Hans Bahlmann1, Ingvar Halldestam, Lena Nilsson. 1. From the Department of Medical and Health Sciences and Department of Anaesthesiology and Intensive Care (HB, LN), and the Department of Clinical and Experimental Medicine and Department of Surgery, Linköping University, University Hospital, Linköping, Sweden (IH).
Abstract
BACKGROUND:Goal-directed therapy (GDT) is expected to be of highest benefit in high-risk surgery. Therefore, GDT is recommended during oesophageal resection, which carries a high risk of postoperative complications. OBJECTIVES: The aim of this study was to confirm the hypothesis that GDT during oesophageal resection improves outcome compared with standard care. DESIGN: A randomised controlled study. SETTING:Two Swedish university hospitals, between October 2011 and October 2015. PATIENTS: Sixty-four patients scheduled for elective transthoracic oesophageal resection were randomised. Exclusion criteria included colonic interposition and significant aortic or mitral valve insufficiency. INTERVENTION: A three-step GDT protocol included stroke volume optimisation using colloid boluses as assessed by pulse-contour analysis, dobutamine infusion if cardiac index was below 2.5 l min m and norepinephrine infusion if mean arterial blood pressure was below 65 mmHg. MAIN OUTCOME MEASURE: The incidence of complications per patient at 5 and 30 days postoperatively as assessed using a predefined list. RESULTS: Fifty-nine patients were available for analysis. Patients in the intervention group received more colloid fluid (2190 ± 875 vs. 1596 ± 759 ml, P < 0.01) and dobutamine more frequently (27/30 vs. 9/29, P < 0.01). The median [interquartile range, IQR] incidence of complications per patient 5 days after surgery was 2 [0 to 3] in the intervention group and 1 [0 to 2] in the control group (P = 0.10), and after 30 days 4 [2 to 6] in the intervention group and 2 [1 to 4] in the control group (P = 0.10). CONCLUSION: Goal-directed therapy during oesophageal resection did not result in a reduction of the incidence of postoperative complications. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01416077.
RCT Entities:
BACKGROUND: Goal-directed therapy (GDT) is expected to be of highest benefit in high-risk surgery. Therefore, GDT is recommended during oesophageal resection, which carries a high risk of postoperative complications. OBJECTIVES: The aim of this study was to confirm the hypothesis that GDT during oesophageal resection improves outcome compared with standard care. DESIGN: A randomised controlled study. SETTING: Two Swedish university hospitals, between October 2011 and October 2015. PATIENTS: Sixty-four patients scheduled for elective transthoracic oesophageal resection were randomised. Exclusion criteria included colonic interposition and significant aortic or mitral valve insufficiency. INTERVENTION: A three-step GDT protocol included stroke volume optimisation using colloid boluses as assessed by pulse-contour analysis, dobutamine infusion if cardiac index was below 2.5 l min m and norepinephrine infusion if mean arterial blood pressure was below 65 mmHg. MAIN OUTCOME MEASURE: The incidence of complications per patient at 5 and 30 days postoperatively as assessed using a predefined list. RESULTS: Fifty-nine patients were available for analysis. Patients in the intervention group received more colloid fluid (2190 ± 875 vs. 1596 ± 759 ml, P < 0.01) and dobutamine more frequently (27/30 vs. 9/29, P < 0.01). The median [interquartile range, IQR] incidence of complications per patient 5 days after surgery was 2 [0 to 3] in the intervention group and 1 [0 to 2] in the control group (P = 0.10), and after 30 days 4 [2 to 6] in the intervention group and 2 [1 to 4] in the control group (P = 0.10). CONCLUSION: Goal-directed therapy during oesophageal resection did not result in a reduction of the incidence of postoperative complications. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01416077.
Authors: Blanca Tapia; Elena Garrido; Jose Luis Cebrian; Jose Luis Del Castillo; Javier Gonzalez; Itsaso Losantos; Fernando Gilsanz Journal: Cancers (Basel) Date: 2021-03-27 Impact factor: 6.639