Elective laparoscopic sigmoid resection improves quality of life and decreases the risk of recurrence of diverticulitis compared with conservative treatment, according to 2-year follow-up results from a multicenter, randomized trial.
The results "may help in decision-making regarding when to proceed to elective surgery for diverticulitis," write Alexandre Santos, MD, a gastroenterological surgeon at the University of Helsinki and Helsinki University Hospital in Finland, and colleagues.
The findings, published online April 19 in JAMA Surgery, are the latest from the Laparoscopic Elective Sigmoid Resection vs Conservative Treatment Following Diverticulitis (LASER) clinical trial. The 6-month results were published in 2020.
Because guidelines recommend a tailored approach for managing diverticulitis, patient counseling regarding treatment choices varies, co-author Ville Sallinen, MD, PhD, assistant professor and consultant surgeon at Helsinki University Hospital, told Medscape Medical News.
"What this study brings to the table is solid evidence of when the treatment should be offered," Sallinen said. "The inclusion criteria for the LASER trial was at least three episodes of diverticulitis within 2 years, and with this threshold, the surgery was beneficial."
The risk of recurrence of episodes of diverticulitis is largely based on the number of earlier episodes, the researchers note.
"While patients with first-time uncomplicated diverticulitis have only a 30% risk of recurrence within 5 years, patients who have had 3 or more earlier cases of diverticulitis have about an 80% chance of another recurrence," they write.
Elective sigmoid resection and conservative treatment are options for patients, but current guidelines don't clearly define the indications for surgery, and more research was necessary to fill holes in the studies, they add.
LASER is a parallel, open-label individually randomized trial comparing elective sigmoid resection to conservative treatment for patients with recurrent, complicated, or persistent, painful diverticulitis.
The trial was conducted in five Finnish hospitals between September 2014 and October 2018. This follow-up study evaluated diverticulitis recurrence, Gastrointestinal Quality of Life Index (GIQLI) score, and other measures at 24 months.
Ninety patients (31% men; average age, 54 years for men, 57 years for women) were randomly selected in a 1:1 ratio to undergo either elective surgery or conservative treatment (patient education and fiber supplements). After exclusions, 41 patients in the surgery group and 44 in the conservative management group were included in the intention-to-treat analyses.
Of those 85 patients, 75 were available for assessment of quality-of-life outcomes at 12 months, and 70 were available for assessment of such outcomes at 24 months; 79 were available for evaluation of recurrence outcomes at 12 months, and 78 were available for such evaluation at 24 months.
Within 24 months, 25 patients (61%) in the conservative treatment group experienced recurrence of diverticulitis, compared with four patients (11%) in the surgery group.
In the surgery group, 4 of 41 patients (10%) experienced major postoperative complications within 24 months; in the conservative group, and 2 of 44 (5%) experienced such complications.
Importantly, eight patients (18%) in the conservative group crossed over and underwent sigmoid resection within 2 years.
The mean GIQLI score at 12 months was 9.51 points higher in the surgery group (118.54 vs 109.03; 95% CI, 0.83 – 18.18; P = .03). That effect dropped off in the surgery group, and the mean GIQLI score was similar between the groups at 24 months.
The drop-off was likely due to the fact that 18% of patients in the conservative arm crossed over to surgery, write Susanna S. Hill, MD, with the Department of Surgery, the University of Minnesota, in Minneapolis, and Jennifer S. Davids, MD, Department of Surgery, Boston University Chobanian and Avedisian School of Medicine, Boston, Massachusetts, in an invited commentary.
However, they note that "a per-protocol analysis based on treatment found higher GIQLI scores in the surgery group that persisted at both 12 and 24 months."
According to the study, the post hoc, per-protocol analyses included only the patients who received their allocated treatment and didn't cross over. The average GIQLI score was 11.27 points higher in the surgery group compared to the conservative treatment group at 12 months (mean, 119.42 [SD, 17.98] vs 108.15 [19.28]; 95% CI, 2.24 – 20.29; P = .02) and 10.43 points higher at 24 months (117.24 [15.51] vs 106.82 [18.94]; 95% CI, 1.52 – 19.33; P = .02).
An important limitation is heterogeneity in the study population, which included patients with recurrent uncomplicated episodes, complicated diverticulitis (excluding stricture and fistula), and persistent pain, Hill and Davids write in their commentary.
"This broad range of symptomatology and small sample size precludes our ability to draw conclusions about outcome based on disease presentation, which is key to patient counseling," they write.
Almost 80% of the patients included in the trial had frequently recurring uncomplicated diverticulitis, so the results mostly apply to those patients, Sallinen said.
"A small minority had persistent pain (6%), and some patients also had had an episode of complicated diverticulitis (27%). These three phenomena often coincide, rather than occur alone," he added.
Overall, the study shows that surgery is "very effective" in preventing recurrences and improving quality of life, Sallinen said.
"On the other hand, continuing with conservative treatment is safe, and recurrent episodes of diverticulitis are usually mild. However, if they decrease quality of life, surgery is indicated," he added.
The decision to proceed to elective sigmoid resection "needs to be made together with the patient using shared decision-making and considering the benefits and harms of both surgery and conservative treatment," the researchers write.
The study was funded by Vatsatautien Tutkimussäätiö Foundation, the Mary and Georg Ehrnrooth's Foundation, the Martti I. Turunen Foundation, the Finnish Medical Foundation, and the Helsinki University Hospital. Santos received grants from the Finnish Medical Foundation during the conduct of the study. Co-author Scheinin has received personal fees from Johnson & Johnson outside the submitted work. Sallinen has received grants from the Vatsatautien Tutkimussäätiö Foundation, the Mary and Georg Ehrnrooth's Foundation, and the Martti I. Turunen Foundation; he received research funds from Helsinki University Hospital during the conduct of the study, as well as grants from the Academy of Finland, the Finnish Cancer Foundation (Syöpäsäätiö), the Sigrid Juselius Foundation, and the Finnish Gastroenterological Society; and he received personal fees from the Finnish Gastroenterological Society, the City of Vantaa, and the University of Helsinki outside the submitted work. Hill and Davids have disclosed no relevant financial relationships.
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.
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