Sigmoid Resection vs Conservative Treatment After Diverticulitis: Prespecified 4-Year Analysis of the LASER Randomized Clinical Trial.

IMPORTANCE

Laparoscopic elective sigmoid resection is a treatment option for patients with recurring, persistent painful, or complicated diverticulitis, but outcomes of surgery compared with conservative treatment are unclear in long-term follow-up.

OBJECTIVE

To compare quality-of-life (QOL), complication, and recurrence outcomes of surgery vs conservative treatment in patients with recurring, persistent painful, or complicated diverticulitis.

DESIGN, SETTING, AND

PARTICIPANTS

The open-label Laparoscopic Elective Sigmoid Resection Following Diverticulitis (LASER) randomized clinical trial was conducted in 6 Finnish hospitals. Ninety patients with recurring, persistent painful, or complicated diverticulitis were randomized (1:1) to elective sigmoid resection or conservative treatment from September 2014 to October 2018. Herein, outcomes are reported at 4-year follow-up using the intention-to-treat principle. Data analysis for this 4-year follow-up was performed from October 2023 to November 2024.

INTERVENTIONS: Laparoscopic elective sigmoid resection vs conservative treatment.

MAIN OUTCOMES AND MEASURES: Secondary outcomes, such as Gastrointestinal Quality of Life Index (GIQLI) scores, complications, and recurrences, within 4 years are reported using intention-to-treat and post hoc per-protocol analyses.

RESULTS

Of 90 enrolled patients (28 male [31%] with mean [SD] age of 54.11 [11.9] years; 62 female [69%] with mean [SD] age of 57.13 [7.6] years), 45 were randomized to elective sigmoid resection and 45 to conservative treatment. Among those randomized to conservative treatment, 14 of 44 (32%) underwent sigmoid resection within 4 years (patients with lower QOL on average). The mean (SD) GIQLI score was 115.3 (17.8) in the surgery group vs 109.8 (19.8) in the conservative treatment group (mean difference, 5.54 [95% CI, -2.98 to 14.06]) at 4 years. Recurrence of diverticulitis occurred in 6 of 38 patients (16%) (4 [10%] after surgery) in the surgery group vs 34 of 37 patients (92%) in the conservative treatment group. Severe postoperative complications occurred in 4 patients (10%) in the surgery group vs 5 patients (11%) in the conservative treatment group.

CONCLUSIONS AND RELEVANCE: High crossover rates from conservative treatment to surgery indicate that patients with low QOL in the conservative treatment group often require surgical intervention; elective sigmoid resection did not improve QOL compared with conservative treatment in 4-year follow-up, even though it was effective in preventing recurrences of diverticulitis and did not lead to increased rates of postoperative complications. Upfront surgery may be preferable in patients with low QOL, but initial conservative treatment is an option for patients with near-normal QOL.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02174926.