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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
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Surgery focused on measuring adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 6, 2011
Last Updated
September 15, 2013
Sponsor
Rambam Health Care Campus
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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

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Pre-operative Physiotherapy to Prevent Post-operative Complications

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