Ville Sallinen, Salomone Di Saverio, Eija Haukijärvi, Risto Juusela, Heidi Wikström, Vesa Koivukangas, Fausto Catena, Berndt Enholm, Arianna Birindelli, Ari Leppäniemi, Panu Mentula, Laparoscopic versus open adhesiolysis for adhesive small bowel obstruction (LASSO): an international, multicentre, randomised, open-label trial, The Lancet Gastroenterology & Hepatology, Volume 4, Issue 4, 2019, Pages 278-286, ISSN 2468-1253, https://doi.org/10.1016/S2468-1253(19)30016-0.
Laparoscopic versus open adhesiolysis for adhesive small bowel obstruction (LASSO) : an international, multicentre, randomised, open-label trial
|Author:||Sallinen, Ville1,2; Di Saverio, Salomone3,4; Haukijärvi, Eija5;|
1Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Finland
2Department of Transplantation and Liver Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
3Maggiore Hospital Bologna, Bologna, Italy
4Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge Biomedical Campus, Hills Road, Cambridge, UK
5Tampere University Hospital, Tampere, Finland
6Vaasa Central Hospital, Vaasa, Finland
7Peijas Hospital, Vantaa, Finland
8Department of Surgery, Oulu University Hospital, Oulu, Finland
9Emergency Surgery Department, Parma University Hospital, Parma, Italy
10Department of Surgery, Päijät-Häme Central Hospital, Lahti, Finland
11Department of Surgery, University of Bologna, Bologna, Italy
|Online Access:||PDF Full Text (PDF, 11.4 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe2020102085746
|Publish Date:|| 2020-10-20
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.
The Lancet. Gastroenterology & hepatology
|Pages:||278 - 286|
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3126 Surgery, anesthesiology, intensive care, radiology
The trial was funded by Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth’s Foundation, Martti I. Turunen Foundation, and Governmental competitive research funds (EVO / VTR / TYH). No commercial entities provided supportor wereinvolved in the trial.
© 2019. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http:/creativecommons.org/licenses/by-nc-nd/4.0/