Dataset Information

Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial: study protocol for a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery.

ABSTRACT:

Introduction

Postoperative morbidity and mortality in patients undergoing major emergency gastrointestinal surgery are a major burden on healthcare systems. Optimal management of perioperative intravenous fluids may reduce mortality rates and improve outcomes from surgery. Previous small trials of cardiac-output guided haemodynamic therapy algorithms in patients undergoing gastrointestinal surgery have suggested this intervention results in reduced complications and a modest reduction in mortality. However, this existing evidence is based mainly on elective (planned) surgery, with little evaluation in the emergency setting. There are fundamental clinical and pathophysiological differences between the planned and emergency surgical setting which may influence the effects of this intervention. A large definitive trial in emergency surgery is needed to confirm or refute the potential benefits observed in elective surgery and to inform widespread clinical practice.

Methods

The FLO-ELA trial is a multi-centre, parallel-group, open, randomised controlled trial. 3138 patients aged 50 and over undergoing major emergency gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid, or usual care without cardiac output monitoring. The trial intervention will be carried out during surgery and for up to 6 h postoperatively. The trial is funded through an efficient design call by the National Institute for Health and Care Research Health Technology Assessment (NIHR HTA) programme and uses existing routinely collected datasets for the majority of data collection. The primary outcome is the number of days alive and out of hospital within 90 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation. Participant recruitment started in September 2017 with a 1-year internal pilot phase and is ongoing at the time of publication.

Discussion

This will be the largest contemporary randomised trial examining the effectiveness of perioperative cardiac output-guided haemodynamic therapy in patients undergoing major emergency gastrointestinal surgery. The multi-centre design and broad inclusion criteria support the external validity of the trial. Although the clinical teams delivering the trial interventions will not be blinded, significant trial outcome measures are objective and not subject to detection bias.

Trial registration

ISRCTN 14729158. Registered on 02 May 2017.

SUBMITTER: Edwards MR

PROVIDER: S-EPMC10163929 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial: study protocol for a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery.

Edwards Mark R MR Forbes Gordon G Walker Neil N Morton Dion G DG Mythen Monty G MG Murray Dave D Anderson Iain I Mihaylova Borislava B Thomson Ann A Taylor Matt M Hollyman Marianne M Phillips Rachel R Young Keith K Kahan Brennan C BC Pearse Rupert M RM Grocott Michael P W MPW

Trials 20230506 1

<h4>Introduction</h4>Postoperative morbidity and mortality in patients undergoing major emergency gastrointestinal surgery are a major burden on healthcare systems. Optimal management of perioperative intravenous fluids may reduce mortality rates and improve outcomes from surgery. Previous small trials of cardiac-output guided haemodynamic therapy algorithms in patients undergoing gastrointestinal surgery have suggested this intervention results in reduced complications and a modest reduction in ...[more]

PMID: 37149623

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Project description:IntroductionThe optimal closure of the abdominal wall after emergency midline laparotomy is still a matter of debate due to lack of evidence. Although closure of the fascia using a continuous, all-layer suture technique with slowly absorbable monofilament material is common, complications like burst abdomen and hernia are frequent.Methods and analysisThis randomised controlled trial with a 1:1 allocation evaluates the efficacy and safety of a continuous suture with or without additional interrupted retention sutures for closure of the abdominal fascia. Patients with an indication for a primary emergency midline laparotomy are eligible to participate in this study and will be randomised intraoperatively via block randomisation. Fascia closure in the intervention group will be done with a standard continuous suture with slowly absorbable monofilament material (MonoMax 1, B. Braun, Tuttlingen, Germany) and additional interrupted retention sutures every 2 cm of the fascia using rapidly absorbable braided material (Vicryl 2, Ethicon, Norderstedt, Germany). In the control group, the fascia is closed only with the standard continuous suture with slowly absorbable monofilament material. Sample size calculations (n=111 per study arm) are based on the available literature. The primary endpoint is the rate of dehiscence of the abdominal fascia (rate of burst abdomen within 30 days or rate of incisional hernia within 12 months). Secondary endpoints are wound infections, quality of life, length of hospital stay, morbidity and mortality. Patients as well as individuals involved in data collection, endpoint assessment, data analysis and quality of life assessment will be blinded.Ethics and disseminationThe study protocol, the patient information and the informed consent form have been approved by the ethics committee of the Ludwig-Maximilians-University, Munich, Germany (reference number: 20-1041). Study findings will be submitted for publication in peer-reviewed journals.Trial registration numberDRKS00024802.Who universal trial numberU1111-1259-1956.

Project description:IntroductionPostoperative morbidity and mortality in older patients with comorbidities undergoing gastrointestinal surgery are a major burden on healthcare systems. Infections after surgery are common in such patients, prolonging hospitalisation and reducing postoperative short-term and long-term survival. Optimal management of perioperative intravenous fluids and inotropic drugs may reduce infection rates and improve outcomes from surgery. Previous small trials of cardiac-output-guided haemodynamic therapy algorithms suggested a modest reduction in postoperative morbidity. A large definitive trial is needed to confirm or refute this and inform widespread clinical practice.MethodsThe Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial is a multicentre, international, parallel group, open, randomised controlled trial. 2502 high-risk patients undergoing major elective gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intravenous fluid combined with low-dose inotrope infusion, or usual care. The trial intervention will be carried out during and for 4 hours after surgery. The primary outcome is postoperative infection of Clavien-Dindo grade II or higher within 30 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation; however, outcome assessors will be blinded when feasible. Participant recruitment started in January 2017 and is scheduled to last 3 years, within 50 hospitals worldwide.Ethics/disseminationThe OPTIMISE II trial has been approved by the UK National Research Ethics Service and has been approved by responsible ethics committees in all participating countries. The findings will be disseminated through publication in a widely accessible peer-reviewed scientific journal.Trial registration numberISRCTN39653756.

Project description:BackgroundPatients with liver cirrhosis undergoing liver transplantation have a hyperdynamic circulation which persists into the early postoperative period making accurate assessment of fluid requirements challenging. Goal-directed fluid therapy (GDFT) has been shown to reduce morbidity and mortality in a number of surgery settings. The impact of GDFT in patients undergoing liver transplantation is unknown. A feasibility trial was designed to determine patient and clinician support for recruitment into a randomised controlled trial of GDFT following liver transplantation, adherence to a GDFT protocol, participant withdrawal, and to determine appropriate endpoints for a subsequent larger trial to evaluate the efficacy of GDFT in patients undergoing liver transplantation.MethodsThe Cardiac output Optimisation following Liver Transplant (COLT) trial is designed as a prospective, single-centre, randomised controlled study to assess the feasibility and safety of GDFT in liver transplantation for patients with cirrhosis. Consenting adults (aged between 18 and 80 years) with biopsy-proven liver cirrhosis who have been selected to undergo a first liver transplantation will be included in the trial and randomised into GDFT or standard care starting immediately after surgery and continuing for the first 12 h thereafter. Both groups will have cardiac output and stroke volume monitored using the FloTrac (EV1000) device. The intervention will consist of a protocolised GDFT approach to patient management, using stroke volume optimisation. The control group will receive standard care, without stroke volume and cardiac output measurement. After 12 h the patient's fluid management will revert to standard of care. The primary endpoint of this study is feasibility. Secondary endpoints will include a safety assessment of the intervention, graft and patient survival, liver function, postoperative complications graded by Clavien-Dindo criteria, length of intensive care and hospital stay and quality of life across the intervention and control groups.DiscussionThere is a growing body of evidence that the use of perioperative GDFT in surgical patients can improve outcomes; however, signals of harm have also been detected. Patients with liver cirrhosis undergoing liver transplantation have markedly different cardiovascular physiology than general surgical patients. If GDFT is proven to be feasible and safe in this patient group, then a multicentre trial to demonstrate efficacy and cost-effectiveness will be required.Trial registrationInternational Standard Randomised Controlled Trial Registry, ID: ISRCTN10329248. Registered on 4 April 2016.

Project description:Past studies have highlighted variation in in-hospital mortality rates among hospitals performing emergency laparotomy for large bowel perforation. The aim of this study was to investigate whether failure to rescue (FTR) contributes to this variability. Patients aged 18 years or over requiring surgery for large bowel perforation between 2013 and 2016 were extracted from the National Emergency Laparotomy Audit (NELA) database. Information on complications were identified using linked Hospital Episode Statistics data and in-hospital deaths from the Office for National Statistics. The FTR rate was defined as the proportion of patients dying in hospital with a recorded complication, and was examined in hospitals grouped as having low, medium or high overall postoperative mortality. Overall, 6413 patients were included with 1029 (16.0 per cent) in-hospital deaths. Some 3533 patients (55.1 per cent) had at least one complication: 1023 surgical (16.0 per cent) and 3332 medical (52.0 per cent) complications. There were 22 in-hospital deaths following a surgical complication alone, 685 deaths following a medical complication alone, 150 deaths following both a surgical and medical complication, and 172 deaths with no recorded complication. The risk of in-hospital death was high among patients who suffered either type of complication (857 deaths in 3533 patients; FTR rate 24.3 per cent): 172 deaths followed a surgical complication (FTR-surgical rate 16.8 per cent) and 835 deaths followed a medical complication (FTR-medical rate of 25.1 per cent). After adjustment for patient characteristics and hospital factors, hospitals grouped as having low, medium or high overall postoperative mortality did not have different FTR rates (P = 0.770). Among patients having emergency laparotomy for large bowel perforation, efforts to reduce the risk of in-hospital death should focus on reducing avoidable complications. There was no evidence of variation in FTR rates across National Health Service hospitals in England.

Project description:BackgroundEmergency laparotomy (EL) is a central, high-risk procedure in emergency surgery. Patients in need of an EL present an acute pathology in the abdomen that must be operated on in order to save their lives. Usually, the underlying condition produces an affected physiology. The perioperative management of this critically ill patient group in need of high-risk surgery and anaesthesia is challenging and related to high mortality worldwide. However, outcomes in Sweden have yet to be studied. This retrospective cohort study explores the perioperative management and outcome after 710 ELs by investigating mortality, overall length of stay (LOS) in hospital, need for care at the intensive care unit (ICU), surgical complications and a general review of perioperative management.MethodsMedical records after laparotomy was retrospectively analysed for a period of 38 months (2014-2017), the emergency cases were included. Children (< 18 years), aortic surgery, second look and other expected reoperations were excluded. Demographic, management and outcome data were collected after an extensive analysis of the cohort.ResultsA total of 710 consecutive operations, representing 663 patients, were included in the cohort (mean age 65.6 years). Mortality (30 days/1 year) after all operations was 14.2% and 26.6% respectively. The mean LOS in hospital was 12 days, while LOS in the ICU was five days. Of all operations, 23.8% patients were admitted at any time to the ICU postoperatively and the 30-day mortality seen among ICU patients was 37.9%. Mortality was strongly correlated to existing comorbidity, high ASA classification, ICU care and faecal peritonitis. The mean/median time from notification to operate until the first incision was 3:46/3:02 h and 87% of patients had their first incision within 6 h of notification.ConclusionsIn this present Swedish study, high mortality and morbidity were observed after emergency laparotomy, which is in agreement with other recent studies.Trial registrationThe study has been registered with ClinicalTrials.gov (NCT03549624, registered 8 June 2018).

Project description:BackgroundHigh-level evidence regarding the technique of abdominal wall closure for patients undergoing emergency midline laparotomy is sparse. Therefore, we conducted a randomized controlled trial (RCT) to evaluate the efficacy and safety of two commonly applied abdominal wall closure strategies after primary emergency midline laparotomy.Methods/designCONTINT was a multi-center pragmatic open-label exploratory randomized controlled parallel trial. Two different abdominal wall closure strategies in patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity were compared: the continuous, all-layer suture and the interrupted suture technique. The primary composite endpoint was burst abdomen within 30 days after surgery or incisional hernia within 12 months. As reliable data on this composite primary endpoint were not available for patients undergoing emergency surgery, it was planned to initially recruit 80 patients and conduct an interim analysis after these had completed the 12 months follow-up.ResultsFrom August 31, 2009, to June 28, 2012, 124 patients were randomized of whom 119 underwent surgery and were analyzed according to the intention-to-treat (ITT) principal. The primary composite endpoint did not differ between the continuous suture (C: 27.1%) and the interrupted suture group (I: 30.0%). None of the individual components of the primary endpoint (reoperation due to burst abdomen after 30 days (C: 13.5%, I: 15.1%) and reoperation due to incisional hernia (C: 3.0%, I:11.1%)) differed between groups. Time needed for fascial closure was longer in the interrupted suture group (C: 12.8 ± 4.5 min, I: 17.4 ± 6.1 min). BMI was associated with burst abdomen during the first 30 days with an OR of 1.17 (95% CI 1.04-1.32).ConclusionThis RCT showed no difference between continuous suture with slowly absorbable suture versus interrupted rapidly absorbable sutures after primary emergency midline laparotomy in rates of postoperative burst abdomen and incisional hernia after one year. However, the trial was stopped after the interim analysis due to futility as there was no chance to show superiority of one suture technique.

Dataset Information

Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial: study protocol for a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery.

Introduction

Methods

Discussion

Trial registration

Publications

Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial: study protocol for a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery.

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