Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: The SCANDIV Randomized Clinical Trial
2015 (English)In: Journal of the American Medical Association (JAMA), ISSN 0098-7484, E-ISSN 1538-3598, Vol. 314, no 13, 1364-1375 p.Article in journal (Refereed) Published
IMPORTANCE: Perforated colonic diverticulitis usually requires surgical resection, which is associated with significant morbidity. Cohort studies have suggested that laparoscopic lavage may treat perforated diverticulitis with less morbidity than resection procedures.
OBJECTIVE: To compare the outcomes from laparoscopic lavage with those for colon resection for perforated diverticulitis.
DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized clinical superiority trial recruiting participants from 21 centers in Sweden and Norway from February 2010 to June 2014. The last patient follow-up was in December 2014 and final review and verification of the medical records was assessed in March 2015. Patients with suspected perforated diverticulitis, a clinical indication for emergency surgery, and free air on an abdominal computed tomography scan were eligible. Of 509 patients screened, 415 were eligible and 199 were enrolled.
INTERVENTIONS: Patients were assigned to undergo laparoscopic peritoneal lavage (n = 101) or colon resection (n = 98) based on a computer-generated, center-stratified block randomization. All patients with fecal peritonitis (15 patients in the laparoscopic peritoneal lavage group vs 13 in the colon resection group) underwent colon resection. Patients with a pathology requiring treatment beyond that necessary for perforated diverticulitis (12 in the laparoscopic lavage group vs 13 in the colon resection group) were also excluded from the protocol operations and treated as required for the pathology encountered.
MAIN OUTCOMES AND MEASURES: The primary outcome was severe postoperative complications (Clavien-Dindo score >IIIa) within 90 days. Secondary outcomes included other postoperative complications, reoperations, length of operating time, length of postoperative hospital stay, and quality of life.
RESULTS: The primary outcome was observed in 31 of 101 patients (30.7%) in the laparoscopic lavage group and 25 of 96 patients (26.0%) in the colon resection group (difference, 4.7% [95% CI, -7.9% to 17.0%]; P = .53). Mortality at 90 days did not significantly differ between the laparoscopic lavage group (14 patients [13.9%]) and the colon resection group (11 patients [11.5%]; difference, 2.4% [95% CI, -7.2% to 11.9%]; P = .67). The reoperation rate was significantly higher in the laparoscopic lavage group (15 of 74 patients [20.3%]) than in the colon resection group (4 of 70 patients [5.7%]; difference, 14.6% [95% CI, 3.5% to 25.6%]; P = .01) for patients who did not have fecal peritonitis. The length of operating time was significantly shorter in the laparoscopic lavage group; whereas, length of postoperative hospital stay and quality of life did not differ significantly between groups. Four sigmoid carcinomas were missed with laparoscopic lavage.
CONCLUSIONS AND RELEVANCE: Among patients with likely perforated diverticulitis and undergoing emergency surgery, the use of laparoscopic lavage vs primary resection did not reduce severe postoperative complications and led to worse outcomes in secondary end points. These findings do not support laparoscopic lavage for treatment of perforated diverticulitis.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01047462.
Place, publisher, year, edition, pages
2015. Vol. 314, no 13, 1364-1375 p.
Medical and Health Sciences
IdentifiersURN: urn:nbn:se:uu:diva-266451DOI: 10.1001/jama.2015.12076ISI: 000362644700014PubMedID: 26441181OAI: oai:DiVA.org:uu-266451DiVA: diva2:868259
Collaborators: Papp A, Ersson U, Zittel T, Fagerström N, Gustafsson D, Dafnis G, Cornelius M, Egenvall M, Nyström PO, Syk I, Vilhjalmsson D, Påhlman L, Arbman G, Chabok A, Helgeland M, Bondi J, Husby A, Helander R, Kjos A, Gregussen H, Talabani AJ, Tranø G, Nygaard IH, Wiedswang G, Sjo OH, Desserud KF, Norderval S, Gran MV, Pettersen T, Sæther A.
Lars Påhlman tillhör Institutionen för kirurgiska vetenskaper, kolorektalkirurgi.2015-11-102015-11-102016-03-29Bibliographically approved