Status:
TERMINATED
Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery
Lead Sponsor:
Copenhagen University Hospital at Herlev
Collaborating Sponsors:
University of Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Conditions:
Emergency Abdominal Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 car...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT01209663
Start Date
October 1 2010
End Date
December 1 2012
Last Update
June 24 2015
Active Locations (7)
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1
Copenhagen University, Bispebjerg Hospital
Copenhagen, DK, Denmark, 2400
2
Herning Regional Hospital
Herning, DK, Denmark, 7400
3
Aabenraa Hospital
Aabenraa, Denmark, DK-6200
4
Herlev University Hospital
Copenhagen, Denmark, DK-2730