A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy

PURPOSE: Little is presently known on the impact of device type for Doppler-guided hemorrhoidal artery ligation/mucopexy (DGHAL) or circular stapled hemorrhoidopexy (CSH) when a surgical treatment is considered for hemorrhoidal disease (HD). In this study, we aimed to compare the outcome in terms of adverse events and recurrence rate, of patients included in the multicenter LigaLongo RCT ( ClinicalTrials.gov NCT01240772) according to the type of devices used. METHODS: In the DGHAL arm (N = 193), the procedure was done with transanal hemorrhoidal dearterialization (THD)™ (THD, Correggio, Italy) (104 patients) and with HAL-RAR™ (Agency for Medical Innovations (AMI) GmbH, Feldkirch, Austria) (89 patients). In the CSH arm (N = 184), procedure for prolapse and hemorrhoids (PPH)-03™ (Ethicon Endo-Surgery, Cincinnati OH) and hemorrhoidopexy and prolapse (HEM)™ (Covidien, Inc.) staplers were used in respectively 106 and 78 cases. Surgery-related morbidity at 90 postoperative days (POD) based on the Clavien-Dindo procedure-related complication score and clinical outcome in terms of recurrence and reoperation rate at 12 postoperative months (POM) was collected. RESULTS: Three hundred and seventy-seven patients were randomized according to HD grade. In the DGHAL arm, the number of ligations and mucopexies was higher in the AMI group (p < 0.0001); at 90 POD, the overall morbidity was similar between the two groups. In the CSH arm, donut sizes were similar; at 90 POD, the PPH group had a higher risk of postoperative grade 1 morbidity (anal urgency or incontinence) compared to the HEM group (p = 0.003). At 12 POM, no statistical difference was found between the two groups of each arm in terms of grade III recurrence or reoperation. CONCLUSION: Postoperative morbidity and outcome at 1 year were similar regardless of the type of devices used. These findings suggest that device type has little impact on HD treatment results. TRIAL REGISTRATION: clinicaltrials.gov -Identifier NCT01240772

Modèle français d’enseignement de la cœlioscopie aux internes sur modèle porcin (HUGOFirst) : validation de la grille d’évaluation, performance et satisfaction des apprenants au cours d’une série prospective [French Intensive training course in laparoscopic surgery (HUGOFirst) on live porcine models: Validation of a performance assessment scale and residents’ satisfaction in a prospective study]

National audienceIntroduction : La simulation en tant que moyen d’enseignement pratique pour les internes en chirurgie doit être évaluée de façon objective et doit permettre de mettre en valeur l’acquisition de performance de l’étudiant. Les objectifs de cet article sont la publication de nos grilles d’évaluation et leur validation, ainsi que la mesure de satisfaction des étudiants. Méthode Une plateforme d’enseignement pratique sur modèle porcin a été créée en 2009 pour 7 centres hospitaliers universitaires français. Trois fois par an, 31 internes du DESC de chirurgie viscérale effectuaient 5 exercices chronométrés : placement des trocarts (trocarts), test de convergence des instruments (convergence), nœuds intracorporels (nœuds), dérouler l’intestin grêle pour trouver une lésion (déroulé) et réaliser un surjet de fermeture du péritoine (surjet). L’évaluation était réalisée de façon prospective par 2 experts sur des grilles (HuFEG) spécialement conçues et validées pour ces exercices. Le temps, les scores des échelles d’évaluation, l’intérêt et la satisfaction des internes ont été analysés. Résultats : Les données pour 31 internes entre mai 2011 et mars 2012 ont été analysées. Les échelles d’évaluation étaient statistiquement valides et corrélées (K > 0,69) pour chaque exercice. Les temps réalisés par les internes les plus expérimentés étaient significativement plus court dans tous les exercices sauf le déroulé du grêle (p = 0,2). Après 4 sessions, les temps étaient significativement améliorés avec une meilleure qualité (moins de fautes et scores moyens élevés [> 88 %]), indépendamment de l’expérience de l’interne. Parmi les apprenants, 92 % étaient satisfaits, 86 % pensaient que ces sessions amélioraient leurs qualités techniques et 74 % pensaient que cela avait un impact favorable sur leur pratique clinique. Conclusion : Cette étude montre que l’amélioration des techniques chirurgicales par simulation est plébiscitée par les internes et que nos grilles HuFEG sont valides. SummaryIntroduction Simulation as a method for practical teaching of surgical residents requires objective evaluation in order to measure the student's acquisition of knowledge and skills. The objectives of this article are to publish our evaluation and validation grids and also the measure of student satisfaction. Method A teaching platform based on practical exercises with a porcine model was created in 2009 at seven French University Hospitals. Three times a year, 31 diplômes d’études spécialisées complémentaires (DESC) surgical residents underwent timed assessment of the performance of five surgical tasks: trocar insertion (trocars) testing the convergence of instruments (convergence), intra-corporeal knot tying (knots), running of the small intestine to find a lesion (exploration), and performance of a running suture closure of the peritoneum (closure). Two experts evaluated performances prospectively on grid score sheets specifically designed and validated for these exercises. We measured time, scores on a rating scale, and the interest and satisfaction of the residents. Results Data for 31 residents between May 2011 and March 2012 were analyzed. Rating scales were statistically validated and correlated (Kappa correlation coefficient K > 0.69) for each task. The performance times of the most experienced residents decreased significantly for all tasks except for small bowel exploration (P = 0.2). After four sessions, times were significantly improved with better quality (fewer errors and higher average scores [>88%]), regardless of the residents’ experience. Of the participants, 92% were satisfied, 86% thought that the sessions improved their technical skills and 74% thought it had a favorable impact on their clinical practice. Conclusion This study shows that the performance of surgical techniques can be improved through simulation, that HUFEG grids are valid, and that this teaching program is popular with surgical resident

French intensive training course in laparoscopic surgery (HUGOFirst) on live porcine models: Validation of a performance assessment scale and residents’ satisfaction in a prospective study

International audienceIntroduction Simulation as a method for practical teaching of surgical residents requires objective evaluation in order to measure the student's acquisition of knowledge and skills. The objectives of this article are to publish our evaluation and validation grids and also the measure of student satisfaction. Method A teaching platform based on practical exercises with a porcine model was created in 2009 at seven French University Hospitals. Three times a year, 31 Diplôme d’Études Spécialisées Complémentaires (DESC) surgical residents underwent timed assessment of the performance of five surgical tasks: trocar insertion (trocars) testing the convergence of instruments (convergence), intra-corporeal knot tying (knots), running of the small intestine to find a lesion (exploration), and performance of a running suture closure of the peritoneum (closure). Two experts evaluated performances prospectively on grid score sheets specifically designed and validated for these exercises. We measured time, scores on a rating scale, and the interest and satisfaction of the residents. Results Data for 31 residents between May 2011 and March 2012 were analyzed. Rating scales were statistically validated and correlated (Kappa correlation coefficient K > 0.69) for each task. The performance times of the most experienced residents decreased significantly for all tasks except for small bowel exploration (P = 0.2). After four sessions, times were significantly improved with better quality (fewer errors and higher average scores [> 88%]), regardless of the residents’ experience. Of the participants, 92% were satisfied, 86% thought that the sessions improved their technical skills and 74% thought it had a favorable impact on their clinical practice. Conclusion This study shows that the performance of surgical techniques can be improved through simulation, that HUFEG grids are valid, and that this teaching program is popular with surgical resident