Elective laparoscopic sigmoid resection was found to significantly improve patient quality of life (QOL) and reduce pain in individuals with recurrent, complicated, or persistent painful diverticulitis. These findings, from the multicenter, prospective, open-label randomized LASER trial, were published in JAMA Surgery.
The intention-to-treat analysis included 85 patients with recurrent, complicated, or persistent painful diverticulitis from 6 hospitals in Finland between September 29, 2014 and October 10, 2018. In the LASER trial (ClinicalTrials.gov identifier: NCT02174926), patients were randomly assigned to receive either laparoscopic sigmoid resection (n=41) or conservative treatment (n=44).
Patients who received conservative treatment were educated on diverticulosis and constipation, advised to increase their fiber consumption, and prescribed a fiber supplement. Patients in the surgery arm received conservative treatment after their respective procedures. The trial’s primary end point was the difference in the Gastrointestinal Quality of Life Index (GIQLI) score at baseline and at 6 months. Patient scores on the 36-Item Short Form Health Survey (SF-36) at 6, 12, 24, 48, and 96 months was a secondary end point. Most patients (69%) were women, with a mean age of 57.08 years (standard deviation, 7.68.)
At 6 months, only 72 of the participants (surgery, n=37; conservative, n=35) completed the follow-up assessment and were subsequently included in the primary outcome analyses. Notably, the GIQLI score increased significantly in the surgery group, rising by a mean of 11.96 points compared with the conservative treatment group (SD, 15.89; P =.005). The conservative group GIQLI scores did not increase between baseline and 6 months (mean difference, -0.2; SD, 19.07 points).
The mental component of the SF-36 was higher in the surgery cohort (median, 55.14 points; interquartile range [IQR], 51.38-57.24) than the conservative cohort (median, 47.68 points; IQR, 41.27-56.82; P =.02). The median physical SF-36 component did not differ significantly between the surgery or conservative groups (51.52 vs 42.19; P =.06).
Fewer patients in the surgical group reported experiencing pain at 6 months (46% vs 68%; P =.04).Despite the significant differences in pain and QOL, no clinically meaningful difference was observed with respect to patient satisfaction with the assigned treatment (P =.23).
Within 6 months, diverticulitis symptoms was found to recur in 2 patients in the surgery group and 12 patients in the conservative group (odds ratio, 8.0; 95% CI, 1.7-38.8; P =.004). Recurrences were more common among patients who had diverticulosis confined to the sigmoid or descending colon.
Four patients (10%) in the surgery group and no patients in the conservative treatment group experienced major complications (Clavien-Dino grade ≥3). This 10% rate of Clavien-Dino complications was based on the following events: 1 patient was converted to open surgery due to intra-abdominal adhesions, 2 patients had postoperative abscesses, and 2 patients had anastomotic leakage requiring emergency laparotomy and transversostomy or emergency laparoscopic lavage and drainage with transversostomy. “Otherwise, postoperative complications were minor,” the investigators said.
This study may have been limited by its premature termination, which might have affected the power of the outcomes. However, the investigators felt it unethical to continue the study protocol because the elective surgery treatment was having a clear effect on QOL.
The study authors concluded that elective laparoscopic sigmoidectomy significantly improved QOL and reduced pain. This procedure, however, did not come without the risk for “major complications” (10%). “Further outcomes of the LASER trial will be reported when longer follow-up data are assessable,” they stated.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of the authors’ disclosures.
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. Published online November 18, 2020. doi:10.1001/jamasurg.2020.5151