Abdominal SurgeryNCT01389648
Pre-operative Physiotherapy to Prevent Post-operative Complications
A study testing Pre Operative in people with Abdominal Surgery, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgery
- What is being tested?
- Pre Operative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to Jul 2012
- Phase
- Interventional
- 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
- Major abdominal surgery
Who cannot join
- Respiratory Disease
- Pregnancy
- Mental Disease
- Dementia
- Alzheimer's Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pre-operative Chest Physiotherapy on Post-operative Complications After Major Abdominal Surgery.
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.
- Conditions
- Abdominal Surgery
- Being tested
- Pre Operative
- Keywords
- adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre OperativeOther
Pre operative chest physiotherapy treatment
| Study group | Role | What they receive |
|---|---|---|
| Pre Operative | Experimental | Pre operative chest physiotherapy treatment Receives: Other: Pre Operative |
| usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory complications
pneumonia, atelectasis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoram Kluger, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389648
- Sponsor's protocol ID
- physiotherapyCTIL
- Status last verified
- Sep 2013
- First submitted
- 6 Jul 2011
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-operative Chest Physiotherapy on Post-operative Complications After Major Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT01389648
- Acronym / sponsor ID
- physiotherapyCTIL
- Conditions
- Abdominal Surgery
- Keywords
- adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Jul 2011 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre Operative | Experimental | Other: Pre OperativePre operative chest physiotherapy treatment |
| usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major abdominal surgery
Key exclusion criteria (5 listed)
- Respiratory Disease
- Pregnancy
- Mental Disease
- Dementia
- Alzheimer's Disease
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 |
|---|---|---|
| Pre OperativePre operative chest physiotherapy treatment | Other | Pre Operative |
Primary outcome
respiratory complications
Time frame: 6 months
pneumonia, atelectasis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
Related trials for Abdominal Surgery
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
Management of Abdominal Post-surgical Scar With Ozoaqua Versus Standard Care
Wound Healing, Abdominal Surgery
Not yet recruiting
Effect of Baduanjin Exercise on Pain, Fatigue, and Quality of Recovery After Abdominal Surgery
Abdominal Surgery, Baduanjin
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.
Yoram Kluger, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre Operative in people with Abdominal Surgery, run by Rambam Health Care Campus 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 17 Sep 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
respiratory complications (time frame: 6 months). 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 17 Sep 2013.