Pre-operative Physiotherapy to Prevent Post-operative Complications
Primary Purpose
Abdominal Surgery
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Pre Operative
Sponsored by
About this trial
This is an interventional prevention trial for Abdominal Surgery focused on measuring adult
Eligibility Criteria
Inclusion Criteria:
- Major abdominal surgery
Exclusion Criteria:
- Respiratory Disease
- Pregnancy
- Mental Disease
- Dementia
- Alzheimer's Disease
Sites / Locations
- Rambam Health Care Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pre Operative
usual care
Arm Description
Pre operative chest physiotherapy treatment
Outcomes
Primary Outcome Measures
respiratory complications
pneumonia, atelectasis
Secondary Outcome Measures
Full Information
NCT ID
NCT01389648
First Posted
July 6, 2011
Last Updated
September 15, 2013
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT01389648
Brief Title
Pre-operative Physiotherapy to Prevent Post-operative Complications
Official Title
The Effect of Pre-operative Chest Physiotherapy on Post-operative Complications After Major Abdominal Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the roll of pre-operative chest physiotherapy, in addition to the usual care given after major abdominal surgery, in the prevention of post-operative respiratory complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Surgery
Keywords
adult
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre Operative
Arm Type
Experimental
Arm Description
Pre operative chest physiotherapy treatment
Arm Title
usual care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Pre Operative
Intervention Description
Pre operative chest physiotherapy treatment
Primary Outcome Measure Information:
Title
respiratory complications
Description
pneumonia, atelectasis
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major abdominal surgery
Exclusion Criteria:
Respiratory Disease
Pregnancy
Mental Disease
Dementia
Alzheimer's Disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoram Kluger, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Pre-operative Physiotherapy to Prevent Post-operative Complications
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