Comparison of on-demand vs planned relaparotomy strategy in patients with severe peritonitis: a randomized trial.
BACKGROUND
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.


METHODS
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.


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


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
http://isrctn.org Identifier: ISRCTN51729393.
van Ruler
Oddeke
O
Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.
Mahler
Cecilia W
CW
Boer
Kimberly R
KR
Reuland
E Ascelijn
EA
Gooszen
Hein G
HG
Opmeer
Brent C
BC
de Graaf
Peter W
PW
Lamme
Bas
B
Gerhards
Michael F
MF
Steller
E Philip
EP
van Till
J W Olivier
JW
de Borgie
Corianne J A M
CJ
Gouma
Dirk J
DJ
Reitsma
Johannes B
JB
Boermeester
Marja A
MA
D018806:APACHE; D000368:Aged; D004630:Emergencies; D005260:Female; D017048:Health Care Costs; D006296:Health Services / Q000706:statistics & numerical data; D006801:Humans; D007813:Laparotomy / Q000009:adverse effects / Q000191:economics / Q000592:standards; D008297:Male; D008875:Middle Aged; D009017:Morbidity; D009426:Netherlands; D010043:Outcome and Process Assessment, Health Care; D010538:Peritonitis / Q000150:complications / Q000401:mortality / Q000601:surgery*; D012086:Reoperation / Q000009:adverse effects / Q000191:economics / Q000592:standards; D016019:Survival Analysis