Abdominal SurgeryNCT00596778
Chest Physiotherapy on Immediate Postoperative in Patients Submitted to High Abdominal Surgery
A study testing chest physiotherapy in people with Abdominal Surgery and Spirometry, run by University of Sao Paulo.
Trial summary
Abdominal surgical procedures can increase risks of pulmonary complications.The aim of the study was to evaluate the benefits of an early intervention of chest physiotherapy during immediate post-operative in patients submitted to elective abdominal surgery. Read more about this study
- Who is it for?
- Ages 21 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Surgery, Spirometry, Chest Physiotherapy
- What is being tested?
- chest physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Dec 2004
- 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 21 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pre-operative for elective upper abdominal surgery, such as - hernia repair, gall bladder or large bowel removal, exploratory laparotomy, and submitted to general anesthesia or other interventions in abdominal cavity accomplished by conventional laparotomy
Who cannot join
- Patients with indication of liver transplant or bearers of aneurysm of any arterial segment.
- Patients submitted to video-laparoscopy surgery.
About this study
Abdominal surgical procedures can increase risks of pulmonary complications.The aim of the study was to evaluate the benefits of an early intervention of chest physiotherapy during immediate post-operative in patients submitted to elective abdominal surgery.
Read the detailed description
Thirty-one adults were randomly assigned to control and chest physiotherapy groups. Spirometry, pulse oximetry and anamneses were performed before (pre-operative) and in the second post-operative day. Chest physiotherapy group received treatment at the post-anesthesia unit care and control group did not. Chest physiotherapy improved oxygen-hemoglobin saturation in elective post-operative abdominal surgeries.
- Conditions
- Abdominal Surgery, Spirometry, Chest Physiotherapy
- Being tested
- chest physiotherapy
- Keywords
- Physical therapy specialty, Postoperative period. Abdominal surgery, Anesthesia recovery period, Spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest physiotherapyOther
The protocol consisted of breathing exercises during 30 minutes and included: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion.
| Study group | Role | What they receive |
|---|---|---|
| C, CP | Other | Thirty-one adults were randomly assigned to control (C) and chest physiotherapy (CP) groups. Chest physiotherapy group received treatment at the post-anesthesia unit care and control group did not. Receives: Other: chest physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective of chest physiotherapy before and after surgery
Measured: 3 days (before surgery - second post operative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startFeb 2004
- Primary completionDec 2004
- Study completionDec 2004
Why it stopped: terminated
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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596778
- Sponsor's protocol ID
- CAPPesq836/03
- Other IDs
- CAPPesq836/03
- Status last verified
- Jan 2008
- First submitted
- 8 Jan 2008
- Last updated
- 17 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Physiotherapy on Immediate Postoperative in Patients Submitted to High Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00596778
- Acronym / sponsor ID
- CAPPesq836/03
- Conditions
- Abdominal Surgery, Spirometry, Chest Physiotherapy
- Keywords
- Physical therapy specialty, Postoperative period. Abdominal surgery, Anesthesia recovery period, Spirometry
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Feb 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 17 Jan 2008 (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.
Abdominal surgical procedures can increase risks of pulmonary complications.The aim of the study was to evaluate the benefits of an early intervention of chest physiotherapy during immediate post-operative in patients submitted to elective abdominal surgery.
Detailed description
Thirty-one adults were randomly assigned to control and chest physiotherapy groups. Spirometry, pulse oximetry and anamneses were performed before (pre-operative) and in the second post-operative day. Chest physiotherapy group received treatment at the post-anesthesia unit care and control group did not. Chest physiotherapy improved oxygen-hemoglobin saturation in elective post-operative abdominal surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C, CP | Other | Other: chest physiotherapyThirty-one adults were randomly assigned to control (C) and chest physiotherapy (CP) groups. Chest physiotherapy group received treatment at the post-anesthesia unit care and control group did not. |
Who may qualify
- Ages
- 21 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pre-operative for elective upper abdominal surgery, such as - hernia repair, gall bladder or large bowel removal, exploratory laparotomy, and submitted to general anesthesia or other interventions in abdominal cavity accomplished by conventional laparotomy
Key exclusion criteria (2 listed)
- Patients with indication of liver transplant or bearers of aneurysm of any arterial segment.
- Patients submitted to video-laparoscopy surgery.
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 |
|---|---|---|
| chest physiotherapyThe protocol consisted of breathing exercises during 30 minutes and included: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion. | Other | C, CP |
Primary outcome
Effective of chest physiotherapy before and after surgery
Time frame: 3 days (before surgery - second post operative)
Results and safety
The study was stopped early (reason given: terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing chest physiotherapy in people with Abdominal Surgery and Spirometry, run by University of Sao Paulo.
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 2 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: stopped early, as of the sponsor's last update on 17 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: terminated). Results are not available in the source record.
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?
Effective of chest physiotherapy before and after surgery (time frame: 3 days (before surgery - second post operative)). 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 Jan 2008.