Ville Sallinen1, Salomone Di Saverio2, Eija Haukijärvi3, Risto Juusela4, Heidi Wikström5, Vesa Koivukangas6, Fausto Catena7, Berndt Enholm8, Arianna Birindelli9, Ari Leppäniemi10, Panu Mentula10. 1. Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Department of Transplantation and Liver Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. Electronic address: ville.sallinen@helsinki.fi. 2. Maggiore Hospital Bologna, Bologna, Italy; Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge Biomedical Campus, Cambridge, UK. 3. Tampere University Hospital, Tampere, Finland. 4. Vaasa Central Hospital, Vaasa, Finland. 5. Peijas Hospital, Vantaa, Finland. 6. Department of Surgery, Oulu University Hospital, Oulu, Finland. 7. Emergency Surgery Department, Parma University Hospital, Parma, Italy. 8. Department of Surgery, Päijät-Häme Central Hospital, Lahti, Finland. 9. Department of Surgery, University of Bologna, Bologna, Italy. 10. Department of Abdominal Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Abstract
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. FUNDING: Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth's Foundation, Martti I Turunen Foundation, and governmental (Finland) competitive research funds (EVO/VTR/TYH).
RCT Entities:
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 patientdied in each group within 30 days. INTERPRETATION: Laparoscopic adhesiolysis provides quicker recovery in selected patients with adhesive small bowel obstruction than open adhesiolysis. FUNDING: Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth's Foundation, Martti I Turunen Foundation, and governmental (Finland) competitive research funds (EVO/VTR/TYH).
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