麻豆传媒

Laparoscopic sigmoid resection significantly improved quality of life (QOL) in patients with recurrent, complicated, or persistent painful diverticulitis, though was associated with a small but significant risk of major complications, a randomized study showed.

In the so-called LASER trial, the primary outcome of Gastrointestinal Quality of Life Index (GIQLI) score improved by 11.76 points at 6 months for those assigned sigmoidectomy, as compared to a 0.2-point decrease for patients receiving conservative treatment (mean difference 11.96, 95% CI 3.72-20.19, P=0.005), reported Ville Sallinen, MD, PhD, of Helsinki University Hospital in Finland, and colleagues.

"QOL of patients in the surgical group increased significantly more within 6 months and they reported fewer episodes of recurrent diverticulitis and less pain in terms of both frequency and severity at 6 months compared with patients in the conservative treatment group," the authors wrote in .

"Only two patients in the conservative treatment group underwent elective surgery within 6 months and none required emergency surgery," they noted.

Within 6 months, recurrent diverticulitis was reported in 27% of patients in the conservative treatment arm versus 5% of those in the surgery arm (OR 8.0, 95% CI 1.7-38.8, P=0.004). However, 10% of patients undergoing sigmoidectomy experienced major complications such as abscess and anastomotic leakage.

"The groundbreaking LASER trial demonstrates in a randomized controlled fashion that surgical intervention can definitively enhance quality of life for patients with persistent recurrent diverticulitis," Alexander Greenstein, MD, MPH, of the Icahn School of Medicine at Mount Sinai in New York City, told 麻豆传媒.

"While surgery always carries some inherent risk, morbidity results were reassuring in this trial, so surgeons can point favorably to its results when advocating surgery for their patients," added Greenstein, who was not involved in the study.

Sallinen and colleagues noted that diverticular disease is a common disorder, ranging in prevalence from 10% in those younger than 40 years to in those older than 80 years. Acute diverticulitis appears to be on the rise in however.

From 2014 to 2018, LASER (Laparoscopic Elective Sigmoid Resection Following Diverticulitis) randomized 90 patients with recurrent, complicated, or persistent painful diverticulitis to either laparoscopic sigmoid resection or conservative treatment, which consisted of written information on diverticulosis and constipation, a prescription for a fiber supplement, and guidance for increased dietary fiber. The primary outcome analysis included those who filled out GIQLI questionnaires both at baseline and 6 months (n=72).

After exclusions, the analysis of clinical outcomes included 85 patients, 69% of whom were women (mean age 57) and 31% of whom were men (mean age 54). Body mass index was similar in both arms at about 29.

Mean crude GIQLI score at 6 months was higher in the surgical group compared with the non-surgical group (114.92 vs 101.97) for a difference of 12.95 (95% CI 3.98-21.92, P=0.005).

At 6 months, 46% of patients in the surgery arm reported pain versus 68% in the conservative arm.

The results of LASER parallel those of the , the authors noted. DIRECT was an open-label randomized trial reporting a 14.2% increase in 6-month GIQLI scores with colectomy versus standard care. QOL scores at 6 months in the surgical groups of the two trials were 114.9 in LASER and 114.4 in DIRECT, while the conservative treatment groups had scores of 101.97 and 100.4, respectively.

In other studies, Swiss investigators published results earlier this year suggesting that interval resection did not reduce emergency surgery or death over conservative management in complex diverticulitis, while a U.S. analysis reported unexpectedly with elective colectomy for diverticulitis.

Sallinen's group noted several limitations to their study, including the relatively low number of patients and the premature termination owing to the early clear benefit of elective resection. The premature stopping of the trial might have affected the power of the outcomes as well. Also, the trial did not include sham surgery, and hence a possible placebo effect on QOL cannot be ruled out.

Inclusion criteria were relatively strict, the authors added. As patients had to have had at least three recurrent episodes of diverticulitis within 2 years to meet the criteria, it is unclear whether surgery would be beneficial for patients who have less frequent episodes. The number of patients recruited due to one episode of complicated diverticulitis or persistent pain after one episode of diverticulitis was small, preventing subgroup analysis. Moreover, study patients had varying indications for surgery.

Finally, some patients did not respond to QOL questionnaires, and thus the primary outcome was not assessable in all randomized patients, which could have introduced bias.

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