Laparoscopic versus open adhesiolysis for adhesive small bowel obstruction (LASSO) : an international, multicentre, randomised, open-label trial

Background Although laparoscopic adhesiolysis for adhesive small bowel obstruction is being done more frequently, it is not widely accepted due to the lack of supporting evidence of its superiority over an open approach and concerns regarding its benefits. We aimed to investigate whether laparoscopic adhesiolysis was a superior treatment for adhesive small bowel obstruction compared with an open approach in terms of length of postoperative hospital stay and morbidity. Methods In this international, multicentre, parallel, open-label trial, we randomly assigned patients (1: 1) aged 18-95 years who had adhesive small bowel obstruction that had not resolved with conservative management to have either open or laparoscopic adhesiolysis. The study was done in five academic university hospitals and three community (central) hospitals in two countries (Finland [n=3 academic university hospitals; n=3 community hospitals] and Italy [n=2 academic university hospitals]). We included only patients with high likelihood of a single adhesive band in the trial; additionally, patients who had an anaesthesiological contraindication, were pregnant, living in institutionalised care, or who had a hospital stay of more than 1 week before the surgical consultation were excluded from the trial. The randomisation sequence was generated using block randomisation, with randomly varied block sizes and stratified according to centre. The primary outcome was postoperative length of hospital stay assessed at time of discharge in the modified intention-to-treat population. Findings Between July 18, 2013, and April 9, 2018, 566 patients were assessed for eligibility, of whom 104 patients were randomly assigned to the open surgery group (n=51) or to the laparoscopy group (n=53). Of these patients, 100 were included in the modified intention-to-treat analyses (49 in the open surgery group; 51 in the laparoscopy group). The postoperative length of hospital stay for open surgery group was on average 1.3 days longer than that in the laparoscopy group (geometric mean 5.5 days [range 2-19] vs 4.2 days [range 1 -20]; ratio of geometric means 1.31 [95% CI 1.06-1.61]; p=0.013). 21 (43%) patients in the open surgery group and 16 (31%) patients in the laparoscopy group had postoperative complications (Clavien-Dindo any grade) within 30 days (odds ratio 0.61 [95% CI 0.27-1.38]; p=0.23). One patient died in each group within 30 days. Interpretation Laparoscopic adhesiolysis provides quicker recovery in selected patients with adhesive small bowel obstruction than open adhesiolysis. Copyright (C) 2019 Elsevier Ltd. All rights reserved.Peer reviewe

euCanSHare. Deliverable D4.1 - Opal software integration to euCanSHare

euCanSHare deliverable D4.1 reporting on the opal software integration to euCanSHare Executive Summary: In order to support the data harmonization process to be achieved within euCanSHare as well as proper documentation of the harmonized datasets generated, it is essential to implement a data and metadata documentation, processing and management system. The OBiBa software suite (Opal, Mica and Agate) and harmonization and cataloguing resources (harmonization guidelines and metadata standards) developed by Maelstrom Research are used as key elements of the EuCanSHare system. OBiBa software infrastructures are implemented in Spain, Finland, Germany and Canada to form the EuCanSHare harmonization platform. The platform will be pilot tested in 2019-2020 and, where required, the software will be customized to serve the evolving needs of EuCanSHare. The deliverable is a software and this report is the written description and presentation of the software and its implementation in different environments to support EuCanSHare activities.</p