pain experienced during the last 24 hrs. | first 3 days and day 6 | 
| Fatigue | 0- 10 scale (0=no fatigue; 10 maximal fatigue) | Daily at 3rd, 4th and 5th post operative days 3,4 and 5 | 
| Ambulation | As ambulant will a patient regarded if he will be able to walk 5 minutes without help | each day participants will be evaluated for ambulation (expected mean: 1 week) | 
| Patient Satisfaction | Patient satisfaction questionnaire | at discharge from hospital; expected mean: 4 weeks | 
| Hospitalization costs |  | At hospital discharge (mean expected: 4 weeks) | 
| Postoperative complications |  | Every day, to be evaluated each evening throughout the hospital stay (mean expected: 4 weeks) | 
| Side-effects |  | every day; to be evaluated each evening throughout the study period (mean expected: 4 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complementary and alternative medicine, Post operative recovery, Cardio- thoracic surgery