CAM in Post Surgical Management in Cardiothoracic Surgery

Effect of Complementary and Alternative Medical Methods on the Post Operative Recovery Following Cardio-thoracic Surgery- a Pragmatic, Randomized,Single Blinded, Placebo Controlled Study

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.

Study Overview

• Status: Unknown
• Conditions: Patients Undergoing Open Heart Surgery; Patients Undergoing Lung Surgery
• Intervention / Treatment: Other: Acupuncture, homeopathy, osteopathy- and reflexology; Drug: Homeopathic placebo medication

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91031
    • Dptm. Cardio-Thoracic Surgery, Shaare Zedek medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Quality of Recovery questionnaire-40 (QoR-40)	Quality of Recovery questionnaire is a tool which is used primarily to assess the patient's recovery and state of health following surgery.	days 3,5 and 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress levels	Level of stress will be determined by Dehydroepiandrosterone (DHES) & Cortisol levels in blood and, saliva.	Study entry, 2nd and 3rd day following the treatment initiation.
Immune System Function	- the function of the immune system will be evaluated by measuring IL-2 level on the second and fourth day	2nd and 4th day after treatment initiation
Length of Stay	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.	patients will be followed for the duration of the hospital stay, an expected average of 4 weeks
First postoperative passage of flatus and first bowel movement.		the time to the first passage of flatus and bowel movements, an expected average of 3 days
GI Symptoms	Nausea levels and frequency of vomiting	patients will be evaluated for GI symptoms until discharge (expected average 4 weeks)
Food intake	Duration from surgery to first solid meal	participants will be evaluated for the ingestion of the first solid meal (average: 4 days)
Analgesia Protocol	Analgesics use	daily intake of anlagesic medications will be evaluated each evening throughout the study period (mean expected: 4 weeks)
Pain level estimation	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.	first 3 days and day 6
Fatigue	0- 10 scale (0=no fatigue; 10 maximal fatigue)	Daily at 3rd, 4th and 5th post operative days 3,4 and 5
Ambulation	As ambulant will a patient regarded if he will be able to walk 5 minutes without help	each day participants will be evaluated for ambulation (expected mean: 1 week)
Patient Satisfaction	Patient satisfaction questionnaire	at discharge from hospital; expected mean: 4 weeks
Hospitalization costs		At hospital discharge (mean expected: 4 weeks)
Postoperative complications		Every day, to be evaluated each evening throughout the hospital stay (mean expected: 4 weeks)
Side-effects		every day; to be evaluated each evening throughout the study period (mean expected: 4 weeks)

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Principal Investigator: Menachem Oberbaum, MD, Shaare Zedek Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): October 1, 2013

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 23, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Estimate): July 26, 2012
• Last Update Submitted That Met QC Criteria: July 23, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Complementary and alternative medicine; Post operative recovery; Cardio- thoracic surgery
• Other Study ID Numbers: CTSURG