Randomized multicentre feasibility trial of intermediate care versus standard ward care after emergency abdominal surgery (InCare trial)

TY - JOUR

T1 - Randomized multicentre feasibility trial of intermediate care versus standard ward care after emergency abdominal surgery (InCare trial)

AU - Vester-Andersen, M

AU - Waldau, T

AU - Wetterslev, J

AU - Møller, M H

AU - Rosenberg, J

AU - Jørgensen, Lars Nannestad

AU - Jakobsen, J C

AU - Møller, A M

AU - InCare trial group

N1 - © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd.

PY - 2015/5/1

Y1 - 2015/5/1

N2 - Background Emergency abdominal surgery carries a considerable risk of death and postoperative complications. Early detection and timely management of complications may reduce mortality. The aim was to evaluate the effect and feasibility of intermediate care compared with standard ward care in patients who had emergency abdominal surgery. Methods This was a randomized clinical trial carried out in seven Danish hospitals. Eligible for inclusion were patients with an Acute Physiology And Chronic Health Evaluation (APACHE) II score of at least 10 who were ready to be transferred to the surgical ward within 24-h of emergency abdominal surgery. Participants were randomized to either intermediate care or standard surgical ward care after surgery. The primary outcome was 30-day mortality. Results In total, 286 patients were included in the modified intention-to-treat analysis. The trial was terminated after the interim analysis owing to slow recruitment and a lower than expected mortality rate. Eleven (7·6 per cent) of 144 patients assigned to intermediate care and 12 (8·5 per cent) of 142 patients assigned to ward care died within 30 days of surgery (odds ratio 0·91, 95 per cent c.i. 0·38 to 2·16; P-=-0·828). Thirty (20·8 per cent) of 144 patients assigned to intermediate care and 37 (26·1 per cent) of 142 assigned to ward care died within the total observation period (hazard ratio 0·78, 95 per cent c.i. 0·48 to 1·26; P-=-0·310). Conclusion Postoperative intermediate care had no statistically significant effect on 30-day mortality after emergency abdominal surgery, nor any effect on secondary outcomes. The trial was stopped prematurely owing to slow recruitment and a much lower than expected mortality rate among the enrolled patients. Registration number: NCT01209663 (http://www.clinicaltrials.gov).

AB - Background Emergency abdominal surgery carries a considerable risk of death and postoperative complications. Early detection and timely management of complications may reduce mortality. The aim was to evaluate the effect and feasibility of intermediate care compared with standard ward care in patients who had emergency abdominal surgery. Methods This was a randomized clinical trial carried out in seven Danish hospitals. Eligible for inclusion were patients with an Acute Physiology And Chronic Health Evaluation (APACHE) II score of at least 10 who were ready to be transferred to the surgical ward within 24-h of emergency abdominal surgery. Participants were randomized to either intermediate care or standard surgical ward care after surgery. The primary outcome was 30-day mortality. Results In total, 286 patients were included in the modified intention-to-treat analysis. The trial was terminated after the interim analysis owing to slow recruitment and a lower than expected mortality rate. Eleven (7·6 per cent) of 144 patients assigned to intermediate care and 12 (8·5 per cent) of 142 patients assigned to ward care died within 30 days of surgery (odds ratio 0·91, 95 per cent c.i. 0·38 to 2·16; P-=-0·828). Thirty (20·8 per cent) of 144 patients assigned to intermediate care and 37 (26·1 per cent) of 142 assigned to ward care died within the total observation period (hazard ratio 0·78, 95 per cent c.i. 0·48 to 1·26; P-=-0·310). Conclusion Postoperative intermediate care had no statistically significant effect on 30-day mortality after emergency abdominal surgery, nor any effect on secondary outcomes. The trial was stopped prematurely owing to slow recruitment and a much lower than expected mortality rate among the enrolled patients. Registration number: NCT01209663 (http://www.clinicaltrials.gov).

KW - Aged

KW - Aged, 80 and over

KW - Denmark

KW - Digestive System Surgical Procedures

KW - Disease Management

KW - Emergencies

KW - Emergency Service, Hospital

KW - Feasibility Studies

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Postoperative Care

KW - Postoperative Complications

KW - Retrospective Studies

KW - Survival Rate

U2 - 10.1002/bjs.9749

DO - 10.1002/bjs.9749

M3 - Journal article

C2 - 25789827

SN - 0007-1323

VL - 102

SP - 619

EP - 629

JO - British Journal of Surgery

JF - British Journal of Surgery

IS - 6

ER -