ENCORE trial (Effects of aNesthesia in COloREctal cancer outcome trial) The effects of anaesthetic techniques on time to start of adjuvant chemotherapy, and early- and late outcomes following surgery for colorectal cancer. A prospective, multicenter, international, observational, pragmatic study.

The main objective of this international, observational study is to determine if anaesthesia technique (epidural vs no epidural or inhalational vs total intravenous) or surgical technique (laparoscopic vs open surgery) has any benefits for patients in term of the earlier start of adjuvant chemotherapy and improved short- or long-term outcomes in patients undergoing surgery for colorectal cancer (stage I-III).

Chief Investigator

Prof. Max Bell (Associate Professor, Senior Lecturer, Department of Perioperative Medicine and Surgical services, Karolinska University Hospital, Solna, Sweden; Department of Physiology and Pharmacology, Karolinska Institutet)

Timeline

Call for centre: Ongoing
Recruitment of patients: Foreseen for 2021
Join the Study

This study will include as many participating institutions as possible across the world. It is planned to recruit at least 10,000 patients.

Would your hospital like to join this study as an actively contributing research centre? The ‘Call for Centres form’ must be filled in online. The completion of this form will facilitate coordination and is mandatory for participation in ESAIC CTN. ESAIC Secretariat will then contact you, providing you with additional information. Please visit the call for centres page.

A prospective multi-centre international observational study of postoperative vasopressor use

To evaluate the proportion of non-cardiac surgical patients receiving postoperative vasopressors.
To evaluate the characteristics of patients, surgery and anaesthesia that lead to postoperative vasopressor use.
To evaluate the incidence of organ injury in patients who receive postoperative vasopressors
To evaluate the variability in postoperative vasopressor use across healthcare environments.
Chief Investigators

Dr. Ib JAMMER (Haukeland University Hospital – Bergen, Norway)
Dr. Ben Creagh-Brown (Royal Surrey County Hospital NHS Foundation Trust – Guildford
d, United Kingdom)
Timeline

Open enrollment: Recruiting centres
Recruiting patients from autumn 2020
Join the Study

This study will include as many participating institutions as possible across the world

The Study is entirely sponsored by a grant from the European Society of Anaesthesiology and Intensive Care Clinical Trial Network (ESAIC CTN). The aim of the European Society of Anaesthesiology and Intensive Care Clinical Trial Network is to provide an infrastructure for clinical research in the fields of Anaesthesia, Pain, Intensive Care and Emergency Medicine by transnational European collaborative studies.

The study is endorsed by the European Society of Intensive Care Medicine (ESICM).

The ‘Call for Centres form’ must be filled in online. The completion of this form will facilitate coordination and is mandatory for participation in ESAIC CTN. ESAIC Secretariat will then contact you, providing you with additional information. Please visit the call for centres page.

Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury

EPIS-AKI is an international multi-center, prospective observational study with the aim to include 10,000 patients to clarify the incidence and circumstances of the occurrence of acute kidney injury in patients undergoing major surgery.

Chief Investigators

Alexander Zarbock
Department of Anesthesiology, Intensive Care and Pain Medicine
University Hospital Münster, Münster
Germany

Timeline

Open enrollment: Recruiting centres

Recruiting patients from autumn 2020

Join the Study

Supported by:

RAPNetwork (Renoprotective Network) supported by the European Society of Anesthesiology

EAGLE is an international quality improvement programme consisting of online training modules for surgeons and theatre teams. The aim is to share best practice with the goal of reducing the anastomotic leak rate.

EAGLE Study design key points

EAGLE will evaluate the implementation of the ESCP Safe Anastomosis Quality Improvement Intervention.
EAGLE is an international, multi-centre, cluster randomised-sequence service improvement study, with the hospital as the cluster.
Any hospital or surgical unit performing elective and/or emergency colorectal surgery may participate.
Adults (age 18 years and above) undergoing right colectomy or ileocaecal resection for any indication will be enrolled in EAGLE (including elective, expedited or emergency surgery by open, laparoscopic or robotic approaches).
The primary outcome is the 30-day overall anastomotic leak rate, defined as clinical or radiologically detected anastomotic leak or intra-abdominal or pelvic collection.
Chief Investigators

Dion Morton (Head of Global Research at ESCP) and Professor Charles Knowles (Research Committee Chair at ESCP).

Timeline

Open enrollment: Recruiting centres and patients

Recruiting patients from autumn 2020

Join the Study

eagle@contacts.bham.ac.uk

Supported by:

European Society of Coloproctology

Multicentre, multidisciplinary registry of perioperative/periprocedural management of antithrombotic drugs. In short, the aim is to collect the management of these drugs in the “real world”, and to assess the impact of the consensus document published last year. The aim would be to include anticoagulated and/or antiplatelet patients undergoing an intervention and to record the management of these drugs and collect bleeding/ischaemic events 30 days after intervention

Chief Investigators

David Vivas, Hospital Clinico San Carlos, Madrid

Timeline

Open enrollment: Recruiting centres and patients

Recruiting patients from autumn 2020

Join the Study:

dvivas@secardiologia.es

Supported by:

Spanish Society of Cardiology

BigpAK-2 Study (Biomarker-guided intervention to prevent acute kidney injury after major non-cardiac surgery)

BigpAK-2 Study is an international, multicenter, randomized, controlled interventional trial, with 1302 patients undergoing major non-cardiac surgery.

The objective is to investigate whether the strict implementation of the KDIGO bundle can reduce the incidence of AKI amongst high risk patients in this population (with risk stratification via Nephrocheck).

Primary Endpoint:

Occurrence of moderate or severe AKI (according to the KDIGO criteria) within 3 days after surgery

Secondary Endpoints:

Adherence to the implementation of the KDIGO bundle (the implementation of the different measures for different time frames)

Occurrence and severity of AKI within 3 days after major non-cardiac surgery

Change in biomarker values after 12 hours after initial measurement of [TIMP-2]*[IGFBP7]

Free-days of mechanical ventilation through day 3

Free days of vasopressors through day 3

Need of RRT at days 30 and 90

Duration of RRT at days 30 and 90

Renal recovery at day 90, defined as:

complete recovery: serum creatinine ≤ 0.5 mg/dl higher than baseline
partial recovery: serum creatinine > 0.5 mg/dl higher than baseline but no dialysis-dependence
Chief Investigators

niv.-Prof. Dr. med. A. Zarbock
University Hospital Muenster
Department of Anesthesiology, Intensive Care and Pain Medicine Albert-Schweitzer-Campus 1, A1
48149 Muenster
Germany

Timeline

Open enrollment: Recruiting centres and patients

Recruiting patients from autumn 2020

Study Contact:

E-mail: aki@anit.uni-muenster.de

coMpliAnce with evideNce-based cliniCal guidelines in the managemenT of acute biliaRy pancreAtitis (MANCTRA-1).

Although several guidelines have been published for the management of the patient with acute biliary pancreatitis, compliance with these has generally been generally unsatisfactory, with reports of several shortcomings and lack of standardization of the management of acute pancreatitis worldwide.

Through a large-scale international multicenter retrospective analysis large-scale retrospective analysis, MANCTRA-1 can identify a number of clinical deficits and, through their their analysis, lead to improvements in the quality of care. The study aims to summarize the main areas of sub-optimal care due to lack of compliance with current guidelines, to provide the basis for the introduction of a series of bundles in the management of patients with acute biliary pancreatitis to be implemented in the coming years.

Chief Investigator

Dr. Mauro Podda, M.D.
Department of Emergency Surgery, Azienda Ospedaliero-Universitaria di Cagliari, University Hospital Policlinico Duilio Casula, Cagliari, Italy.
mauropodda@ymail.com

Timeline

Call for centres: Ongoing
Recruitment of patients: ongoing
Study Objectives

Primary outcomes
30-day mortality: assessed by the number of AP patients with biliary etiology deceased during the non-pandemic period (2019) and the Covid-19 pandemic period (2020)
30-day morbidity: assessed by the number of AP patients with biliary etiology who experienced any type of AP-related complication within 30-days from the hospital admission during the non-pandemic period (2019) and the Covid-19 pandemic period (2020)
Secondary outcomes

Early definitive treatment rate in 2019 vs. 2020: defined as treatment in accordance with the current guidelines (cholecystectomy or ERCP with endoscopic sphincterotomy during the same hospital admission or within 2 weeks of discharge)
30-day hospital readmission rate in 2019 vs. 2020: defined as hospital readmission within 30- days from discharge for recurrent biliary AP while awaiting interval cholecystectomy, or due to post-cholecystectomy complications
Predictive factors of morbidity and mortality in patients with biliary AP
Join the Study

Would your hospital like to join this study as an actively contributing research centre?