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2. Benefit of a flash dose of corticosteroids in digestive surgical oncology: a multicenter, randomized, double blind, placebo-controlled trial (CORTIFRENCH)

Author

Joséphine Magnin, Isabelle Fournel, Alexandre Doussot, Jean-Marc Régimbeau, Philippe Zerbib, Guillaume Piessen, Laura Beyer-Berjot, Sophie Deguelte, Zaher Lakkis, Lilian Schwarz, David Orry, Ahmet Ayav, Fabrice Muscari, François Mauvais, Guillaume Passot, Nelson Trelles, Aurélien Venara, Stéphane Benoist, Mathieu Messager, David Fuks, Baptiste Borraccino, Christophe Trésallet, Alain Valverde, François-Régis Souche, Astrid Herrero, Sébastien Gaujoux, Jérémie Lefevre, Abderrahmane Bourredjem, Amélie Cransac, Pablo Ortega-Deballon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), INSERM-TRANSFERT [Paris] (IT), Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique 1432 (Dijon) - Epidemiologie Clinique/Essais Cliniques (CIC-EC), Université de Bourgogne (UB)-Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Chirurgie digestive [CHU Amiens], CHU Amiens-Picardie, Simplification des soins chez les patients complexes - UR UPJV 7518 (SSPC), Université de Picardie Jules Verne (UPJV), Hôpital Claude Huriez [Lille], CHU Lille, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), MICrobiologie de l'ALImentation au Service de la Santé (MICALIS), AgroParisTech-Université Paris-Saclay-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Laboratoire de Biomécanique Appliquée (LBA UMR T24), Aix Marseille Université (AMU)-Université Gustave Eiffel, Centre Hospitalier Universitaire de Reims (CHU Reims), Department of Hepatology, University Hospital of Besançon, 25000 Besançon, Hospital and University of Rouen, Service de chirurgie [Centre Georges-François Leclerc], Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER-UNICANCER, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Faculté de Médecine [Nancy], Université de Lorraine (UL), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre Hospitalier Simone Veil (CH Simone Veil), Service d'Oncologie Médicale [Centre hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Université de Lyon, Centre Hospitalier René Dubos [Pontoise], University of Angers, Angers Hospital, AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Centre Hospitalier Gustave Dron [Tourcoing], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Paris, Institut Cochin, CNRS, INSERM, F-75014 Paris, France, Centre hospitalier d'Auxerre (CHA), Service de chirurgie digestive, bariatrique et endocrinienne, hôpitaux universitaires Paris Seine-Saint-Denis, hôpital Avicenne, Bobigny, France, Groupe Hospitalier Diaconesses Croix Saint-Simon, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Université de Montpellier (UM), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Saint-Antoine [AP-HP], Paris Center for Microbiome Medicine (FHU PaCeMM), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre d'Investigation Clinique 1432 (Dijon) - Module Plurithématique : Périnatalité Cancérologie Handicap et Ophtalmologie (CIC-P803), Université de Bourgogne (UB)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Chirurgie Digestive, Cancérologique, Générale, Endocrinienne et Urgences (CHU de Dijon), This project is funded by the French Ministry of Health through the Pro‑gramme Hospitalier de Recherche Clinique (PHRC) 2017. The PHRC underwenta full per-review of this study protocol prior to submission. The funding body, Cancer Heterogeneity, Plasticity and Resistance to Therapies - UMR 9020 - U 1277 (CANTHER), Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre National de la Recherche Scientifique (CNRS), Service de Chirurgie viscérale et disgestive, Hôpital Nord [CHU - APHM], Service de Chirurgie Digestive [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Service de chirurgie digestive [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Universitaire de Rangueil, Ciblage thérapeutique en Oncologie (EA3738), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, Service de Chirurgie Digestive et Endocrinienne [CHU Angers], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), CHU Angers, HIFIH, SFR ICAT Université Angers, L'Antique, le Moderne (l'AMO), Université de Nantes - UFR Lettres et Langages (UFRLL), Université de Nantes (UN)-Université de Nantes (UN), Université Paris Cité (UPCité), Service de Chirurgie Digestive, Hépato-Bilio-pancréatique et Transplantation Hépatique [CHU Pitié-Salpétrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de chirurgie générale et digestive [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)

Subjects
Cancer Research, Perioperative corticosteroids, Randomized placebo-controlled trial, Postoperative morbidity, Digestive surgical oncology, Postoperative Complications, Surgical Oncology, Treatment Outcome, Double-Blind Method, Oncology, Adrenal Cortex Hormones, Neoplasms, Genetics, cancer-related outcomes, Humans, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

Background The modulation of perioperative inflammation seems crucial to improve postoperative morbidity and cancer-related outcomes in patients undergoing oncological surgery. Data from the literature suggest that perioperative corticosteroids decrease inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery. Their benefit on cancer-related outcomes has not been assessed. Methods The CORTIFRENCH trial is a phase III multicenter randomized double-blind placebo-controlled trial to assess the impact of a flash dose of preoperative corticosteroids versus placebo on postoperative morbidity and cancer-related outcomes after elective curative-intent surgery for digestive cancer. The primary endpoint is the frequency of patients with postoperative major complications occurring within 30 days after surgery (defined as all complications with Clavien-Dindo grade > 2). The secondary endpoints are the overall survival at 3 years, the disease-free survival at 3 years, the frequency of patients with intraabdominal infections and postoperative infections within 30 days after surgery and the hospital length of stay. We hypothesize a reduced risk of major complications and a better disease-survival at 3 years in the experimental group. Allowing for 5% of drop-out, 1 200 patients (600 per arm) should be included. Discussion This will be the first trial focusing on the impact of perioperative corticosteroids on cancer related outcomes. If significant, it might be a strong improvement on oncological outcomes for patients undergoing surgery for digestive cancers. Trial registration ClinicalTrials.gov, NCT03875690, Registered on March 15, 2019, URL: https://clinicaltrials.gov/ct2/show/NCT03875690.

Published
2022
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3. Implementation of a Surgical Simulation Care Pathway Approach to Training in Emergency Abdominal Surgery

Author

Stéphane Berdah, Laura Beyer-Berjot, Ara Darzi, Rajesh Aggarwal, Vishal Patel, Daniel A. Hashimoto, Pramudith Sirimanna, National Institute of Health Research, and National Institute for Health Research

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, IMPACT, OPERATING-ROOM, 3-D VIRTUAL WORLDS, 030230 surgery, DIAGNOSIS, 03 medical and health sciences, 0302 clinical medicine, medicine, Care pathway, Appendectomy, Humans, Prospective Studies, Simulation Training, OUTCOMES, Science & Technology, business.industry, General surgery, Medical record, EDUCATION, 1103 Clinical Sciences, Perioperative, PERFORMANCE, Vascular surgery, Appendicitis, Cardiac surgery, Cardiothoracic surgery, 030220 oncology & carcinogenesis, SKILLS, TRIAL, Female, Laparoscopy, Surgery, Curriculum, Surgical simulation, Emergency Service, Hospital, business, Life Sciences & Biomedicine, Abdominal surgery
Abstract

Background Simulation-based care pathway approach (CPA) training is a novel approach in surgical education. The objective of the present study was to determine whether CPA was feasible for training surgical residents and could improve efficiency in patients’ management. A common disease was chosen: acute appendicitis. Methods All five junior residents of our department were trained in CPA: preoperative CPA consisted in virtual patients (VPs) presenting with acute right iliac fossa pain; intraoperative CPA involved a virtual competency-based curriculum for laparoscopic appendectomy (LAPP); finally, post-operative VP were reviewed after LAPP. Thirty-eight patients undergoing appendectomy were prospectively included before (n = 21) and after (n = 17) the training. All demographic and perioperative data were prospectively collected from their medical records, and time taken from admission to management was measured. Results All residents had performed less than 10 LAPP as primary operator. Pre- and intraoperative data were comparable between pretraining and post-training patients. Times to liquid and solid diet were significantly reduced after training [7 h (2–20) vs. 4 (4–6); P = 0.004, and 17 h (4–48) vs. 6 (4–24); P = 0.005] without changing post-operative morbidity [4 (19%) vs. 0 (0); P = 0.11] and length of stay [48 h (30–264) vs. 44 (21–145); P = 0.22]. Conclusions CPA training is feasible in abdominal surgery. In the current study, it improved patients’ management in terms of earlier oral intake.

Published
2019
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4. Learning Curve in Laparoscopic Liver Resection, Educational Value of Simulation and Training Programmes: A Systematic Review

Author

Stéphane Berdah, David Jérémie Birnbaum, Olivier Farges, Théophile Guilbaud, and Laura Beyer Berjot

Subjects
medicine.medical_specialty, medicine.diagnostic_test, business.industry, General surgery, MEDLINE, Significant learning, Evidence-based medicine, 030230 surgery, Vascular surgery, Resection, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Or education, Hepatectomy, Humans, Medicine, Laparoscopy, Surgery, business, Simulation Training, Learning Curve, Abdominal surgery
Abstract

The laparoscopic approach is widely accepted as the procedure of choice for abdominal surgery. However, laparoscopic liver resection (LLR) has advanced slowly due to the significant learning curve (LC), and only few publications have dealt with advanced training in LLR. Two reviewers conducted systematic research through MEDLINE and EMBASE with combinations of the following keywords: (learning curve OR teaching OR training OR simulation OR education) AND (liver OR hepatic) AND (laparoscopic OR laparoscopy). Robotic-assisted, hand-assisted and hybrid LLRs were excluded. Nineteen studies were retrieved. Overall, the level of evidence was low. Thirteen articles assessed the LC during real-life LLR, and six articles focussed on simulation and training programmes in LLR. The LC in minor LLR comprised 60 cases overall, and 15 cases for standardised left lateral sectionectomy. For major LLR (MLLR), the LC was 50 cases for most studies, but was reported to be 15–20 cases in more recent studies, provided MLLR is performed progressively in selected patients. However, there was heterogeneity in the literature regarding the number of minor LLRs required before MLLR, with 60 minor LLRs reported as the minimum. Six studies showed a potential benefit of simulation and training programmes in this field. The gradual implementation of LLR combined with simulation-based training programmes could reduce the clinical impact of LC. The LC in LLR is a long process, and MLLR should be gradually implemented under the supervision of experienced surgeons. Training outside the operating room may reduce the LC in real-life situations.

Published
2019
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5. Value of early repeated abdominal CT in selective non-operative management for blunt bowel and mesenteric injury

Author

Marc Leone, Ugo Scemama, A Maignan, Kathia Chaumoitre, Laurent Boyer, S. Berdah, Thierry Bege, Laura Beyer-Berjot, F Lannes, Assistance Publique - Hôpitaux de Marseille (APHM), Aix Marseille Université (AMU), Laboratoire de cristallographie et sciences des matériaux (CRISMAT), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-École Nationale Supérieure d'Ingénieurs de Caen (ENSICAEN), Normandie Université (NU)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche sur les Matériaux Avancés (IRMA), Normandie Université (NU)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Centre National de la Recherche Scientifique (CNRS)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université de Rouen Normandie (UNIROUEN), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Centre National de la Recherche Scientifique (CNRS), Laboratoire de Biomécanique Appliquée (LBA UMR T24), Aix Marseille Université (AMU)-Université Gustave Eiffel, Hôpital Nord [CHU - APHM], Microbes évolution phylogénie et infections (MEPHI), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), École Nationale Supérieure d'Ingénieurs de Caen (ENSICAEN), Normandie Université (NU)-Normandie Université (NU)-Centre National de la Recherche Scientifique (CNRS)-Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Institut de Chimie du CNRS (INC), Department of Digestive Surgery. Hôpital Nord, Centre de résonance magnétique biologique et médicale (CRMBM), Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Assistance Publique-Hôpitaux de Marseille (AP-HM), Anthropologie bio-culturelle, Droit, Ethique et Santé (ADES), and Aix Marseille Université (AMU)-EFS ALPES MEDITERRANEE-Centre National de la Recherche Scientifique (CNRS)

Subjects
Male, medicine.medical_treatment, Abdominal Injuries, Wounds, Nonpenetrating, 030218 nuclear medicine & medical imaging, law.invention, Injury Severity Score, 0302 clinical medicine, Randomized controlled trial, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, law, Laparotomy, Medicine, Mesentery, Child, Tomography, ComputingMilieux_MISCELLANEOUS, Neuroradiology, Aged, 80 and over, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, medicine.diagnostic_test, Ultrasound, Interventional radiology, General Medicine, Middle Aged, 3. Good health, Intestines, Research Design, 030220 oncology & carcinogenesis, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, Female, Radiology, Adult, medicine.medical_specialty, Adolescent, X-ray computed, [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery, Young Adult, 03 medical and health sciences, Blunt, McNemar's test, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [INFO.INFO-IM]Computer Science [cs]/Medical Imaging, Humans, [SDV.MP.PAR]Life Sciences [q-bio]/Microbiology and Parasitology/Parasitology, Radiology, Nuclear Medicine and imaging, Aged, Retrospective Studies, business.industry, Patient Selection, Wounds and injuries, Retrospective cohort study, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, Tomography, X-Ray Computed, business, Conservative treatment
Abstract

To evaluate the performance of an early repeated computed tomography (rCT) in initially non-operated patients with blunt bowel and mesenteric injuries (BBMI). This was a monocentric retrospective observational study from 2009 to 2017 of patients with a BBMI on initial CT (iCT). Patients initially non-operated on were scheduled for a rCT within 48 h. Initial CT and rCT diagnostic performance were compared based on a surgical injury prediction score previously described. For statistical analysis, we used the chi-square analyses for paired data (McNemar test). Eighty-four patients (1.9% of trauma) had suspected BBMI on iCT. Among these patients, 22 (26.2%) were initially operated on, 18 (21.4%) were later operated on, and 44 (52.4%) were not operated on. The therapeutic laparotomy rate was 85%. Thirty-four patients initially non-operated on had a rCT. The absolute value of the CT scan score increased for 15 patients (44.1%). The early rCT diagnostic performance, compared with iCT, showed an increase in sensitivity (from 63.6 to 91.7%), in negative predictive value (from 77.4 to 94.7%), and in AUC (from 0.77 to 0.94). In initially non-operated patients with BBMI lesions, the performance of an early rCT improved the sensitivity of lesion detection requiring surgical repair and the security of patient selection for non-operative treatment. • Selective non-operative treatment for hemodynamically stable patients with blunt bowel and/or mesenteric injuries on CT is developing but remains controversial. • An early repeated CT improved the sensitivity of lesion detection requiring surgical repair and the security of patient selection for conservative treatment.

Published
2019
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6. Deliberate practice enhances quality of laparoscopic surgical performance in a randomized controlled trial: from arrested development to expert performance

Author

Daniel A. Hashimoto, Noel N. Williams, Rajesh Aggarwal, Ernest D. Gomez, Laura Beyer-Berjot, Ara Darzi, Pramudith Sirimanna, K. A. Ericsson, National Institute for Health Research, Saint Mary's Hospital [London], St Mary's Hospital [London], Hospital of the University of Pennsylvania (HUP), Perelman School of Medicine, University of Pennsylvania [Philadelphia]-University of Pennsylvania [Philadelphia], Laboratoire de Biomécanique Appliquée (LBA UMR T24), Aix Marseille Université (AMU)-Université Gustave Eiffel, Florida State University [Tallahassee] (FSU), Department of Medecine [Montréal], McGill University = Université McGill [Montréal, Canada], and University of Pennsylvania-University of Pennsylvania

Subjects
Male, medicine.medical_specialty, Swine, media_common.quotation_subject, medicine.medical_treatment, Virtual reality, Article, Education, law.invention, User-Computer Interface, Randomized controlled trial, law, Task Performance and Analysis, Animals, Humans, Medicine, Cholecystectomy, Quality (business), media_common, Science & Technology, REALITY TRAINING CURRICULUM, integumentary system, ACQUISITION, business.industry, Internship and Residency, COLORADO, 1103 Clinical Sciences, Surgical training, LAPAROSCOPIC, 3. Good health, Acs nsqip, Cholecystectomy, Laparoscopic, SIMULATION, UTAH, Physical therapy, Surgery, Clinical Competence, Curriculum, ADVERSE EVENTS, Clinical competence, TECHNICAL SKILLS, business, Life Sciences & Biomedicine, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Imaging & VR, Abdominal surgery
Abstract

Background This study investigated whether deliberate practice leads to an increase in surgical quality in virtual reality (VR) laparoscopic cholecystectomies (LC). Previous research has suggested that sustained DP is effective in surgical training. Methods Fourteen residents were randomized into deliberate practice (n = 7) or control training (n = 7). Both groups performed ten sessions of two VR LCs. Each session, the DP group was assigned 30 min of DP activities in between LCs while the control group viewed educational videos or read journal articles. Performance was assessed on speed and dexterity; quality was rated with global (GRS) and procedure-specific (PSRS) rating scales. All participants then performed five porcine LCs. Results Both groups improved over 20 VR LCs in time, dexterity, and global rating scales (all p < 0.05). After 20 LCs, there were no differences in speed or dexterity between groups. The DP group achieved higher quality of VR surgical performance than control for GRS (26 vs. 20, p = 0.001) and PSRS (18 vs. 15, p = 0.001). For VR cases, DP subjects plateaued at GRS = 25 after ten cases and control group at GRS = 20 after five cases. At completion of VR training, 100 % of the DP group reached target quality of performance (GRS ≥ 21) compared with 30 % in the control group. There were no significant differences for improvements in time or dexterity over five porcine LCs. Conclusion This study suggests that DP leads to higher quality performance in VR LC than standard training alone. Standard training may leave individuals in a state of “arrested development” compared with DP.

Published
2014
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