Is There a Benefit of Postoperative ICU Management After Elective Surgery in Critical Ill Patients?

Study Overview
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Brief Summary
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Postoperative care of high risk patients in the Intensive Care Unit (ICU) has for long been considered to be the gold standard of care in terms of reducing perioperative mortality.New evidence from a 7-day cohort study involving 27 countries comes to question this practice. The primary objective of our study is to detect any benefit of postoperative ICU care after elective surgery in terms of patient's outcome, length of hospital stay, complications and cost.

Detailed Description
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A prospective analysis of high perioperative risk patients that are about to be subjected into an elective operation will be included into the study. They will be allocated into two groups. Group ICU patients are those that are admitted into the ICU for postoperative care and those that are admitted into a standard ward consist Group Ward. Demographic data, the length of hospital stay, the outcome, the need of mechanical ventilation, the complications and the total cost will be recorded.

Official Title
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Is There a Benefit of Postoperative ICU Management After Elective Surgery in Terms of Patient's Outcome, Length of Hospital Stay, Complications and Cost?

Conditions
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Postoperative Care, Intensive Care

Intervention / Treatment
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* Other: Postoperative care in Intensive care unit (ICU)
* Other: Postoperative care in standard ward


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients that will be scheduled for an elective operation and are considered to be in a high perioperative risk Exclusion Criteria: Patients that are operated on an emergency basis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group I: admitted into the ICU for postoperative care Group II: admitted into a standard ward for postoperative care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group ICU<br>Group ICU:patients are admitted directly into the ICU for postoperative care | Other: Postoperative care in Intensive care unit (ICU)<br>* Postoperative care in Intensive care unit (ICU)<br>|
| Experimental: Group Ward<br>Group Ward:patients are admitted directly into the standard ward for postoperative care | Other: Postoperative care in standard ward<br>* Postoperative care in standard ward<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total length of hospital stay | The total length of patient's hospital stay will be recorded | From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative length of hospital stay | The preoperative length of patient's hospital stay will be recorded | From date of hospital admission until the date of operation or date of death from any cause, whichever came first, assessed up to 6 months | 
| Postoperative length of hospital stay | The postoperative length of patient's hospital stay will be recorded | From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months | 
| Postoperative complications | All postoperative complications will be recorded | From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months | 
| Patient's outcome at 28 days postoperatively | 28 day postoperative mortality will be recorded | From the first postoperative day until 28 days postoperatively | 
| Total cost of hospital care | The total cost of hospital care will be recorded for every patient | From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months | 
| Postoperative cost of hospital care | The postoperative cost of hospital care will be recorded for every patient | From date of surgical operation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive care, postoperative care, elective surgery