By Will Boggs MD
NEW YORK (Reuters Health) - 24/6/2019
For stable patients with perforated diverticulitis and peritonitis, sigmoidectomy with primary anastomosis provides better outcomes than does Hartmann's procedure, according to results from the LADIES trial.
"Most interestingly, we found an evident difference in our study's primary endpoint of 12-month stoma-free survival, in favor of primary anastomosis," said Daniel P. V. Lambrichts from Erasmus University Medical Center, in Rotterdam, the Netherlands.
"This, in our opinion, is an important endpoint and outcome, as it reflects both the likelihood of stoma reversal as well as the risk of mortality," he told Reuters Health by email.
Hartmann's procedure (resection and colostomy construction) is favored by most surgeons for treating perforated diverticulitis with purulent or fecal peritonitis, Lambrichts and colleagues note in The Lancet Gastroenterology and Hepatology, online June 6. But several recent studies have suggested that sigmoidectomy with primary anastomosis provides comparable postoperative mortality and morbidity, they add.
Lambrichts and teams at 34 teaching hospitals in Belgium, Italy and the Netherlands compared Hartmann's procedure versus primary anastomosis in a randomized, open-label trial of 130 patients.
Among the 64 patients in the primary anastomosis group, 12-month stoma-free survival (94.6%) was significantly better than that among the 66 patients who underwent Hartmann's procedure (71.7%).
Median time to being stoma-free was significantly shorter in the primary anastomosis group (101 days) than in the Hartmann's procedure group (186 days).
Primary anastomosis was associated with superior stoma-free survival both in patients with Hinchey III (purulent peritonitis) and in patients with Hinchey IV (fecal peritonitis) disease.
Short-term postoperative outcomes did not differ between the two procedures, and mortality was not significantly different in patients assigned to Hartmann's procedure versus primary anastomosis.
Among the patients who underwent stoma reversal (38/46 in the primary anastomosis group and 44/65 in the Hartmann's procedure group), overall morbidity was significantly lower in the primary anastomosis group.
There were no significant differences between the groups in quality of life.
"Our study, in addition to the existing evidence, provides novel and strong support in favor of primary anastomosis for the treatment of perforated diverticulitis with purulent or fecal peritonitis," Lambrichts said. "However, adequate patient selection still remains of paramount importance, and the results of this study should be interpreted within the context of the inclusion criteria of our study. Hence, importantly, our message applies to hemodynamically stable and immunocompetent patients."
"Currently, for the treatment of these patients, Hartmann's procedure often still remains the favored procedure," he said. "Thus, we hope that our findings help to move away from the Hartmann's procedure as routine choice and move towards primary anastomosis as optimal approach."
Dr. Nancy N. Baxter of Saint Michael's Hospital, in Toronto, Canada, who co-authored a linked editorial, told Reuters Health by email, "The results reinforced what the previous 3 trials on this topic have shown - that performing a resection with primary anastomosis for perforated diverticulitis in a stable patient has similar morbidity and mortality compared to the Hartmann's procedure. Patients treated with an anastomosis, however, are more likely to avoid a stoma entirely, or if one is required, the stoma is more likely to be reversed with fewer complications related to the reversal procedure."
"For surgeons not familiar with studies in this area, this may be quite surprising, as in the past an anastomosis has been considered 'risky' in this scenario and because of this, the vast majority of patients with perforated diverticulitis are treated with resection and an end colostomy," she said. "This is the largest published trial for this question and therefore increases our confidence in these results."
"We hope the results of the trial encourage surgeons to change their default operation for perforated diverticulitis in stable patients from the Hartmann's procedure to sigmoidectomy with primary anastomosis," Dr. Baxter said. "The Hartmann's procedure leads to more patients having permanent stomas, which impacts their quality of life."
"The Hartmann's procedure should be reserved for cases where operating time needs to be kept to a minimum, such as in patients who are hemodynamically unstable," she said. "For these patients, other options, such as temporizing or damage-control procedures, could also be considered."
Dr. Baxter added, "Perforated diverticulitis requiring emergency surgery is relatively uncommon, and all the trials in this area struggled to recruit their target sample size. We have optimized the use of data available from these 4 trials by conducting a meta-analysis which strengthens these conclusions. While taken together, we cannot rule out that a small difference in mortality exists between the two approaches, there is no indication from the trials or from data from observational studies that the risk is increased by performing an anastomosis."
"There are no ongoing trials or additional trials being planned trials on this topic - the results we have available should be used to change the current practice," she said.
Lancet Gastroenterol Hepatol 2019.