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Procedural Surgical RCTs in Daily Practice

Do Surgeons Adopt Or Is It Just a Waste of Time?

Oberkofler, Christian E. MD*; Hamming, Jacob F. MD, PhD; Staiger, Roxane D. MD*; Brosi, Philippe MD*; Biondo, Sebastiano MD, PhD; Farges, Olivier MD, PhD§; Legemate, Dink A. MD, PhD; Morino, Mario MD||; Pinna, Antonio D. MD**; Pinto-Marques, Hugo MD, PhD††; Reynolds, John V. MD‡‡; Campos, Ricardo Robles MD, PhD§§; Rogiers, Xavier MD¶¶; Soreide, Kjetil MD, PhD||||; Puhan, Milo A. MD, PhD***; Clavien, Pierre-Alain MD, PhD*; Rinkes, Inne Borel MD, PhD†††

doi: 10.1097/SLA.0000000000003546
SPECIAL ESA LECTURE 2019
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Objective: To assess the adoption of recommendation from randomized clinical trials (RCTs) and investigate factors favoring or preventing adoption.

Background: RCT are considered to be the cornerstone of evidence-based medicine by representing the highest level of evidence. As such, we expect RCT's recommendations to be followed rigorously in daily surgical practice.

Methods: We performed a structured search for RCTs published in the medical and surgical literature from 2009 to 2013, allowing a minimum of 5-year follow-up to convincingly test implementation. We focused on comparative technical or procedural RCTs trials addressing the domains of general, colorectal, hepatobiliary, upper gastrointestinal and vascular surgery. In a second step we composed a survey of 29 questions among ESA members as well as collaborators from their institutions to investigate the adoption of surgical RCTs recommendation.

Results: The survey based on 36 RCTs (median 5-yr citation index 85 (24–474), from 21 different countries, published in 15 high-ranked journals with a median impact factor of 3.3 (1.23–7.9) at the time of publication. Overall, less than half of the respondents (47%) appeared to adhere to the recommendations of a specific RCT within their field of expertise, even when included in formal guidelines. Adoption of a new surgical practice was favored by watching videos (46%) as well as assisting live operations (18%), while skepticism regarding the methodology of a surgical RCT (40%) appears to be the major reason to resist adoption.

Conclusion: In conclusion, surgical RCTs appear to have moderate impact on daily surgical practice. While RCTs are still accepted to provide the highest level of evidence, alternative methods of evaluating surgical innovations should also be explored.

*Department of Surgery and Transplantation, University Hospital Zurich, Zurich, Switzerland,

Department of Vascular Surgery, Leiden University Medical Center, Leiden, The Netherlands

Department of General and Digestive Surgery, Bellvitge University Hospital, Barcelona, Spain

§Department of Surgery and Transplantation, Hôpital Beaujon, Clichy, France

Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands

||Department of Digestive Surgery, Hospital San Giovanni Battista, University of Torino, Torino, Italy

**Digestive Disease Institute, Cleveland Clinic, Abu Dhabi, United Arab Emirates

††Department of Surgery, Curry Cabral Hospital, Lisbon, Portugal

‡‡Department of General Surgery, St. James's Hospital, Dublin, Ireland

§§Department of Surgery and Transplantation, Virgen de la Arrixaca Clinic and University Hospital, Murcia, Spain

¶¶Department of Surgery and Transplantation, Gent University Hospital and Medical School UZG, Gent, Belgium

||||Department of Clinical Medicine, Gastrointestinal Surgery, HPB unit, Stavanger, Norway

***Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland

†††Department Surgical Oncology, Endocrine and GI Surgery, University Hospital Utrecht, Utrecht, The Netherlands.

I.H.M.BorelRinkes@umcutrecht.nl.

The authors report no conflicts of interest.

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