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CAM in Post Surgical Management in Cardiothoracic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01650363
Recruitment Status : Unknown
Verified July 2012 by Menachem Oberbaum, Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 26, 2012
Last Update Posted : July 26, 2012
Information provided by (Responsible Party):
Menachem Oberbaum, Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Patients Undergoing Open Heart Surgery Patients Undergoing Lung Surgery Other: Acupuncture, homeopathy, osteopathy- and reflexology Drug: Homeopathic placebo medication Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Arm Intervention/treatment
Active Comparator: Acupuncture, homeopathy, osteopathy and reflexology
patients will receive combinations of acupuncture, homeopathy, osteopathy and reflexology
Other: Acupuncture, homeopathy, osteopathy- and reflexology
a combination of the above mentioned treatments

Placebo Comparator: homeopathic placebo medication Drug: Homeopathic placebo medication
2-3 mm small spheric suger pils

Primary Outcome Measures :
  1. Improvement of Quality of Recovery questionnaire-40 (QoR-40) [ Time Frame: 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 Outcome Measures :
  1. Stress levels [ Time Frame: 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.

  2. Immune System Function [ Time Frame: 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

  3. Length of Stay [ Time Frame: 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.

  4. First postoperative passage of flatus and first bowel movement. [ Time Frame: the time to the first passage of flatus and bowel movements, an expected average of 3 days ]
  5. GI Symptoms [ Time Frame: patients will be evaluated for GI symptoms until discharge (expected average 4 weeks) ]
    Nausea levels and frequency of vomiting

  6. Food intake [ Time Frame: participants will be evaluated for the ingestion of the first solid meal (average: 4 days) ]
    Duration from surgery to first solid meal

  7. Analgesia Protocol [ Time Frame: daily intake of anlagesic medications will be evaluated each evening throughout the study period (mean expected: 4 weeks) ]
    Analgesics use

  8. Pain level estimation [ Time Frame: 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.

  9. Fatigue [ Time Frame: Daily at 3rd, 4th and 5th post operative days 3,4 and 5 ]
    0- 10 scale (0=no fatigue; 10 maximal fatigue)

  10. Ambulation [ Time Frame: 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

  11. Patient Satisfaction [ Time Frame: at discharge from hospital; expected mean: 4 weeks ]
    Patient satisfaction questionnaire

  12. Hospitalization costs [ Time Frame: At hospital discharge (mean expected: 4 weeks) ]
  13. Postoperative complications [ Time Frame: Every day, to be evaluated each evening throughout the hospital stay (mean expected: 4 weeks) ]
  14. Side-effects [ Time Frame: every day; to be evaluated each evening throughout the study period (mean expected: 4 weeks) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01650363

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Contact: Menachem Oberbaum, MD +972-2-5555852
Contact: Menachem Oberbaum, MD +972-2-6666395

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Dptm. Cardio-Thoracic Surgery, Shaare Zedek medical Center
Jerusalem, Israel, 91031
Contact: Daniel Fink, MD    +972-2-5555852   
Contact: Menachem Oberbaum, MD    +972-2-6666395   
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Menachem Oberbaum, MD Shaare Zedek Medical Center
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Responsible Party: Menachem Oberbaum, MD, Shaare Zedek Medical Center Identifier: NCT01650363    
Other Study ID Numbers: CTSURG
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: July 2012
Keywords provided by Menachem Oberbaum, Shaare Zedek Medical Center:
Complementary and alternative medicine
Post operative recovery
Cardio- thoracic surgery