Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery

Study Overview
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Brief Summary
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The objective of this trial is to evaluate postoperative intermediate care versus ward care in patients who have undergone emergency abdominal surgery with a perioperative Acute Physiology and Chronic Health Evaluation (APACHE) II score ≥ 10 (high risk patients). Patients will be enrolled in the trial, if they are ready to be discharged from the recovery unit or intensive/intermediate care unit to the surgical ward within 24 hours after surgery. Discharge criteria will be according to the Danish national recommendation. The intermediate care bed in the trial is defined by a certain minimum requirements to patient observation and described treatment possibilities which have to be available to the intermediate bed. If the treatment exceeds these treatment possibilities, the patient will be classified as an intensive care patient. The intermediate care bed will be placed at an intensive care unit, recovery unit or a surgical high dependency unit. If there is no available intermediate care bed, the patients will not be randomized, but only registered as excluded because of no available intermediate care bed. Hypothesis: Postoperative intermediate care for 48 hours or more will reduce the 30-day mortality in emergency abdominal surgery patients with a high risk of postoperative organ failure. Interim analysis: An independent Data Monitoring and Safety Committee (DMSC) will conducted the interim analysis based on the analysis of the primary outcome blinded for intervention allocation. The DMSC will use P<0.001 (Haybittle-Peto) on two subsequent interim analyses as the statistical limit to guide its recommendations regarding early termination of the trial for benefit or harm. The first interim analysis will be conducted when the 30 days follow-up data of about 50% (i.e., about 200 patients) of the trial participants have been obtained and/or 75 deaths have been documented during the trial. If P<0,001 in the first interim analysis a second interim analysis will be conducted when the 30 days follow-up data of about 75% (i.e., about 300 patients) of the trial participants have been obtained and/or 25 deaths have been documented during the trial. Trial terminated on the 30th November 2012. The Data Monitor Committee found a very low overall event rate of the primary outcome at the first interim-analysis as compared to the pre-trial estimated. This precluding any possibility to detect or reject the anticipated relative risk reduction of 34 % as used in the sample size estimation.

Detailed Description
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Like Denmark, many European countries has only limited access to surgical intermediate care beds (high dependency beds). This may reflect lack of scientific evidence for the effect of intermediate care combined with restricted healthcare resources. Better access to dedicated postoperative intensive/intermediate care facilities has been suggested as a factor which potentially can reduce postoperative complication rate and mortality in high risk surgical patients. The Incare Trial will provide important data on the effect of postoperative intermediate care in emergency abdominal surgery patients.

Official Title
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Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery

Conditions
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Emergency Abdominal Surgery

Intervention / Treatment
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* Other: Postoperative Intermediate Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Emergency laparotomy patients treated by general surgeons OR Emergency laparoscopic surgery patients treated by general surgeons OR Re-operative patients who go through emergency laparotomy or laparoscopy. AND APACHE II score ≥ 10 AND Patients who are ready to be discharged to the surgical ward after postoperative stay in the recovering unit or an intermediate/intensive care bed Exclusion Criteria: Appendectomy Emergency laparoscopic cholecystectomy Emergency diagnostic laparoscopy without intervention Postoperative stay in the recovery unit or an intermediate/intensive care bed in more then 24 hours before randomization Patients who should not be offered postoperative intensive care Patients who have been included in the study earlier Age < 18 years Trauma patients Because of slower enrolment rate than anticipated the steering committee have decided on the 3rd of May 2012 to include patients with Apache II score of 10 and 11 although the originally inclusion criteria was Apache II score 12 or above. Patients with Apache II score of 10 and 11 have a high 30 day mortality as well and the potential to benefit from intermediate care. The new criteria was initiated on the 23rd of May 2012 after ethical approval was obtained.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ward Care<br>Protocol based discharge to the surgery ward. Observation and treatment is conducted by ward nurses and general surgeons (current treatment). | Other: Postoperative Intermediate Care<br>* Comparison of postoperative Intermediate Care versus Ward Care.<br>* Other names: High dependency unit;|
| Experimental: Intermediate Care<br>Observation and treatment in an intermediate care bed in a minimum of 48 hours after randomization. Daily rounds will be carried out by both general surgeons and intensive care physicians. | Other: Postoperative Intermediate Care<br>* Comparison of postoperative Intermediate Care versus Ward Care.<br>* Other names: High dependency unit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality rate |  | Within 30 days of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long term mortality |  | Until 30 days after the last patient is enrolled in the trial | 
| rate of critical care unit admission from ward |  | Within 30 days of surgery | 
| Postoperative hospitalization time |  | until 30 days after the last patient is enrolled in the trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General Surgery, Emergency treatment, Postoperative care, Intermediate care unit, High dependency unit, Mortality