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

Abstract

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Santos reports grants from The Finnish Medical Foundation during the conduct of the study. Dr Sallinen reports grants from Vatsatautien Tutkimussäätiö Foundation, Mary and Georg Ehrnrooth’s Foundation, Martti I. Turunen Foundation, and Helsinki University Hospital research funds during the conduct of the study as well as grants from Academy of Finland, Finnish Cancer Foundation (Syöpäsäätiö), and Finnish Gastroenterological Society and personal fees from Finnish Gastroenterological Society, City of Vantaa, and University of Helsinki outside the submitted work. Dr Scheinin reports personal fees from Johnson & Johnson outside the submitted work. No other disclosures were reported.

Figures

Figure.. CONSORT Flow Chart

CT indicates computed tomography. aOne because of severe obesity and one because of myasthenia gravis. bDid not meet inclusion criteria (right-sided diverticulitis). cCompleted both baseline and 6-month quality of life questionnaires.