CAM in Post Surgical Management in Cardiothoracic Surgery
|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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
- 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.
- 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 ]
- GI Symptoms [ Time Frame: patients will be evaluated for GI symptoms until discharge (expected average 4 weeks) ]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) ]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) ]Analgesics use
- 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.
- 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)
- 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
- Patient Satisfaction [ Time Frame: at discharge from hospital; expected mean: 4 weeks ]Patient satisfaction questionnaire
- Hospitalization costs [ Time Frame: At hospital discharge (mean expected: 4 weeks) ]
- Postoperative complications [ Time Frame: Every day, to be evaluated each evening throughout the hospital stay (mean expected: 4 weeks) ]
- Side-effects [ Time Frame: every day; to be evaluated each evening throughout the study period (mean expected: 4 weeks) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650363
|Contact: Menachem Oberbaum, MDfirstname.lastname@example.org|
|Contact: Menachem Oberbaum, MDemail@example.com|
|Dptm. Cardio-Thoracic Surgery, Shaare Zedek medical Center||Not yet recruiting|
|Jerusalem, Israel, 91031|
|Contact: Daniel Fink, MD +972-2-5555852 firstname.lastname@example.org|
|Contact: Menachem Oberbaum, MD +972-2-6666395 email@example.com|
|Principal Investigator:||Menachem Oberbaum, MD||Shaare Zedek Medical Center|