TY - JOUR

T1 - Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial

T2 - study protocol, rationale and feasibility of a randomised multicentre trial

AU - Vester-Andersen, Morten

AU - Waldau, Tina

AU - Wetterslev, Jørn

AU - Møller, Morten Hylander

AU - Rosenberg, Jacob

AU - Jørgensen, Lars Nannestad

AU - Gillesberg, Inger Elisabet

AU - Jakobsen, Henrik Loft

AU - Hansen, Egon Godthaab

AU - Poulsen, Lone Musaeus

AU - Skovdal, Jan

AU - Søgaard, Ellen Kristine

AU - Bestle, Morten Heiberg

AU - Vilandt, Jesper

AU - Rosenberg, Iben

AU - Berthelsen, Rasmus Ehrenfried

AU - Pedersen, Jens Højgaard

AU - Madsen, Mogens Rørbæk

AU - Feurstein, Thomas

AU - Busse, Malene Just

AU - Andersen, Johnny

AU - Maschmann, Christian

AU - Rasmussen, Morten

AU - Jessen, Christian Moestrup

AU - Bugge, Lasse

AU - Ording, Helle

AU - Møller, Ann

PY - 2013

Y1 - 2013

N2 - 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 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.

AB - 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 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.

U2 - 10.1186/1745-6215-14-37

DO - 10.1186/1745-6215-14-37

M3 - Journal article

C2 - 23374977

VL - 14

SP - 37

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

ER -