Patients Undergoing Lung Surgery Clinical Trial
Official title:
Effect of Complementary and Alternative Medical Methods on the Post Operative Recovery Following Cardio-thoracic Surgery- a Pragmatic, Randomized,Single Blinded, Placebo Controlled Study
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.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | October 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Dptm. Cardio-Thoracic Surgery, Shaare Zedek medical Center | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Shaare Zedek Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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. | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No | |
| Secondary | GI Symptoms | Nausea levels and frequency of vomiting | patients will be evaluated for GI symptoms until discharge (expected average 4 weeks) | No |
| Secondary | Food intake | Duration from surgery to first solid meal | participants will be evaluated for the ingestion of the first solid meal (average: 4 days) | No |
| Secondary | Analgesia Protocol | Analgesics use | daily intake of anlagesic medications will be evaluated each evening throughout the study period (mean expected: 4 weeks) | No |
| Secondary | 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 | No |
| Secondary | Fatigue | 0- 10 scale (0=no fatigue; 10 maximal fatigue) | Daily at 3rd, 4th and 5th post operative days 3,4 and 5 | No |
| Secondary | 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) | No |
| Secondary | Patient Satisfaction | Patient satisfaction questionnaire | at discharge from hospital; expected mean: 4 weeks | No |
| Secondary | Hospitalization costs | At hospital discharge (mean expected: 4 weeks) | No | |
| Secondary | Postoperative complications | Every day, to be evaluated each evening throughout the hospital stay (mean expected: 4 weeks) | No | |
| Secondary | Side-effects | every day; to be evaluated each evening throughout the study period (mean expected: 4 weeks) | No |