AMSTERDAM -- In severe peritonitis, repeat laparotomy done only when the patient's condition demands it cuts down on the number of procedures and medical costs, researchers found.
AMSTERDAM, Aug. 21 -- In severe peritonitis, repeat laparotomy done only when the patient's condition demands it cuts down on the number of procedures and on medical costs, researchers found.
On-demand relaparotomy did not reduce mortality or morbidity, however, said Marja A. Boermeester, M.D., Ph.D., of the Academic Medical Center here, and colleagues.
Their findings, reported in the Aug. 22/29 issue of JAMA, were derived from a randomized, nonblinded clinical trial at two academic and five 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.
Of 232 patients, 112 were randomized to on-demand relaparotomy and 113 to a planned program.
In the planned group, a repeat procedure was done every 36 to 48 hours after the first surgery to allow for inspection, drainage, and peritoneal lavage of the abdominal cavity until findings were negative.
In the on-demand strategy, relaparotomy was done only when there was clinical evidence of lack of improvement with a likely intra-abdominal cause. The decision to do a relaparotomy was made by a multidisciplinary team guided by definitions specified in the protocol.
The researchers found no significant difference in the primary end point of death and/or peritonitis-related illness within a 12-month follow-up (57% on-demand versus 65% planned; P=0.25).
Similarly, there was no significant difference for mortality alone (29% on-demand versus 36% planned; P=0.22) or morbidity alone (40% on-demand versus 44% planned; P=0.58).
Only 42% of the on-demand patients had a relaparotomy compared with 94% of those in the planned procedure group, the researchers reported.
Of those who had a second procedure in the on-demand group, 31% of first relaparotomies were negative versus 66% in the planned group (P
A key challenge for an on-demand strategy is to adequately select patients for relaparotomy and to prevent potential harmful delay in reintervention by adequate and frequent patient monitoring, the researchers suggested.
One of the difficulties in research on secondary peritonitis is the heterogeneity of the study population, regarding severity of disease, etiology, and localization of the infectious focus. These factors make it difficult to extrapolate study results to individual patients in clinical practice.
For this reason, the researchers said, they excluded disease entities, such as pancreatitis, with a substantially different prognosis and requiring different treatment strategies, they wrote.
"Despite a lack of statistically significant improvement in primary clinical outcomes, the substantial reductions in health care utilization and costs with the on-demand strategy suggest that it may be the preferred strategy," the researchers concluded.
In an accompanying editorial, E. Patchen Dellinger, M.D., of the University of Washington in Seattle, wrote that the trial is the best evidence yet that mandatory or scheduled relaparotomy for peritonitis is not helpful except in the obvious case when a first procedure results in retained surgical packing or because the pathology cannot be dealt with completely.
Surgeons should now focus on a search for more accurate and sensitive methods to recognize when a patient will need another intervention, he said. This may include improved understanding of clinical patterns, novel imaging techniques, and possibly new biomarkers.
"Ultimately, though," Dr. Dellinger said, "the diligent attention of the surgical team to the clinical progress of the patient after laparotomy for peritonitis is currently the most effective management technique."
In a second editorial, David R. Flum, M.D., a JAMA contributing editor, and Farhood Fajah, M.D., both of the University of Washington, wrote that data from this "well-designed and conducted" superiority trial will inform the design of future studies in this area.
While the negative results on morbidity and mortality may not be enough to rule out alternative interpretations, they wrote, "the results are consistent with the notion that an on-demand relaparotomy approach may improve outcomes and save health-care resources."
The Dutch researchers had no financial disclosures. The key staff and steering committee for the study received compensation from a Health Care Efficiency Program grant provided by the Dutch Organization for Health Research and Development in the Hague.
Dr. Dellinger, an editorial writer, reported receiving honoraria and grants from a number of companies that manufacture antibiotics, antiseptics, and diagnostic materials related to infection.