Post-operative Adhesion(s)PoISNCT02894788
Postoperative Intensive Care Surveillance
An observational study of Post-operative Adhesion(s), run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Several score systems were created to stratify perioperative risk and predict mortality. The study rises from the needing of a rapid and simple system to identify the patient worthy of Postoperative Intensive Surveillance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Adhesion(s)
- What is being tested?
- ICU admission
- How many people
- 2,498 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2015to Sep 2015
- Phase
- Observational
- 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
Study population: surgical population
Who may be able to join
- elective surgery
Who cannot join
- multiple surgery
- age less than 18
Trial locations and contacts
1 site in 1 country.
Italy1 site
Humanitas Research Hospital - Dept. Anesthesia and Intensive Care Unit
Rozzano, Milano, 20089
About this study
Official title: POSTOPERATIVE INTENSIVE CARE SURVEILLANCE. A Tool to Optimize ICU-beds Management?
Several score systems were created to stratify perioperative risk and predict mortality. The study rises from the needing of a rapid and simple system to identify the patient worthy of Postoperative Intensive Surveillance. In the first phase Authors retrospectively investigated on patients underwent to elective surgery searching for determining factors (DFs) for postoperative ICU admission. Later, Researchers prospectively studied how DFs could predict the admission in ICU of consecutive patients scheduled for elective surgery during a three-months period and created an index, named PoIS (Post-operative Intensive Surveillance), based on the results of this analysis. Authors used surgical invasiveness (SI), Diabetes Mellitus (DM), Myocardiopathy (MCP), Cerebrovascular Disease (CVD), Body Mass Index (BMI), age, serum creatinine level (sCr), Tiffenau Index (TI) and male sex for the development of the original model. Authors classified SI from G1 (lowest) to G5 (highest).
The results show that the power of prediction of postoperative morbidity of PoIS and POSSUM resulted coincident and better than the American Society of Anesthesiology scoring system.
- Conditions
- Post-operative Adhesion(s)
- Being tested
- ICU admission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU admissionOther
| Study group | Role | What they receive |
|---|---|---|
| ICU | patients postoperatively admitted to ICU Receives: Other: ICU admission | |
| no ICU | patients who didn't required ICU admission postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative intensive care surveillance scoring system
Measured: 1 hour after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startMar 2015
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Adhesion(s)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894788
- Sponsor's protocol ID
- PoIS
- Acronym
- PoIS
- Status last verified
- Sep 2016
- First submitted
- 19 Jul 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POSTOPERATIVE INTENSIVE CARE SURVEILLANCE. A Tool to Optimize ICU-beds Management?
- ClinicalTrials.gov ID
- NCT02894788
- Acronym / sponsor ID
- PoIS / PoIS
- Conditions
- Post-operative Adhesion(s)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,498 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Sep 2016 (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.
Several score systems were created to stratify perioperative risk and predict mortality. The study rises from the needing of a rapid and simple system to identify the patient worthy of Postoperative Intensive Surveillance. In the first phase Authors retrospectively investigated on patients underwent to elective surgery searching for determining factors (DFs) for postoperative ICU admission. Later, Researchers prospectively studied how DFs could predict the admission in ICU of consecutive patients scheduled for elective surgery during a three-months period and created an index, named PoIS (Post-operative Intensive Surveillance), based on the results of this analysis. Authors used surgical invasiveness (SI), Diabetes Mellitus (DM), Myocardiopathy (MCP), Cerebrovascular Disease (CVD), Body Mass Index (BMI), age, serum creatinine level (sCr), Tiffenau Index (TI) and male sex for the development of the original model. Authors classified SI from G1 (lowest) to G5 (highest).
The results show that the power of prediction of postoperative morbidity of PoIS and POSSUM resulted coincident and better than the American Society of Anesthesiology scoring system.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU | – | Other: ICU admissionpatients postoperatively admitted to ICU |
| no ICU | – | –patients who didn't required ICU admission postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- surgical population
Key inclusion criteria (1 listed)
- elective surgery
Key exclusion criteria (2 listed)
- multiple surgery
- age less than 18
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 |
|---|---|---|
| ICU admission | Other | ICU |
Primary outcome
Post-operative intensive care surveillance scoring system
Time frame: 1 hour after the end of surgery
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 9 Sep 2016.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Adhesion(s), run by Istituto Clinico Humanitas at 1 site in Italy.
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: finished, as of the sponsor's last update on 9 Sep 2016. 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 Italy. 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?
Post-operative intensive care surveillance scoring system (time frame: 1 hour after the end of surgery). 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 9 Sep 2016.