Clinical trial NCT01650363: CAM in Post Surgical Management in Cardiothoracic Surgery
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Patients Undergoing Open Heart Surgery
Patients Undergoing Lung Surgery
Keywords: Complementary and alternative medicine
Post operative recovery
Cardio- thoracic surgery
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Improvement of Quality of Recovery questionnaire-40 (QoR-40)
timeFrame: days 3,5 and 7
Secondary outcomes:
measure: Stress levels
timeFrame: Study entry, 2nd and 3rd day following the treatment initiation.
measure: Immune System Function
timeFrame: 2nd and 4th day after treatment initiation
measure: Length of Stay
timeFrame: patients will be followed for the duration of the hospital stay, an expected average of 4 weeks
measure: First postoperative passage of flatus and first bowel movement.
timeFrame: the time to the first passage of flatus and bowel movements, an expected average of 3 days
measure: GI Symptoms
timeFrame: patients will be evaluated for GI symptoms until discharge (expected average 4 weeks)
measure: Food intake
timeFrame: participants will be evaluated for the ingestion of the first solid meal (average: 4 days)
measure: Analgesia Protocol
timeFrame: daily intake of anlagesic medications will be evaluated each evening throughout the study period (mean expected: 4 weeks)
measure: Pain level estimation
timeFrame: first 3 days and day 6
measure: Fatigue
timeFrame: Daily at 3rd, 4th and 5th post operative days 3,4 and 5
measure: Ambulation
timeFrame: each day participants will be evaluated for ambulation (expected mean: 1 week)
measure: Patient Satisfaction
timeFrame: at discharge from hospital; expected mean: 4 weeks
measure: Hospitalization costs
timeFrame: At hospital discharge (mean expected: 4 weeks)
measure: Postoperative complications
timeFrame: Every day, to be evaluated each evening throughout the hospital stay (mean expected: 4 weeks)
measure: Side-effects
timeFrame: every day; to be evaluated each evening throughout the study period (mean expected: 4 weeks)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Dptm. Cardio-Thoracic Surgery, Shaare Zedek medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Menachem Oberbaum, MD
role: PRINCIPAL_INVESTIGATOR
References: