Santos A, Mentula P, Pinta T, et al. Quality-of-Life and Recurrence Outcomes Following Laparoscopic Elective Sigmoid Resection vs Conservative Treatment Following Diverticulitis: Prespecified 2-Year Analysis of the LASER Randomized Clinical Trial. JAMA Surg. 2023;158(6):593–601. doi:10.1001/jamasurg.2023.0466
Quality-of-life and recurrence outcomes following laparoscopic elective sigmoid resection vs conservative treatment following diverticulitis : prespecified 2-year analysis of the LASER randomized clinical trial
|Author:||Santos, Alexandre1; Mentula, Panu1; Pinta, Tarja2;|
1Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
2Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland
3Department of Surgery, Medical Research Center, Oulu University Hospital, Oulu, Finland
4Department of Surgery, Vaasa Central Hospital, Vaasa, Finland
5Department of Surgery, Hyvinkää Hospital, Hyvinkää, Finland
6Transplantation and Liver Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
|Online Access:||PDF Full Text (PDF, 0.4 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe20231004138737
American Medical Association,
|Publish Date:|| 2023-10-04
Importance: Both elective sigmoid resection and conservative treatment are options for patients with recurrent, complicated, or persistent painful diverticulitis; understanding outcomes following each can help inform decision-making.
Objective: To compare outcomes of elective sigmoid resection and conservative treatment for patients with recurrent, complicated, or persistent painful diverticulitis at 2-year follow-up.
Design, Setting, and Participants: This multicenter parallel open-label individually randomized clinical trial comparing elective sigmoid resection to conservative treatment in patients with recurrent, complicated, or persistent painful diverticulitis was carried out in 5 Finnish hospitals between September 2014 and October 2018. Follow-up up to 2 years is reported. Of 85 patients randomized and included, 75 and 70 were available for QOL outcomes at 1 year and 2 years, respectively, and 79 and 78 were available for the recurrence outcome at 1 year and 2 years, respectively. The present analysis was conducted from September 2015 to June 2022.
Interventions: Laparoscopic elective sigmoid resection vs conservative treatment (patient education and fiber supplementation).
Main Outcomes and Measures: Prespecified secondary outcomes included Gastrointestinal Quality of Life Index (GIQLI) score, complications, and recurrences within 2 years.
Results: Ninety patients (28 male [31%]; mean [SD] age, 54.11 [11.9] years and 62 female [69%]; mean [SD] age, 57.13 [7.6] years) were randomized either to elective sigmoid resection or conservative treatment. After exclusions, 41 patients in the surgery group and 44 in the conservative group were included in the intention-to-treat analyses. Eight patients (18%) in the conservative treatment group underwent sigmoid resection within 2 years. The mean GIQLI score at 1 year was 9.51 points higher in the surgery group compared to the conservative group (mean [SD], 118.54 [17.95] vs 109.03 [19.32]; 95% CI, 0.83-18.18; P = .03), while the mean GIQLI score at 2 years was similar between the groups. Within 2 years, 25 of 41 patients in the conservative group (61%) had recurrent diverticulitis compared to 4 of 37 patients in the surgery group (11%). Four of 41 patients in the surgery group (10%) and 2 of 44 in the conservative group (5%) had major postoperative complications within 2 years. In per-protocol analyses, the mean (SD) GIQLI score was higher in the surgery group compared to the conservative treatment group by 11.27 points at 12 months (119.42 [17.98] vs 108.15 [19.28]; 95% CI, 2.24-20.29; P = .02) and 10.43 points at 24 months (117.24 [15.51] vs 106.82 [18.94]; 95% CI, 1.52-19.33; P = .02).
Conclusions and Relevance: In this randomized clinical trial, elective sigmoid resection was effective in preventing recurrent diverticulitis and improved quality of life over conservative treatment within 2 years.
Trial Registration: ClinicalTrials.gov Identifier: NCT02174926
|Pages:||593 - 601|
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3126 Surgery, anesthesiology, intensive care, radiology
The study was funded by Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth’s Foundation, Martti I. Turunen Foundation, the Finnish Medical Foundation, and Helsinki University Hospital research funds.
© 2023 Santos A et al. JAMA Surgery. This is an open access article distributed under the terms of the CC-BY License.