Health economic analysis of laparoscopic lavage versus Hartmann's procedure for diverticulitis in the randomized DILALA trial

J Gehrman, E Angenete, I Björholt, D Bock, J Rosenberg, E Haglind, J Gehrman, E Angenete, I Björholt, D Bock, J Rosenberg, E Haglind

Abstract

Background: Open surgery with resection and colostomy (Hartmann's procedure) has been the standard treatment for perforated diverticulitis with purulent peritonitis. In recent years laparoscopic lavage has emerged as an alternative, with potential benefits for patients with purulent peritonitis, Hinchey grade III. The aim of this study was to compare laparoscopic lavage and Hartmann's procedure with health economic evaluation within the framework of the DILALA (DIverticulitis - LAparoscopic LAvage versus resection (Hartmann's procedure) for acute diverticulitis with peritonitis) trial.

Methods: Clinical effectiveness and resource use were derived from the DILALA trial and unit costs from Swedish sources. Costs were analysed from the perspective of the healthcare sector. The study period was divided into short-term analysis (base-case A), within 12 months, and long-term analysis (base-case B), from inclusion in the trial throughout the patient's expected life.

Results: The study included 43 patients who underwent laparoscopic lavage and 40 who had Hartmann's procedure in Denmark and Sweden during 2010-2014. In base-case A, the difference in mean cost per patient between laparoscopic lavage and Hartmann's procedure was €-8983 (95 per cent c.i. -16 232 to -1735). The mean(s.d.) costs per patient in base-case B were €25 703(27 544) and €45 498(38 928) for laparoscopic lavage and Hartmann's procedure respectively, resulting in a difference of €-19 794 (95 per cent c.i. -34 657 to -4931). The results were robust as demonstrated in sensitivity analyses.

Conclusion: The significant cost reduction in this study, together with results of safety and efficacy from RCTs, support the routine use of laparoscopic lavage as treatment for complicated diverticulitis with purulent peritonitis.

© 2016 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.

References

    1. Morris AM, Regenbogen SE, Hardiman KM, Hendren S. Sigmoid diverticulitis: a systematic review. JAMA 2014; 311: 287–297.
    1. Hinchey EJ, Schaal PG, Richards GK. Treatment of perforated diverticular disease of the colon. Adv Surg 1978; 12: 85–109.
    1. Jacobs DO. Clinical practice. Diverticulitis. N Engl J Med 2007; 357: 2057–2066.
    1. McDermott FD, Collins D, Heeney A, Winter DC. Minimally invasive and surgical management strategies tailored to the severity of acute diverticulitis. Br J Surg 2014; 101: e90–e99.
    1. Vermeulen J, Coene PP, Van Hout NM, van der Harst E, Gosselink MP, Mannaerts GH et al Restoration of bowel continuity after surgery for acute perforated diverticulitis: should Hartmann's procedure be considered a one‐stage procedure? Colorectal Dis 2009; 11: 619–624.
    1. Myers E, Hurley M, O'Sullivan GC, Kavanagh D, Wilson I, Winter DC. Laparoscopic peritoneal lavage for generalized peritonitis due to perforated diverticulitis. Br J Surg 2008; 95: 97–101.
    1. Alamili M, Gogenur I, Rosenberg J. Acute complicated diverticulitis managed by laparoscopic lavage. Dis Colon Rectum 2009; 52: 1345–1349.
    1. Angenete E, Thornell A, Burcharth J, Pommergaard HC, Skullman S, Bisgaard T et al Laparoscopic lavage is feasible and safe for the treatment of perforated diverticulitis with purulent peritonitis: the first results from the randomized controlled trial DILALA. Ann Surg 2016; 263: 117–122.
    1. Schultz JK, Yaqub S, Wallon C, Blecic L, Forsmo HM, Folkesson J et al; SCANDIV Study Group . Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: the SCANDIV randomized clinical trial. JAMA 2015; 314: 1364–1375.
    1. Vennix S, Musters GD, Mulder IM, Swank HA, Consten EC, Belgers EH et al; Ladies trial collaborators. Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis: a multicentre, parallel‐group, randomised, open‐label trial. Lancet 2015; 386: 1269–1277.
    1. Thornell A, Angenete E, Bisgaard T, Bock D, Burcharth J, Heath J et al Laparoscopic lavage for perforated diverticulitis with purulent peritonitis: a randomized trial. Ann Intern Med 2016; 164: 137–145.
    1. Oberkofler CE, Rickenbacher A, Raptis DA, Lehmann K, Villiger P, Buchli C et al A multicenter randomized clinical trial of primary anastomosis or Hartmann's procedure for perforated left colonic diverticulitis with purulent or fecal peritonitis. Ann Surg 2012; 256: 819–826.
    1. Thornell A, Angenete E, Gonzales E, Heath J, Jess P, Lackberg Z et al; Group Scandinavian Surgical Outcomes Research, SSORG. Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial. Trials 2011; 12: 186.
    1. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D et al Consolidated Health Economic Evaluation Reporting Standards (CHEERS) – explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Health 2013; 16: 231–250.
    1. Björholt I, Janson M, Jonsson B, Haglind E. Principles for the design of the economic evaluation of COLOR II: an international clinical trial in surgery comparing laparoscopic and open surgery in rectal cancer. Int J Technol Assess Health Care 2006; 22: 130–135.
    1. Thornell A, Angenete E, Haglind E. Perforated diverticulitis operated at Sahlgrenska University Hospital 2003–2008. Dan Med Bull 2011; 58: A4173.
    1. Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stoddart GL. Methods for the Economic Evaluation of Health Care Programmes (3rd edn). Oxford University Press: Oxford, 2005.
    1. Salem L, Anaya DA, Roberts KE, Flum DR. Hartmann's colectomy and reversal in diverticulitis: a population‐level assessment. Dis Colon Rectum 2005; 48: 988–995.
    1. Shaikh S, Krukowski ZH. Outcome of a conservative policy for managing acute sigmoid diverticulitis. Br J Surg 2007; 94: 876–879.
    1. Broderick‐Villa G, Burchette RJ, Collins JC, Abbas MA, Haigh PI. Hospitalization for acute diverticulitis does not mandate routine elective colectomy. Arch Surg 2005; 140: 576–581.
    1. Glick H, Doshi JA, Sonnad SS, Polsky D. Economic Evaluation in Clinical Trials (2nd edn). Oxford University Press: Oxford, 2014.
    1. Barber JA, Thompson SG. Analysis of cost data in randomized trials: an application of the non‐parametric bootstrap. Stat Med 2000; 19: 3219–3236.
    1. O'Hagan A, Stevens JW. On estimators of medical costs with censored data. J Health Econ 2004; 23: 615–625.
    1. Lin DY, Feuer EJ, Etzioni R, Wax Y. Estimating medical costs from incomplete follow‐up data. Biometrics 1997; 53: 419–434.
    1. Bang H, Tsiatis AA. Estimating medical costs with censored data. Biometrika 2000; 87: 329–343.
    1. . LapLAND Laparoscopic Lavage for Acute Non‐Faeculant Diverticulitis. [accessed 3 December 2015].
    1. Binda GA, Serventi A, Altomare DF. Multicentre observational study of the natural history of left‐sided acute diverticulitis (Br J Surg 2012; 99: 276–285) (Br J Surg 2012; 99: 285–286). Br J Surg 2012; 99: 738.
    1. Crawshaw BP, Chien HL, Augestad KM, Delaney CP. Effect of laparoscopic surgery on health care utilization and costs in patients who undergo colectomy. JAMA Surg 2015; 150: 410–415.
    1. Taylor GW, Jayne DG, Brown SR, Thorpe H, Brown JM, Dewberry SC et al Adhesions and incisional hernias following laparoscopic versus open surgery for colorectal cancer in the CLASICC trial. Br J Surg 2010; 97: 70–78.

Source: PubMed

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