Trial record 7 of 19 for:    Open Studies | homeopathy

CAM in Post Surgical Management in Cardiothoracic Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
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
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, see Learn About Clinical Studies.

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 July 23, 2014