Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial

Morten Vester-Andersen; Tina Waldau; Jørn Wetterslev; Morten Hylander Møller; Jacob Rosenberg; Lars Nannestad Jørgensen; Inger Elisabet Gillesberg; Henrik Loft Jakobsen; Egon Godthaab Hansen; Lone Musaeus Poulsen; Jan Skovdal; Ellen Kristine Søgaard; Morten Heiberg Bestle; Jesper Vilandt; Iben Rosenberg; Rasmus Ehrenfried Berthelsen; Jens Højgaard Pedersen; Mogens Rørbæk Madsen; Thomas Feurstein; Malene Just Busse; Johnny Andersen; Christian Maschmann; Morten Rasmussen; Christian Moestrup Jessen; Lasse Bugge; Helle Ording; Ann Møller

doi:10.1186/1745-6215-14-37

Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial

Morten Vester-Andersen, Tina Waldau, Jørn Wetterslev, Morten Hylander Møller, Jacob Rosenberg, Lars Nannestad Jørgensen, Inger Elisabet Gillesberg, Henrik Loft Jakobsen, Egon Godthaab Hansen, Lone Musaeus Poulsen, Jan Skovdal, Ellen Kristine Søgaard, Morten Heiberg Bestle, Jesper Vilandt, Iben Rosenberg, Rasmus Ehrenfried Berthelsen, Jens Højgaard Pedersen, Mogens Rørbæk Madsen, Thomas Feurstein, Malene Just BusseJohnny Andersen, Christian Maschmann, Morten Rasmussen, Christian Moestrup Jessen, Lasse Bugge, Helle Ording, Ann Møller

Department of Clinical Medicine

11 Citations (Scopus)

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.

Original language	English
Journal	Trials
Volume	14
Issue number	1
Pages (from-to)	37
ISSN	1745-6215
DOIs	https://doi.org/10.1186/1745-6215-14-37
Publication status	Published - 2 Feb 2013

Access to Document

10.1186/1745-6215-14-37

Cite this

Vester-Andersen, M., Waldau, T., Wetterslev, J., Møller, M. H., Rosenberg, J., Jørgensen, L. N., Gillesberg, I. E., Jakobsen, H. L., Hansen, E. G., Poulsen, L. M., Skovdal, J., Søgaard, E. K., Bestle, M. H., Vilandt, J., Rosenberg, I., Berthelsen, R. E., Pedersen, J. H., Madsen, M. R., Feurstein, T., ... Møller, A. (2013). Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial. Trials, 14(1), 37. https://doi.org/10.1186/1745-6215-14-37

Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial : study protocol, rationale and feasibility of a randomised multicentre trial. / Vester-Andersen, Morten; Waldau, Tina; Wetterslev, Jørn et al.

In: Trials, Vol. 14, No. 1, 02.02.2013, p. 37.

Research output: Contribution to journal › Journal article › Research › peer-review

Vester-Andersen, M, Waldau, T, Wetterslev, J, Møller, MH , Rosenberg, J , Jørgensen, LN, Gillesberg, IE, Jakobsen, HL, Hansen, EG, Poulsen, LM, Skovdal, J, Søgaard, EK, Bestle, MH, Vilandt, J, Rosenberg, I, Berthelsen, RE, Pedersen, JH, Madsen, MR, Feurstein, T, Busse, MJ, Andersen, J, Maschmann, C, Rasmussen, M, Jessen, CM, Bugge, L, Ording, H & Møller, A 2013, 'Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial', Trials, vol. 14, no. 1, pp. 37. https://doi.org/10.1186/1745-6215-14-37

@article{f07f8656811746e58a78d5b90672b74e,

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 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.",

author = "Morten Vester-Andersen and Tina Waldau and J{\o}rn Wetterslev and M{\o}ller, {Morten Hylander} and Jacob Rosenberg and J{\o}rgensen, {Lars Nannestad} and Gillesberg, {Inger Elisabet} and Jakobsen, {Henrik Loft} and Hansen, {Egon Godthaab} and Poulsen, {Lone Musaeus} and Jan Skovdal and S{\o}gaard, {Ellen Kristine} and Bestle, {Morten Heiberg} and Jesper Vilandt and Iben Rosenberg and Berthelsen, {Rasmus Ehrenfried} and Pedersen, {Jens H{\o}jgaard} and Madsen, {Mogens R{\o}rb{\ae}k} and Thomas Feurstein and Busse, {Malene Just} and Johnny Andersen and Christian Maschmann and Morten Rasmussen and Jessen, {Christian Moestrup} and Lasse Bugge and Helle Ording and Ann M{\o}ller",

year = "2013",

month = feb,

day = "2",

doi = "10.1186/1745-6215-14-37",

language = "English",

volume = "14",

pages = "37",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd.",

number = "1",

}

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 - 2013/2/2

Y1 - 2013/2/2

N2 - 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 - 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

SN - 1745-6215

VL - 14

SP - 37

JO - Trials

JF - Trials

IS - 1

ER -

Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial

Abstract

Access to Document

Fingerprint

Cite this