Santos A, Mentula P, Pinta T, et al. Comparing Laparoscopic Elective Sigmoid Resection With Conservative Treatment in Improving Quality of Life of Patients With Diverticulitis: The Laparoscopic Elective Sigmoid Resection Following Diverticulitis (LASER) Randomized Clinical Trial. JAMA Surg. 2021;156(2):129–136. doi:10.1001/jamasurg.2020.5151
Comparing laparoscopic elective sigmoid resection with conservative treatment in improving quality of life of patients with diverticulitis : the Laparoscopic Elective Sigmoid Resection Following Diverticulitis (LASER) randomized clinical trial
|Author:||Santos, Alexandre1; Mentula, Panu1; Pinta, Tarja2;|
1Gastroenterological Surgery, University of Helsinki, 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, Helsinki University Hospital, Helsinki, Finland
|Online Access:||PDF Full Text (PDF, 0.3 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe202103106973
American Medical Association,
|Publish Date:|| 2021-03-10
Importance: Diverticulitis has a tendency to recur and affect quality of life.
Objective: To assess whether sigmoid resection is superior to conservative treatment in improving quality of life of patients with recurrent, complicated, or persistent painful diverticulitis.
Design, Setting, and Participants: This open-label randomized clinical trial assessed for eligibility 128 patients with recurrent, complicated, or persistent painful diverticulitis in 6 Finnish hospitals from September 29, 2014, to October 10, 2018. Exclusion criteria included age younger than 18 years or older than 75 years; lack of (virtual) colonoscopy or sigmoidoscopy data within 2 years, or presence of cancer, contraindication to laparoscopy, or fistula. Outcomes were assessed using intention-to-treat analysis. A prespecified interim analysis was undertaken when 66 patients had been randomized and their 6-month follow-up was assessable. Data were analyzed from June 2018 to May 2020.
Interventions: Laparoscopic sigmoid resection or conservative treatment.
Main Outcomes and Measures: The primary outcome was difference in Gastrointestinal Quality of Life Index (GIQLI) score between randomization and 6 months.
Results: Of 128 patients assessed for eligibility, 90 were randomized (28 male [31%]; mean [SD] age, 54.11 [11.9] years; 62 female [69%]; mean [SD] age, 57.13 [7.6] years). A total of 72 patients were included in analyses for the primary outcome (37 in the surgery group and 35 in the conservative treatment group), and 85 were included in analyses for clinical outcomes (41 in the surgery group and 44 in the conservative treatment group). The difference between GIQLI score at randomization and 6 months was a mean of 11.96 points higher in the surgery group than in the conservative treatment group (mean [SD] of 11.76 [15.89] points vs −0.2 [19.07] points; difference, 11.96; 95% CI, 3.72–20.19; P = .005). Four patients (10%) in the surgery group and no patients in the conservative treatment group experienced major complications (Clavien-Dindo grade III or higher). There were 2 patients (5%) in the surgery group and 12 patients (31%) in the conservative treatment group who had new episodes of diverticulitis within 6 months.
Conclusions and Relevance: In this randomized clinical trial, elective laparoscopic sigmoid resection improved quality of life in patients with recurrent, complicated, or persistent painful diverticulitis but carried a 10% risk of major complications.
Trial Registration: ClinicalTrials.gov Identifier: NCT02174926.
|Pages:||129 - 136|
|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. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
This is an open access article distributed under the terms of the CC-BY License. © 2020 Santos A et al. JAMA Surgery.