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A Randomized Trial

Oddeke van Ruler, MD; Cecilia W. Mahler, MD; Kimberly R. Boer, MSc; E. Ascelijn Reuland, MSc; Hein G. Gooszen, MD, PhD; Brent C. Opmeer, PhD; Peter W. de Graaf, MD, PhD; Bas Lamme, MD, PhD; Michael F. Gerhards, MD, PhD; E. Philip Steller, MD, PhD; J. W. Olivier van Till, MD; Corianne J. A. M. de Borgie, PhD; Dirk J. Gouma, MD, PhD; Johannes B. Reitsma, MD, PhD; Marja A. Boermeester, MD, PhD; for the Dutch Peritonitis Study Group

JAMA. 2007;298(8):865-872.

Context  In patients with severe secondary peritonitis, there are 2 surgical treatment strategies following an initial emergency laparotomy: planned relaparotomy and relaparotomy only when the patient's condition demands it ("on-demand"). The on-demand strategy may reduce mortality, morbidity, health care utilization, and costs. However, randomized trials have not been performed.

Objective  To compare patient outcome, health care utilization, and costs of on-demand and planned relaparotomy.

Design, Setting, and Patients  Randomized, nonblinded clinical trial at 2 academic and 5 regional teaching hospitals in the Netherlands from November 2001 through February 2005. Patients had severe secondary peritonitis and an Acute Physiology and Chronic Health Evaluation (APACHE-II) score of 11 or greater.

Intervention  Random allocation to on-demand or planned relaparotomy strategy.

Main Outcome Measures  The primary end point was death and/or peritonitis-related morbidity within a 12-month follow-up period. Secondary end points included health care utilization and costs.

Results  A total of 232 patients (116 on-demand and 116 planned) were randomized. One patient in the on-demand group was excluded due to an operative diagnosis of pancreatitis and 3 in each group withdrew or were lost to follow-up. There was no significant difference in primary end point (57% on-demand [n = 64] vs 65% planned [n = 73]; P = .25) or in mortality alone (29% on-demand [n = 32] vs 36% planned [n = 41]; P = .22) or morbidity alone (40% on-demand [n = 32] vs 44% planned [n = 32]; P = .58). A total of 42% of the on-demand patients had a relaparotomy vs 94% of the planned relaparotomy group. A total of 31% of first relaparotomies were negative in the on-demand group vs 66% in the planned group (P <.001). Patients in the on-demand group had shorter median intensive care unit stays (7 vs 11 days; P = .001) and shorter median hospital stays (27 vs 35 days; P = .008). Direct medical costs per patient were reduced by 23% using the on-demand strategy.

Conclusion  Patients in the on-demand relaparotomy group did not have a significantly lower rate of death or major peritonitis-related morbidity compared with the planned relaparotomy group but did have a substantial reduction in relaparotomies, health care utilization, and medical costs.

Trial Registration  http://isrctn.org Identifier: ISRCTN51729393

Author Affiliations: Department of Surgery (Drs van Ruler, Mahler, van Till, Gouma, and Boermeester and Ms Reuland), and Department of Clinical Epidemiology, Biostatistics and Bioinformatics (Drs Opmeer, de Borgie, and Reitsma and Ms Boer), Academic Medical Center, Amsterdam; Department of Surgery, University Medical Center Utrecht, Utrecht (Dr Gooszen); Department of Surgery, Reinier de Graaf Gasthuis, Delft (Dr de Graaf); Department of Surgery, Gelre Hosptal, Apeldoorn (Dr Lamme); Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam (Dr Gerhards); and Department of Surgery, Sint Lucas Andreas Hospital, Amsterdam (Dr Steller), the Netherlands.

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