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 Gillesberg; Henrik Loft Jakobsen; Egon Godthåb Hansen; Lone Musaeus Poulsen; Jan Skovdal; Ellen Kristine Søgaard; Morten Bestle; Jesper Vilandt; Iben Rosenberg; Rasmus Ehrenfried Berthelsen; Jens Pedersen; Mogens Rørbæk Madsen; Thomas Feurstein; Malene Just Busse; Johnny D H Andersen; Christian Maschmann; Morten Rasmussen; Christian Jessen; Lasse Bugge; Helle Ørding; Ann Merete 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 Gillesberg, Henrik Loft Jakobsen, Egon Godthåb Hansen, Lone Musaeus Poulsen, Jan Skovdal, Ellen Kristine Søgaard, Morten Bestle, Jesper Vilandt, Iben Rosenberg, Rasmus Ehrenfried Berthelsen, Jens Pedersen, Mogens Rørbæk Madsen, Thomas Feurstein, Malene Just BusseJohnny D H Andersen, Christian Maschmann, Morten Rasmussen, Christian Jessen, Lasse Bugge, Helle Ørding, Ann Merete Møller

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

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
Pages (from-to)	37
ISSN	1468-6708
DOIs	https://doi.org/10.1186/1745-6215-14-37
Publication status	Published - 2 Feb 2013

Keywords

Clinical Protocols
Emergencies
Feasibility Studies
Humans
Laparoscopy/mortality
Laparotomy/mortality
Postoperative Care

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., Jakobsen, H. L., Hansen, E. G., Poulsen, L. M., Skovdal, J., Søgaard, E. K., Bestle, M., Vilandt, J., Rosenberg, I., Berthelsen, R. E., Pedersen, J., Madsen, M. R., Feurstein, T., ... Møller, A. M. (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, 37. https://doi.org/10.1186/1745-6215-14-37

@article{59070e3f316f4ab59c424532c9054a3a,

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.",

keywords = "Clinical Protocols, Emergencies, Feasibility Studies, Humans, Laparoscopy/mortality, Laparotomy/mortality, Postoperative Care",

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 Inger Gillesberg and Jakobsen, {Henrik Loft} and Hansen, {Egon Godth{\aa}b} and Poulsen, {Lone Musaeus} and Jan Skovdal and S{\o}gaard, {Ellen Kristine} and Morten Bestle and Jesper Vilandt and Iben Rosenberg and Berthelsen, {Rasmus Ehrenfried} and Jens Pedersen and Madsen, {Mogens R{\o}rb{\ae}k} and Thomas Feurstein and Busse, {Malene Just} and Andersen, {Johnny D H} and Christian Maschmann and Morten Rasmussen and Christian Jessen and Lasse Bugge and Helle {\O}rding and M{\o}ller, {Ann Merete}",

year = "2013",

month = feb,

day = "2",

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

language = "English",

volume = "14",

pages = "37",

journal = "Trials",

issn = "1468-6708",

publisher = "BioMed Central Ltd.",

}

Vester-Andersen, M, Waldau, T, Wetterslev, J, Møller, MH, Rosenberg, J, Jørgensen, LN, Gillesberg, I, Jakobsen, HL, Hansen, EG, Poulsen, LM, Skovdal, J, Søgaard, EK, Bestle, M, Vilandt, J, Rosenberg, I, Berthelsen, RE, Pedersen, J, Madsen, MR, Feurstein, T, Busse, MJ, Andersen, JDH, Maschmann, C, Rasmussen, M, Jessen, C, Bugge, L, Ørding, H & Møller, AM 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, pp. 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, 02.02.2013, p. 37.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

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

AU - Jakobsen, Henrik Loft

AU - Hansen, Egon Godthåb

AU - Poulsen, Lone Musaeus

AU - Skovdal, Jan

AU - Søgaard, Ellen Kristine

AU - Bestle, Morten

AU - Vilandt, Jesper

AU - Rosenberg, Iben

AU - Berthelsen, Rasmus Ehrenfried

AU - Pedersen, Jens

AU - Madsen, Mogens Rørbæk

AU - Feurstein, Thomas

AU - Busse, Malene Just

AU - Andersen, Johnny D H

AU - Maschmann, Christian

AU - Rasmussen, Morten

AU - Jessen, Christian

AU - Bugge, Lasse

AU - Ørding, Helle

AU - Møller, Ann Merete

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.

KW - Clinical Protocols

KW - Emergencies

KW - Feasibility Studies

KW - Humans

KW - Laparoscopy/mortality

KW - Laparotomy/mortality

KW - Postoperative Care

U2 - 10.1186/1745-6215-14-37

DO - 10.1186/1745-6215-14-37

M3 - Journal article

C2 - 23374977

SN - 1468-6708

VL - 14

SP - 37

JO - Trials

JF - Trials

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

Keywords

Access to Document

Fingerprint

Cite this