MedDataX Logo

CAM in Post Surgical Management in Cardiothoracic Surgery

NCT ID: NCT01650363

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients Undergoing Open Heart Surgery Patients Undergoing Lung Surgery

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Complementary and alternative medicine Post operative recovery Cardio- thoracic surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acupuncture, homeopathy, osteopathy and reflexology

patients will receive combinations of acupuncture, homeopathy, osteopathy and reflexology

Group Type ACTIVE_COMPARATOR

Acupuncture, homeopathy, osteopathy- and reflexology

Intervention Type OTHER

a combination of the above mentioned treatments

homeopathic placebo medication

Group Type PLACEBO_COMPARATOR

Homeopathic placebo medication

Intervention Type DRUG

2-3 mm small spheric suger pils

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acupuncture, homeopathy, osteopathy- and reflexology

a combination of the above mentioned treatments

Intervention Type OTHER

Homeopathic placebo medication

2-3 mm small spheric suger pils

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Menachem Oberbaum

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Menachem Oberbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dptm. Cardio-Thoracic Surgery, Shaare Zedek medical Center

Jerusalem, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Menachem Oberbaum, MD

Role: CONTACT

Phone: +972-2-5555852

Email: [email protected]

Menachem Oberbaum, MD

Role: CONTACT

Phone: +972-2-6666395

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Daniel Fink, MD

Role: primary

Menachem Oberbaum, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTSURG

Identifier Type: -

Identifier Source: org_study_id