Patients Undergoing Lung Surgery, Patients Undergoing Open Heart Surgery
Conditions
Keywords
Complementary and alternative medicine, Post operative recovery, Cardio- thoracic surgery
Brief summary
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.
Interventions
OTHERAcupuncture, homeopathy, osteopathy- and reflexology
a combination of the above mentioned treatments
DRUGHomeopathic placebo medication
2-3 mm small spheric suger pils
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Quality of Recovery questionnaire-40 (QoR-40) | days 3,5 and 7 | Quality of Recovery questionnaire is a tool which is used primarily to assess the patient's recovery and state of health following surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune System Function | 2nd and 4th day after treatment initiation | \- the function of the immune system will be evaluated by measuring IL-2 level on the second and fourth day |
| Length of Stay | patients will be followed for the duration of the hospital stay, an expected average of 4 weeks | 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. |
| 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 | patients will be evaluated for GI symptoms until discharge (expected average 4 weeks) | Nausea levels and frequency of vomiting |
| Food intake | participants will be evaluated for the ingestion of the first solid meal (average: 4 days) | Duration from surgery to first solid meal |
| Analgesia Protocol | daily intake of anlagesic medications will be evaluated each evening throughout the study period (mean expected: 4 weeks) | Analgesics use |
| Stress levels | Study entry, 2nd and 3rd day following the treatment initiation. | Level of stress will be determined by Dehydroepiandrosterone (DHES) & Cortisol levels in blood and, saliva. |
| Fatigue | Daily at 3rd, 4th and 5th post operative days 3,4 and 5 | 0- 10 scale (0=no fatigue; 10 maximal fatigue) |
| Ambulation | each day participants will be evaluated for ambulation (expected mean: 1 week) | As ambulant will a patient regarded if he will be able to walk 5 minutes without help |
| Patient Satisfaction | at discharge from hospital; expected mean: 4 weeks | Patient satisfaction questionnaire |
| 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) | — |
| Pain level estimation | first 3 days and day 6 | 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. |
Countries
Israel
Contacts
Primary ContactMenachem Oberbaum, MD
Backup ContactMenachem Oberbaum, MD
Outcome results
None listed