ENCORE protocol v1.1 20AUG2021 Final
ENCORE Study
Dear investigator,
The call for centres for the ENCORE Study is now closed.
The ENCORE Study: An explanation by the Chief Investigator Prof. Max Bell
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)
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Timeline
- Call for centre: Closed
- Start of patient recruitment: 1 December 2021
- Last patient : 31 December 2023
Study Objectives
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).
Steering Committee
- 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 (CI)
- Anil Gupta, Associate Professor, Karolinska University Hospital, Solna, Sweden
- Christian Buchli, MD, PhD, Karolinska University Hospital, Solna, Sweden; K1 Department of Molecular Medicine and Surgery
- Daniel Brattström, MD, PhD, Senior Consultant, Stockholm County Council, Oncologist
- Mats Enlund, Associate Professor, Department of Anaesthesia, Västerås Hospital, affiliated with Uppsala University Hospital
- Shaman Jhanji, MD, anaesthetist and intensivist at the Royal Marsden Hospital in London, UK
- Bernhard Riedel, Professor, Director of Anaesthesia at Peter MacCallum Cancer Centre, Sydney, Australia
- Antje Gottschalk, MD, PhD, Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany
- Donal Buggy, Professor of Anaesthesiology & Perioperative Medicine, Mater University Hospital, School of Medicine, University College Dublin, Ireland; Consultant in Anaesthesiology & Perioperative Medicine, Mater University Hospital & Mater Private Hospital, Dublin, Ireland
- Helene Beloeil, Professor of Professor of Anesthesiology Critical Care Medicine and Perioperative Medicine, Rennes University Hospital and School of Medicine, CHU de Rennes, France
- Fredrik Granath, Associate Professor, Senior Lecturer, Biostatistician, Karolinska University Hospital, Solna, Sweden; K2 Department of Medicine, Solna
- Hans de Boer, Anesthesiologist and Pain Specialist, Department of Anesthesiology Pain Medicine and Procedural Sedation and Analgesia, Martini General Hospital Groningen, The Netherlands (As a representative member of the ESAIC Research Committee)
Participating countries
Sponsor
The study is entirely sponsored by a grant from the European Society of Anaesthesiology and Intensive Care Clinical Trial Network (ESAIC CTN). The ESAIC CTN provides an infrastructure for clinical research in the fields of Anaesthesia, Pain, Intensive Care and Emergency Medicine by transnational European collaborative studies.
National Coordinator list
Country | Title | National PI | Institution and City |
Argentina | Dr. | Diana Alejandra Pantoja Pachajoa. | Clinica Universitaria Reina Fabiola, Cordoba |
Australia | Dr. | Julia Dubowitz | Peter MacCallum Cancer Centre |
Austria | Dr. | Peter Paal | St. John of God hospital, Paracelsus Medical University, Salzburg, Austria |
Canada | Dr. | Stuart McCluskey | Toronto General Hospital |
Denmark | Dr. | Rune Petring Hasselager | Center for Surgical Science, Zealand University Hospital, Denmark |
Egypt | Dr. | Moataz M. Emara | Mansoura University Hospital, Egypt. |
Finland | Dr. | Hanna Vihervaara | Turun yliopistollinen keskussairaala, Turku |
France | Prof. Dr. | Helene Beloeil Lucillia Bezu | CHU Rennes Gustave Roussy Cancer Center |
Germany | Prof. | Maria Wittmann | University Hospital Bonn |
Greece | Dr. | Eleni Koraki | GENERAL HOSPITAL OF THESSALONIKI G. PAPANIKOLAOU |
India | Dr. | Jyotsna Goswami | Tata Medical Center Kolkata |
Italy | Prof. | Savino Spadaro | University of Ferrara |
Jordan | Dr. | Lou’i Al-Husinat | Yarmouk University, Irbid |
Libya | Dr. | Muhammed Elhadi | Faculty Medicine University of Tripoli |
Malaysia | Dr. | Ina Ismiarti Shariffuddin | University Malaya, Kuala Lumpur |
Morocco | Dr. | Abdelilah Ghannam | National Institute of Oncology of Rabat |
Netherlands | Prof. | Markus Hollmann | Amsterdam UMC |
New Zealand | Dr. | Matthew Hart | Auckland Hospital |
North Macedonia | Dr. | Filip Naumovski | University Clinical Center “Mother Theresa”, Skopje |
Norway | Dr. | Ib Jammer | Haukeland University Hospital |
Poland | Dr. | Kotfis | Katarzyna |
Portugal | Dr. | Ana Almeida | University Hospital Center in Coimbra |
Romania | Dr. | Liliana Mirea | Clinical EmergencyHospital of Bucharest |
Russia | Prof. | Igor Zabolotskikh | Kuban State Medical University, Krasnodar, Russia. |
Saudi Arabia | Dr. | abdullah abolkhair | King Faisal Specialist Hospital and research Center Riyadh |
Serbia | Prof. | Maja Stojanovic | Zvezdara University Medical Center |
Spain | Dr. Dr. | Oscar Diaz Cambronero Irene Leon Carsi | Hospital Universitari la Fe, Valencia |
Sudan | Dr. | Hytham K. S. Hamid | East Nile (Sharg Alneel) Hospital |
Sweden | Dr. | Anil Gupta | Karolinska University Hospital, Stockholm |
Syria | Dr. | Alaa Hamdan | Tishreen University Hospital |
Turkey | Prof. | Kemal Tolga Saracoglu | Hospital Istanbul |
Ukraine | Dr. | Yelyzaveta Plechysta | medical network «DOBROBUT» Kiev |
United Arab Emirates | Prof. | Massimo Lamperti | Cleveland Clinic Abu Dhabi |
USA | Dr. | Luis Tollinche | Metrohealth Medical Center |
Protocol, Appendices and other Study Documents
ENCORE Appendix 1 – Study Synopsis v1.0 21DEC20
ENCORE Appendix 3 – Pre-Study Questionnaire for participation in the ENCORE trial v1.0 21DEC20
ENCORE Appendix 4 – Approval Documentation Coversheet v1.0 21DEC20
ENCORE Appendix 5 – Case Report Form v2.0 16JUNE22 FINAL & Coversheet
ENCORE Appendix 6 – Confidential Patient Logsheet v1.0 21DEC20
ENCORE Appendix 7 – End of study Reporting Form v1.0 21DEC20
ENCORE Appendix 8 – Staging of colorectal cancer v1.0 21DEC20
ENCORE Appendix 9 – Definitions v1.0 21DEC20
ENCORE Appendix 10 – Clavien Dindo Classification v1.0 21DEC20
ENCORE Appendix 11 – ASA-Physical status Classification v1.0 21DEC20
ENCORE Appendix 12 – M-DASI 4 q v1.0 21DEC20
ENCORE Appendix 13 – Postoperative complications v1.0 21DEC20
ENCORE Appendix 14 – Authorship policy v1.0 21DEC20
IV Morphine equivalents for commonly used drugs
ENCORE eCRF FAQ 20MAR23
ENCORE eCRF Completion Manual v1.2 17JAN22
ENCORE FAQ 25MAY23
Opioid Dose Equivalence Calculation Table
Validated Patients Documents and Translation
DENMARK
ENCORE Appendix 2C – Patient information sheet and consent – Consent v1.0 21DEC20 – Danish for Denmark – Validated 18OCT21
EGYPT
ENCORE Appendix 2B – Patient information sheet and consent – Leg interest v1.0 21DEC20 – Arabic for Egypt- Validated 16MAR21
FINLAND
ENCORE Appendix 2B – Patient information sheet and consent – Legitimate interest v1.0 21DEC20 – Finnish for Finland – Validated 16SEP21
ENCORE Appendix 2B – Patient information sheet and consent – Legitimate interest v1.0 21DEC20 – Swedish for Finland – Validated 18OCT21
FRANCE
ENCORE Appendix 1 – Translation to French of Study Synopsis v1.0 21DEC20 Validated 10FEB21
ENCORE Appendix 2A – Patient information sheet V1.0 21Dec20 – French for France – Validated 10FEB21
GERMANY
ENCORE Appendix 2C – Patient information sheet and consent – Consent v1.0 – Translated into German for Germany – Validated 10JUN21
GREECE
ENCORE Appendix 2C – Patient information sheet and consent – Consent v1.0 21DEC20 – Greek for Greece – Validated 31MAR21
INDIA
Bengali ENCORE Appendix 2B – PIS and ICF – Legitimate interest v1.0 21DEC20 – Bengali for India – Validated 02MAR21
Hindi ENCORE Appendix 2B – PIS and ICF
Hindi Legitimate interest v1.0 21DEC20 – Hindi for India – validated 02MAR2021
Malayalam ENCORE Appendix 2B – PIS and ICF Legitimate interest v1.0 21DEC20 – Malayalam for India – Validated 30SEP21
Odia ENCORE Appendix 2B – Patient information sheet and consent – Legitimate interest v1.0 21DEC20 – Odia for India – Validated 06JAN2022
Gujarati ENCORE Appendix 2B – Patient information sheet and consent – Legitimate interest v1.0 21DEC20 – Gujarati – Validated 09FEB22
Kannada ENCORE Appendix 2B – PIS and ICF – Legitimate interest v1.0 21DEC20 – Kannada for India – Validated 15SEP2022
Telugu ENCORE Appendix 2B – PIS and ICF – Legitimate interest v1.0 21DEC20 – Telugu for India – Validated 15SEP2022
IRAQ
ENCORE Appendix 2B – Patient information sheet and consent – Legitimate interest v1.0 21DEC20
ITALY
ENCORE protocol v1.0 – Italian Translation – Validated 16MAR21
ENCORE Appendix 2C-Patient information Sheet and consent-consent v1.0 21Dec20 – Italian for Italy -validated 16MAR21
JORDAN
ENCORE Appendix 2B – Patient information sheet and consent – Legitimate interest v1.0 21DEC20 – Arabic Jordan-Validated 02JAN23
LIBYA
ENCORE Appendix 2B – Patient information sheet and consent – Legitimate interest v1.0 21DEC20 – Arabic for Libya – Validated 29MAR21
MALAYSIA
ENCORE Appendix 2B – Patient information sheet and consent – Legitimate interest v1.0 21DEC20 – Malaysian for Malaysia – Validated 28SEP21
MOROCCO
ENCORE Appendix 2C – Patient Information sheet and IC – Consent v1.0 21Dec20 – Arabic for Morocco – Validated 31MAR21
POLAND
ENCORE Appendix 2A – Patient information sheet – legitimate interest v1.0 21DEC20_Poland_Validated12JUNE23
ENCORE Appendix 2B – Patient information sheet and consent – Legitimate interest v1.0 21DEC20_Poland_Validated12JUNE23
ENCORE Appendix 2C – Patient information sheet and consent – Consent v1.0 21DEC20_Poland_Validated 12JUNE23
PORTUGAL
ENCORE Appendix 2C – Patient information sheet and consent – Consent v1.0 21DEC20 – Portuguese for Portugal – Validated 26APR21
ROMANIA
ENCORE Appendix 2B Patient information sheet and IC for Romania – Validated 03APR23
RUSSIA
ENCORE -Appendix 2A – Patient Information sheet v1.0 21Dec20 – in Russian for Russia – Validated 09JUN21
ENCORE -Appendix 2B – PIS and IC – Legitimate interest v1.0 21Dec20 – Russian for Russia – Validated 09JUN21
ENCORE protocol v1.0 – Translated into Russian for Russia – Validated 09JUN21
SAUDI ARABIA
ENCORE Appendix 2A -Patient information sheet – Legitimate interest v1.0 21DEC20 – Arabic for Saudi Arabia Validated 15JUL21
SERBIA
ENCORE Appendix 2C – Patient information sheet and consent – Consent v1.0 21DEC20 – Serbian for Serbia – Validated 11NOV21
SLOVENIAN
ENCORE Appendix 2B – Patient information sheet and consent – Legitimate interest v1.0 21DEC20 Slovenian – Validated 20SEP21
SPAIN
ENCORE Apéndice 1 – Resumen del Protocolo v1.0 docx. Validated02MAR2021
ENCORE Appendix 2C – PIS and ICF – Consent v1.0 21Dec20 – Spanish fo Spain – Validated 02MAR2021
SUDAN
ENCORE Appendix 2B – Patient information sheet and consent – Arabic for Sudan-Validated 26MAY21
TURKEY
ENCORE Appendix 2C – Patient information sheet and consent – Consent – Turkish Translation – Validated 18MAR2021
UKRAINE
ENCORE Appendix 2C – Patient information sheet and consent – Consent v1.0 21DEC20 – Ukrainian Validated 18AUG21
Endorsements
SIAARTI: Italian Society of Anaesthesiology, Analgesia, Reanimation and Intensive Care
Italy
Support
ENCORE Study is proud to announce its support by :
Do you want to endorse or support our study too? Please contact us at encore@esaic.org