Laparoscopic lavage offers an alternative to the Hartmann procedure for patients with perforated diverticulitis with purulent peritonitis, suggest the findings of a randomized controlled trial published online January 18 in the Annals of Internal Medicine.
“The benefits of laparoscopic lavage in our trial were a lower risk for any reoperation (acute and elective) and a shorter length of hospital stay during follow-up,” write Anders Thornell, MD, from the University of Gothenburg in Sweden, and colleagues.
The risk for reoperation within a year of the procedure was 59% lower for patients undergoing the laparoscopic procedure than for those undergoing a Hartmann procedure. After 12 months, three patients in the laparoscopy group and 11 patients in the Hartmann had a stoma.
“Stoma reversal is often considered a small and simple procedure, but from a patient perspective, it still is a surgery with subsequent risk for complications,” Thornell and colleagues note. “Although surgery is sometimes necessary, it is always a trauma in itself.”
In this open-label trial known as DILALA, the researchers randomly assigned 43 patients to receive a laparoscopic lavage and 40 patients to undergo an open colon resection and colostomy (the Hartmann procedure). All the patients also “received a passive drain in the pelvis, which was left in place for at least 24 hours,” the study authors report.
The patients, treated at nine hospitals in Sweden and Denmark between February 2010 and February 2014, all had Hinchey grade III perforated diverticulitis with purulent peritonitis, confirmed through laparoscopy. The laparoscopic lavage patients were followed a median 372 days compared with a median 378 days of follow-up for the Hartmann procedure patients.
Although 27.9% of the laparoscopic patients required at least one reoperation within 12 months, 62.5% of the Hartmann patients required a reapportion, translating to a 59% reduced risk for the former (relative risk [RR], 0.41; 95% confidence interval [CI], 0.23 – 0.72; P = .004). Similarly, the analysis adjusted for age, sex, American Society of Anesthesiologists classification, and body mass index showed a 60% lower risk for reoperation, and the per protocol analysis, with 38 laparoscopic patients and 35 Hartmann patients, showed a 72% risk reduction. Approximately 80% of the patients requiring a reoperation needed only one.
“To date, there is little or no knowledge of the biological mechanisms through which laparoscopic lavage could be effective,” the authors state. “Thus, much remains to be clarified.”
The laparoscopic group remained in the hospital a mean 14 days compared with a mean 18 days for the Hartmann group. Each group had six deaths, including two in each group from sepsis related to diverticulitis. The laparoscopic group experienced 27 infectious adverse events, including 14 cases of intra-abdominal abscess, and eight cardiovascular adverse events, including one case of arrhythmia or tachycardia. The Hartmann group, meanwhile, had 18 infectious adverse events, four of which involved intra-abdominal abscess, and 16 cardiovascular adverse events, including nine cases of arrhythmia or tachycardia. Overall adverse events were similar across both groups, as were baseline and follow-up quality-of-life assessment scores.
Determining which procedure is superior depends in part on the endpoints selected, write Tim W. Eglinton, MBChB, MMedSc, and Frank A. Frizelle, MBChB, MMedSc, from the University of Otago at Christchurch in New Zealand, in an accompanying editorial. They describe a French study reported in 2000 that used postoperative peritonitis as an endpoint and two other randomized studies of laparoscopic lavage (Laparoscopic Lavage [LOLA] and the Scandinavian Diverticulitis Trial [SCANDIV]) as lending “support to the principle that resection of the inflammatory focus is better than simple lavage.”
LOLA used a composite endpoint of major morbidity and mortality within 12 months, and SCANDIV used all severe postoperative complications within 90 days as the primary endpoint.
“The seemingly contradictory findings of these 2 recent studies and DILALA reflect the variable end points used to assess the procedures,” write Dr Eglinton and Dr Frizelle. “Unlike the 2 previously reported trials, DILALA categorized reversal of the Hartmann procedure, but not percutaneous abscess drainage, as a reoperation.”
They argue, then, that the results of LOLA, SCANDIV, and DILALA are actually consistent with one another.
“The risk for ongoing intra-abdominal sepsis clearly is higher when the diseased segment is not resected, but this is at the expense of requiring subsequent reversal of the Hartmann procedure,” they write. “What is not clear from any of the studies is which patients with purulent peritonitis (Hinchey grade III) actually require surgery at all.”
The next study, they suggest, might focus on “computed tomography, antibiotics and watchful waiting compared with surgical intervention by either laparoscopic lavage or resection.”
The study was funded by Sahlgrenska University Hospital, Swedish Research Council, the Health and Medical Care Committee of the Regional Executive Board and Region Västra Götaland, Adlerbertska Research Foundation, Alice Swenzons Foundation, Anna-Lisa and Bror Björnsson Foundation, Swedish Society of Medicine, Faith Regen Foundation, Göteborg Medical Society, Sahlgrenska University Hospital Health Technology Assessment Center, Johan & Jacob Söderberg Foundation, Bengt Ihre Foundation, Wilhelm & Martina Lundgren Foundation, Magnus Bergvall Foundation, Ruth and Richard Julin Foundation, Signe and Olof Wallenius Foundation, Adlerbertska Foundation, and Mary von Sydow Foundation. One coauthors has previously received travel funding from Davol. The other authors and the editorialists have disclosed no relevant financial relationships.