Study protocol
Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial
1 Department of Anaesthesiology and Intensive Care Medicine, Herlev Hospital, Copenhagen University, Herlev Ringvej 75, DK-2730, Herlev, Denmark
2 Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
3 Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
4 Department of Surgery, Herlev Hospital, Copenhagen University, Herlev, Denmark
5 Department of Surgery, Bispebjerg Hospital, Copenhagen University, Copenhagen, Denmark
6 Department of Anaesthesiology, Koege Hospital, Copenhagen University, Koege, Denmark
7 Department of Surgery, Koege Hospital, Copenhagen University, Koege, Denmark
8 Department of Anaesthesiology, Hilleroed Hospital, Copenhagen University, Hilleroed, Denmark
9 Department of Surgery, Hilleroed Hospital, Copenhagen University, Hilleroed, Denmark
10 Department of Anaesthesiology, Herning Regional Hospital, Herning, Denmark
11 Department of Surgery, Herning Regional Hospital, Herning, Denmark
12 Department of Anaesthesiology, Hospital of Southern Jutland Aabenraa, Aabenraa, Denmark
13 Department of Surgery, Hospital of Southern Jutland Aabenraa, Aabenraa, Denmark
14 Department of Anaesthesiology, Bispebjerg Hospital, Copenhagen University, Copenhagen, Denmark
15 Department of Anaesthesiology, Hospital Lillebaelt Vejle, Vejle, Denmark
16 Department of Surgery, Hospital Lillebaelt Vejle, Vejle, Denmark
Trials 2013, 14:37 doi:10.1186/1745-6215-14-37
Published: 2 February 2013Abstract
Background
Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients.
Methods and design
The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power.
Discussion
This trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care.
Trial registration
Clinicaltrials.gov identifier: NCT01209663
