TY - JOUR
T1 - Comparison of on-demand vs planned relaparotomy strategy in patients with severe peritonitis: a randomized trial
AU - van Ruler, Oddeke
AU - Mahler, Cecilia W.
AU - Boer, Kimberly R.
AU - Reuland, E. Ascelijn
AU - Gooszen, Hein G.
AU - Opmeer, Brent C.
AU - de Graaf, Peter W.
AU - Lamme, Bas
AU - Gerhards, Michael F.
AU - Steller, E. Philip
AU - van Till, J. W. Olivier
AU - de Borgie, Corianne J. A. M.
AU - Gouma, Dirk J.
AU - Reitsma, Johannes B.
AU - Boermeester, Marja A.
PY - 2007
Y1 - 2007
N2 - 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
AB - 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
U2 - https://doi.org/10.1001/jama.298.8.865
DO - https://doi.org/10.1001/jama.298.8.865
M3 - Article
C2 - 17712070
SN - 0098-7484
VL - 298
SP - 865
EP - 872
JO - JAMA
JF - JAMA
IS - 8
ER -