title: Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinicaltrials.gov identifier: NCT01209663.
authors: Department of Anaesthesiology and Intensive Care Medicine, Herlev Hospital, Copenhagen University, Herlev Ringvej 75, DK-2730 Herlev, Denmark. drvester@dadlnet.dk
authors: Morten
authors: M
authors: Vester-Andersen
authors: Tina
authors: T
authors: Waldau
authors: Jørn
authors: J
authors: Wetterslev
authors: Morten Hylander
authors: MH
authors: Møller
authors: Jacob
authors: J
authors: Rosenberg
authors: Lars Nannestad
authors: LN
authors: Jørgensen
authors: Inger
authors: I
authors: Gillesberg
authors: Henrik Loft
authors: HL
authors: Jakobsen
authors: Egon Godthåb
authors: EG
authors: Hansen
authors: Lone Musaeus
authors: LM
authors: Poulsen
authors: Jan
authors: J
authors: Skovdal
authors: Ellen Kristine
authors: EK
authors: Søgaard
authors: Morten
authors: M
authors: Bestle
authors: Jesper
authors: J
authors: Vilandt
authors: Iben
authors: I
authors: Rosenberg
authors: Rasmus Ehrenfried
authors: RE
authors: Berthelsen
authors: Jens
authors: J
authors: Pedersen
authors: Mogens Rørbæk
authors: MR
authors: Madsen
authors: Thomas
authors: T
authors: Feurstein
authors: Malene Just
authors: MJ
authors: Busse
authors: Johnny D H
authors: JD
authors: Andersen
authors: Christian
authors: C
authors: Maschmann
authors: Morten
authors: M
authors: Rasmussen
authors: Christian
authors: C
authors: Jessen
authors: Lasse
authors: L
authors: Bugge
authors: Helle
authors: H
authors: Ørding
authors: Ann Merete
authors: AM
authors: Møller
mesh_terms: D002985:Clinical Protocols; D004630:Emergencies; D005240:Feasibility Studies; D006801:Humans; D010535:Laparoscopy / Q000401:mortality*; D007813:Laparotomy / Q000401:mortality*; D011182:Postoperative Care
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