Patients Undergoing Open Heart SurgeryPhase 3NCT01650363
CAM in Post Surgical Management in Cardiothoracic Surgery
A Phase 3 study testing Acupuncture, homeopathy, osteopathy- and reflexology in people with Patients Undergoing Open Heart Surgery and Patients Undergoing Lung Surgery, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Open Heart Surgery, Patients Undergoing Lung Surgery
- What is being tested?
- Acupuncture, homeopathy, osteopathy- and reflexology
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2012to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients unable to comply with the study protocol
- Participation in another clinical trial
- Thrombocytopenia (< 15.000 for acupuncture treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site
Dptm. Cardio-Thoracic Surgery, Shaare Zedek medical Center
Jerusalem, 91031
Daniel Fink, MD, +972-2-5555852, dfink@szmc.org.il
Menachem Oberbaum, MD, +972-2-6666395, oberbaum@szmc.org.il
About this study
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
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.
Read more
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.
- Being tested
- Acupuncture, homeopathy, osteopathy- and reflexology, Homeopathic placebo medication
- Keywords
- Complementary and alternative medicine, Post operative recovery, Cardio- thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture, homeopathy, osteopathy- and reflexologyOther
a combination of the above mentioned treatments
Homeopathic placebo medicationDrug
2-3 mm small spheric suger pils
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture, homeopathy, osteopathy and reflexology | Active comparator | patients will receive combinations of acupuncture, homeopathy, osteopathy and reflexology Receives: Other: Acupuncture, homeopathy, osteopathy- and reflexology |
| homeopathic placebo medication | Placebo comparator | Not described Receives: Drug: Homeopathic placebo medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: days 3,5 and 7
Secondary outcomes (14)
Stress levels
Level of stress will be determined by Dehydroepiandrosterone (DHES) \& Cortisol levels in blood and, saliva.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: patients will be evaluated for GI symptoms until discharge (expected average 4 weeks)
Food intake
Duration from surgery to first solid meal
Measured: participants will be evaluated for the ingestion of the first solid meal (average: 4 days)
Analgesia Protocol
Analgesics use
Measured: 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.
Measured: first 3 days and day 6
Fatigue
0- 10 scale (0=no fatigue; 10 maximal fatigue)
Measured: 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
Measured: each day participants will be evaluated for ambulation (expected mean: 1 week)
Patient Satisfaction
Patient satisfaction questionnaire
Measured: at discharge from hospital; expected mean: 4 weeks
Hospitalization costs
Measured: At hospital discharge (mean expected: 4 weeks)
Postoperative complications
Measured: Every day, to be evaluated each evening throughout the hospital stay (mean expected: 4 weeks)
Side-effects
Measured: every day; to be evaluated each evening throughout the study period (mean expected: 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Open Heart SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menachem Oberbaum, Shaare Zedek Medical Center
- Investigators
- Menachem Oberbaum, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650363
- Sponsor's protocol ID
- CTSURG
- Status last verified
- Jul 2012
- First submitted
- 16 Jul 2012
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01650363
- Acronym / sponsor ID
- CTSURG
- Keywords
- Complementary and alternative medicine, Post operative recovery, Cardio- thoracic surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture, homeopathy, osteopathy and reflexology | Active comparator | Other: Acupuncture, homeopathy, osteopathy- and reflexologypatients will receive combinations of acupuncture, homeopathy, osteopathy and reflexology |
| homeopathic placebo medication | Placebo comparator | Drug: Homeopathic placebo medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- patients unable to comply with the study protocol
- Participation in another clinical trial
- Thrombocytopenia (< 15.000 for acupuncture treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture, homeopathy, osteopathy- and reflexologya combination of the above mentioned treatments | Other | Acupuncture, homeopathy, osteopathy and reflexology |
| Homeopathic placebo medication2-3 mm small spheric suger pils | Drug | homeopathic placebo medication |
Primary outcome
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.
14 secondary outcomes
Stress levels
Time frame: Study entry, 2nd and 3rd day following the treatment initiation.
Immune System Function
Time frame: 2nd and 4th day after treatment initiation
Length of Stay
Time frame: 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.
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)
Food intake
Time frame: participants will be evaluated for the ingestion of the first solid meal (average: 4 days)
Analgesia Protocol
Time frame: daily intake of anlagesic medications will be evaluated each evening throughout the study period (mean expected: 4 weeks)
Pain level estimation
Time frame: first 3 days and day 6
Fatigue
Time frame: Daily at 3rd, 4th and 5th post operative days 3,4 and 5
Ambulation
Time frame: each day participants will be evaluated for ambulation (expected mean: 1 week)
Patient Satisfaction
Time frame: at discharge from hospital; expected mean: 4 weeks
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menachem Oberbaum, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupuncture, homeopathy, osteopathy- and reflexology in people with Patients Undergoing Open Heart Surgery and Patients Undergoing Lung Surgery, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Menachem Oberbaum, MD (+972-2-5555852, dfink@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Quality of Recovery questionnaire-40 (QoR-40) (time frame: days 3,5 and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2012.