CAM in Post Surgical Management in Cardiothoracic Surgery

This study is not yet open for participant recruitment.
Verified July 2012 by Shaare Zedek Medical Center
Sponsor:
Information provided by (Responsible Party):
Menachem Oberbaum, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01650363
First received: July 16, 2012
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Improvement of Quality of Recovery questionnaire-40 (QoR-40) [ Time Frame: days 3,5 and 7 ] [ Designated as safety issue: No ]
    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:
  • Stress levels [ Time Frame: Study entry, 2nd and 3rd day following the treatment initiation. ] [ Designated as safety issue: No ]
    Level of stress will be determined by Dehydroepiandrosterone (DHES) & Cortisol levels in blood and, saliva.

  • Immune System Function [ Time Frame: 2nd and 4th day after treatment initiation ] [ Designated as safety issue: No ]
    - the function of the immune system will be evaluated by measuring IL-2 level on the second and fourth day

  • Length of Stay [ Time Frame: patients will be followed for the duration of the hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]

    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. [ Time Frame: the time to the first passage of flatus and bowel movements, an expected average of 3 days ] [ Designated as safety issue: No ]
  • GI Symptoms [ Time Frame: patients will be evaluated for GI symptoms until discharge (expected average 4 weeks) ] [ Designated as safety issue: No ]
    Nausea levels and frequency of vomiting

  • Food intake [ Time Frame: participants will be evaluated for the ingestion of the first solid meal (average: 4 days) ] [ Designated as safety issue: No ]
    Duration from surgery to first solid meal

  • Analgesia Protocol [ Time Frame: daily intake of anlagesic medications will be evaluated each evening throughout the study period (mean expected: 4 weeks) ] [ Designated as safety issue: No ]
    Analgesics use

  • Pain level estimation [ Time Frame: first 3 days and day 6 ] [ Designated as safety issue: No ]
    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.

  • Fatigue [ Time Frame: Daily at 3rd, 4th and 5th post operative days 3,4 and 5 ] [ Designated as safety issue: No ]
    0- 10 scale (0=no fatigue; 10 maximal fatigue)

  • Ambulation [ Time Frame: each day participants will be evaluated for ambulation (expected mean: 1 week) ] [ Designated as safety issue: No ]
    As ambulant will a patient regarded if he will be able to walk 5 minutes without help

  • Patient Satisfaction [ Time Frame: at discharge from hospital; expected mean: 4 weeks ] [ Designated as safety issue: No ]
    Patient satisfaction questionnaire

  • Hospitalization costs [ Time Frame: At hospital discharge (mean expected: 4 weeks) ] [ Designated as safety issue: No ]
  • Postoperative complications [ Time Frame: Every day, to be evaluated each evening throughout the hospital stay (mean expected: 4 weeks) ] [ Designated as safety issue: No ]
  • Side-effects [ Time Frame: every day; to be evaluated each evening throughout the study period (mean expected: 4 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650363

Contacts
Contact: Menachem Oberbaum, MD +972-2-5555852 dfink@szmc.org.il
Contact: Menachem Oberbaum, MD +972-2-6666395 oberbaum@szmc.org.il

Locations
Israel
Dptm. Cardio-Thoracic Surgery, Shaare Zedek medical Center Not yet recruiting
Jerusalem, Israel, 91031
Contact: Daniel Fink, MD    +972-2-5555852    dfink@szmc.org.il   
Contact: Menachem Oberbaum, MD    +972-2-6666395    oberbaum@szmc.org.il   
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Menachem Oberbaum, MD Shaare Zedek Medical Center
  More Information

No publications provided

Responsible Party: Menachem Oberbaum, MD, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01650363     History of Changes
Other Study ID Numbers: CTSURG
Study First Received: July 16, 2012
Last Updated: July 23, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Shaare Zedek Medical Center:
Complementary and alternative medicine
Post operative recovery
Cardio- thoracic surgery

ClinicalTrials.gov processed this record on April 16, 2014