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In patients with perforated diverticulitis and peritonitis, primary anastomosis proved superior to Hartmann's procedure for 12-month stoma-free survival and overall morbidity after stoma reversal, European researchers found. Nor were there any significant differences in short-term morbidity and mortality after the index procedure, reported Daniël PV Lambrichts, of Erasmus University Medical Center in Rotterdam, the Netherlands.

The DIVA arm of the LADIES (laparoscopic peritoneal lavage or resection for purulent peritonitis and Hartmann's procedure or resection with primary anastomosis for purulent or fecal peritonitis in perforated diverticulitis) found that 12-month stoma-free survival was significantly better than Hartmann's for patients given primary anastomosis: 94.6% (95% CI 88.7%-100%) versus 71.7% (95% CI 60.1%-83.3%), hazard ratio 2.79 (95% CI 1.86-4.18, log-rank P<0.0001).

"The LADIES trial provides strong support in favor of sigmoidectomy with primary anastomosis as the most appropriate surgical treatment for diverticulitis with purulent or fecal peritonitis in patients who are hemodynamically stable and immunocompetent," the team wrote in . "Combined with existing evidence, these results could fundamentally change current practice and reduce both patient and socioeconomic burden."

Hartmann's procedure, a segmental resection of the sigmoid colon with a temporary end colostomy, was developed almost a century ago as an alternative to abdominoperineal resection for upper rectal tumors, and remains the most common procedure for acute diverticulitis, the authors explained.

Study Details

The multicenter, randomized, open-label, superiority trial was conducted in patients ages 18 to 85 at eight academic hospitals and 34 teaching hospitals in Belgium, Italy, and the Netherlands. During 2010 to 2013, a total of 133 patients with either Hinchey III disease (93 patients) or Hinchey IV disease (40 patients) were allocated one-on-one to Hartmann's procedure (68 patients) or sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy (65 patients).

The patients were well matched in baseline characteristics and analyzed according to a modified intention-to-treat (ITT) principle. After exclusions, the modified ITT population consisted of 66 Hartmann patients and 64 anastomosis patients.

In 17 of the 64 patients assigned to primary anastomosis (27%), no stoma was constructed. Short-term morbidity and mortality were comparable in the two groups. Morbidity affected 29 of 66 Hartmann patients (44%) versus 25 of 64 anastomosis patients (39%) (P=0.60). Two (3%) and four (6%) patients died in the two groups, respectively (P=0.44).

A significantly shorter median time to reversal and postoperative stay after reversal was also observed with anastomosis, the researchers reported. No significant differences emerged on several measures of quality of life, including the EuroQol-5D-3 level, Short Form-36v2, and Gastrointestinal Quality-of-Life Index, at time points from 2 weeks to 12 months.

The authors pointed to other reporting similar favorable outcomes with primary anastomosis. And a 2018 meta-analysis of studies found decreased morbidity rates after stoma reversal for primary anastomosis, while in a 2018 meta-analysis of three Hartmann's procedure and primary anastomosis were found comparable in terms of mortality or overall morbidity, with a lower intra-abdominal abscess risk after the latter procedure.

Additionally, Lambrichts and co-authors noted, the likelihood of reversal of end colostomies after Hartmann's procedure has been reported to be lower (50-60%) than that with closure of defunctioning ileostomies after sigmoidectomy with primary anastomosis (85%), thereby increasing the associated healthcare costs and negatively affecting . Moreover, Hartmann's procedure reversal has been associated with high .

'Relegate to the History Books'

Writing in a related commentary, Sergio A. Acuna, MD, and colleagues from the University of Toronto, said that routine use of Hartmann's procedure for perforated diverticulitis should now be relegated to the history books. "Clinical practice guidelines for the management of perforated diverticulitis should be updated to include stronger recommendations that clearly state that primary anastomosis is the procedure of choice for Hinchey III and Hinchey IV diverticulitis in stable patients," the commentators wrote.

They conceded, however, that surgeons have been hesitant to undertake anastomosis in the setting of purulent or fecal contamination and hence most choose Hartmann's procedure to eliminate concerns about anastomotic leakage.

That hesitancy may explain the findings of a 2019 that found that just 7.6% of patients undergoing emergency colectomy for diverticulitis receive primary anastomosis, while an overwhelming majority, 92.4%, are still managed with Hartmann's procedure.

Study limitations, Lambrichts and co-authors said, include the premature termination and failure to achieve the planned sample size because of low accrual rates. In addition, selection bias might have been present in participants before randomization owing to surgeon or patient preferences.