Re-Laparotomy for Severe Intra-Abdominal Infections

Abstract

Background:

The role of re-laparotomy in the management of intra-abdominal infection remains controversial. Two strategies have been used: Planned re-laparotomy or laparotomy on demand.

Methods:

A review of the literature on this controversial subject was performed.

Results:

Although in the past, planned re-laparotomy made sense for ensuring source control, improvements in imaging, intensive care therapy, and percutaneous interventions may have shifted the balance toward the laparotomy-on-demand strategy. Regardless of strategy, the rate of negative laparotomy remains high (>30%). Randomized trials are not available to provide definitive evidence, and clinical judgment continues to be the basis for decision making.

Conclusions:

Further work to develop more specific clinical tools and criteria to improve the accuracy of diagnosis may lead to use of the laparotomy-on-demand strategy rather than planned re-laparotomy. At this time, there is no good clinical evidence to support one strategy over the other from a mortality standpoint.

Intra-abdominal sepsis continues to be a difficult diagnostic and management challenge. Intra-abdominal infections are associated with a high mortality rate (20–65%), substantial morbidity, and long hospitalizations leading to extensive health care utilization, often with poor outcomes [1 –3]. Despite improvements in intensive care therapies, recognition and management of multiple organ dysfunction syndrome (MODS), availability of antibiotics, and better imaging techniques, mortality rates for intra-abdominal sepsis have not improved over the last several decades. Intra-abdominal sepsis occurs in approximately 12–16% of patients undergoing elective abdominal surgery in the United States [1, 2].

Whereas the main tenants of therapy, including early antibiotics, source control of the infection, and supportive care to maintain organ function are well established, the surgical management remains controversial. After the initial laparotomy, there are two re-laparotomy strategies to eliminate persistent peritonitis or a new infectious focus: Planned and on-demand.

Planned laparotomy was the initial strategy for dealing with secondary peritonitis and gained a strong foothold in the 1980s. This method involves a planned return to the operating room every 24–48 h after the initial procedure for additional washouts until the abdomen is macroscopically clean, and all findings are negative. The proposed benefits of this strategy are early detection of intra-abdominal infection, fewer adhesions making exploration easier, better source control, and avoidance of abscess development. Proponents of this strategy believe that earlier laparotomy and removal of any infected source may prevent MODS and its associated deaths. Opponents of planned laparotomy suggest that it has a higher complication rate, exposes patients to potentially unneeded surgery, leads to higher cost and healthcare utilization, and may actually cause inflammation and MODS.

“Laparotomy on demand” refers to a selective process in which clinical indicators and clinician judgment lead to the decision for re-operation. Proponents of this strategy favor the lower number of negative laparotomies, the ability to use alternative management techniques (imaging, percutaneous interventions), and lower cost and health care utilization. By using clinical indicators to identify patients at higher risk for intra-abdominal sepsis, the number of patients needing re-laparotomy is reduced significantly. This avoids the stress of multiple potentially unnecessary operations, which may themselves increase the risk of MODS. Opponents of this strategy are concerned that longer intervals before re-operation and failure to recognize clinical signs lead to the development of MODS prior to re-operation and increase the mortality rate.

The decision for or against re-laparotomy is clear when patients are at either end of the clinical spectrum. Thus, there is general agreement that patients with Acute Physiology and Chronic Health Evaluation (APACHE) II scores < 10 points do not need planned laparotomy, whereas when certain criteria are in place, re-laparotomy is mandatory. These include pathology not completely resected at original operation, damage control, open abdomen, and packs left in the abdomen. It is the group that lies in between for which the debate continues over planned vs. on-demand laparotomy. The goal is to identify patients with surgically treatable disease before they develop MODS while avoiding a high negative laparotomy rate, exposing patients to unneeded procedures.

Review of Literature

Although there have been many studies published in support of each strategy, most have been retrospective with only one small randomized controlled trial [3]. Table 1 lists some of these studies comparing planned re-laparotomy with an on-demand approach. We discuss some of these in more detail in this section. Analyzing and comparing these studies has proved challenging because of the lack of a unified definition of the disease and variation in the severity of illness and the patient population. In 1990, the Joint Working Party of the Surgical Infection Society (SIS) proposed a definition for intra-abdominal infection as well as prognostic criteria and outcome measures [2]. They defined intra-abdominal infection as one accompanied by clinical signs of peritonitis as well as microbiologic confirmation. Acute Physiology and Chronic Health Evaluation II scores were believed to best approximate disease severity so as to be comparable across studies, and death, time to death recovery, and time to recovery were proposed as outcome measures. The Joint Working Party, among others called for a randomized trial to help clarify the appropriate management of secondary peritonitis and determine whether planned or on-demand laparotomy was superior [2].

Table 1.

Selected studies Comparing Planned Re-Laparotomy with On-Demand Approach

			Number of patients
Study	Study type	Year	Planned	On demand	Mortality ^a
Andrus et al. [16]	Retrospective	1986	34	43	No difference
Penninckx et al. [13]	Retrospective	1990	44	9	Significantly lower with planned approach
Hau et al. [5]	Matched retrospective	1995	38	38	No difference
Lamme et al. [9]	Meta-analysis of 8 studies (5, 10–16)	2002	286	980	No difference
Rakic et al. [17]	Prospective analysis of two hospitals	2005	31	34	No difference
Lamme et al. [18]	Retrospective	2004	81	197	Significantly lower with on-demand approach
van Ruler et al. [3]	Randomized	2007	233	113	No difference

Authors' conclusions.

Identifying patients at risk for persistent intra-abdominal sepsis has been a main goal of the published studies. It is clear that MODS is associated with a higher mortality rate and that preventing progression to MODS will improve outcomes. Multiple organ dysfunction also was found to be a major predictor of morbidity and death by Hinsdale et al. [4], who in 1984 looked retrospectively at 87 re-laparotomies for patients with sepsis. The authors found a 43% mortality rate and concluded that clinical criteria and opinion were as good as any radiologic study. Additionally, one-half of the patients with MODS who were re-explored had negative laparotomies, with a 100% mortality rate in this group. It was concluded that MODS alone could be the reason for re-exploration, but, as others have suggested, it may mean intervention is too late.

A matched retrospective cohort study by Hau et al. in 1995 [5], using data from 18 hospitals, compared 38 patients who underwent planned re-laparotomy with 38 patients undergoing re-laparotomy on demand. The investigators found no difference in the mortality rate (21% vs. 13%) and an increase in MODS and infections in the planned re-laparotomy group. This led to the conclusion that planned re-laparotomy itself may set off inflammatory cascades leading to MODS. The authors concluded that the decision for planned re-laparotomy should be evaluated carefully but made no recommendation. This study also contradicts the theory that delay in re-laparotomy seen with the on-demand approach is harmful.

In 2003, Holzheimer at al. [6] reviewed 145 patients taken for planned re-laparotomy and compared APACHE II and MOD scores, complications, hemodynamic variables, outcomes, and demographics. The overall mortality rate for this study was 30%. Independent predictors of outcome were closure of the abdomen, complications, and APACHE II and MOD scores [6]. When closure of the abdomen was achieved, the mortality rate was 18%; however, for patients in whom the abdomen was not closable, the mortality rate was 100%. The authors concluded that patients with diffuse peritonitis are not a uniform group and that the decision when to close the abdomen may be based not only on intraperitoneal findings but also on the extent of organ dysfunction.

Hutchins et al. [7] also performed a retrospective review to examine clinical assessment and the factors that led to re-laparotomy. Of 1,482 patients in the intensive care unit (ICU) after abdominal surgery, 4.4% underwent re-laparotomy (it is unclear whether this was planned or on-demand). The median interval to re-laparotomy was five days. The authors noted a 43% mortality rate, 60% prevalence of MODS, and the presence of a surgically treatable cause in 83% of patients at re-laparotomy. Outcomes were dependent on age and the presence of MODS. There was no significant correlation with urgency of initial laparotomy, initial APACHE II score, time interval to re-laparotomy, or the number of re-laparotomies.

If we could recognize who was going into MODS and intervene, would outcomes improve? van Ruler et al. [8] in 2007 retrospectively reviewed 219 patients undergoing emergency laparotomy for secondary peritonitis to look for variables that would predict positive findings. Re-laparotomy was performed in 117 patients. Their data suggested both the initial cause for laparotomy and operative findings were poor predictors of repeat laparotomy. The predictors that were associated with a greater likelihood of re-laparotomy included younger age, decreased hemoglobin concentration, temperature > 39°C, lower PaO₂:FIO₂, higher heart rate, and elevated serum sodium concentration. However, the presence of these factors indicates progression to MOD, and the goal is to identify the patients before the development of MOD.

Lamme et al. [9] performed a meta-analysis of re-laparotomy for secondary peritonitis in 2002, including eight observational studies [5, 10 –16]. A total of 1,266 patients from the eight studies were included in the meta-analysis (286 planned laparotomy and 980 laparotomy on demand)[9]. Studies were noted to be heterogeneous from both a clinical and a statistical standpoint. The authors then calculated a combined odds ratio for in-hospital death using a random-effects approach to compensate for heterogeneity. The odds ratio was 0.70 (CI 0.27, 1.80) in favor of the on-demand strategy but without statistical significance.

Two additional studies published following this meta-analysis also directly compare planned vs. on-demand laparotomy, although with different conclusions. Rakic et al. [17] compared outcomes prospectively of 65 patients with severe peritonitis (APACHE II > 10) who were treated at two hospitals. Patients in one hospital (n = 34) were treated with the on-demand strategy, whereas the 31 patients in the other hospital underwent planned laparotomy. On initial analysis, the mortality rate was significantly higher in the on-demand group (59 vs. 29%; p = 0.0024). However, after adjustments for sex and APACHE II score, the difference in the mortality rate was no longer significant. Additionally, APACHE II score was found to be predictive of death with either surgical technique. The authors concluded that although planned laparotomy seemed to have lower mortality rate, there was no significant difference after adjustments and that disease severity, not surgical approach, has a larger role in patient survival.

Lamme et al [18] reached a different conclusion in 2004. They conducted a retrospective study of 278 patients with secondary peritonitis and compared the 81 treated with planned laparotomy and the 197 treated with on-demand laparotomy. In this study, the overall average APACHE II scores were lower than in the prior study (10.8 for on-demand and 11.7 for planned). The authors found a significantly lower hospital mortality rate for on-demand laparotomy (21.8% vs. 36%; p = 0.016) and a better two-year survival rate (65.8% vs. 55.5%; p = 0.031). In this study, treatment choice was an independent predictor of survival. In secondary outcomes, the ICU stay was longer for planned laparotomy patients, but mechanical ventilation days and total hospital stay were similar. More than one-half (54.8%) of the on-demand group did not undergo laparotomy. The APACHE II score was again found to correlate well with disease severity and survival. Interestingly, in patients undergoing laparotomy, there was no survival difference between planned and on-demand laparotomy. This suggests that some of the benefit of the on-demand strategy may have been in patients with lower APACHE II scores, as would be expected.

In 2007, van Ruler et al. [3] published the only randomized clinical trial comparing the strategies of planned and on-demand laparotomy. This was a multicenter study conducted in The Netherlands between 2001 and 2005. The inclusion criteria were diagnosis of secondary peritonitis (intra-abdominal infection verified by surgery caused by perforation, ischemia, or postoperative infection) and index laparotomy. Additionally, the patient needed an APACHE II score > 10 points in the initial 24 h. The exclusion criteria were extremes of age and infections with more defined management strategies (pancreatitis, endoscopy-related perforation, infection secondary to a dialysis catheter, malignant disease with expected survival of less than six months). Planned laparotomies were performed every 36–48 h until macroscopically negative. On-demand laparotomies were performed only in patients with clinical deterioration or lack of improvement. The primary outcome was death and major disease-related morbidity within 12 months. Secondary outcomes included health care utilization and cost. In total, 232 patients were randomized. Final data were available from 229 patients in the initial period and 225 at followup. Total numbers of re-laparotomies differed in the two groups with 113 in the on-demand group and 233 in the planned group (p < 0.001). In the on-demand group, 42% underwent re-laparotomy, which was negative 31% of the time. The planned group had a negative laparotomy rate of 66% (p < 0.001). Positive findings were comparable for the two strategies; 29% of the on-demand group and 32% of the planned laparotomy patients.

The primary outcomes of the study, death and major morbidity, were similar in the two groups at 12 months (mortality 29% on-demand and 36% planned; p = 0.23; morbidity 40% on-demand and 44% planned; p = 0.58) [3]. However, there were significant differences in the secondary outcomes, with the on-demand group having significantly shorter ICU stays (7 vs. 11 days), fewer hospital days (27 vs. 35), and lower cost (23% less). Although this study does not answer the question of which is a better strategy, it does suggest the on-demand strategy has benefits (less health care utilization and cost) and that mandatory laparotomy is not helpful unless indicated for specific purpose. Additionally, this study demonstrates that we still need to improve our ability to select patients who would benefit from re-operation. Overall, it appears that clinicians are still too quick to operate and hence thus have a high negative laparotomy rate (32% in the on-demand group) regardless of the strategy employed [19].

Conclusion

In summary, the main tenets of intra-abdominal sepsis remain early antibiotics, source control, and supportive care. There are two strategies still widely in use to achieve source control: Planned re-laparotomy and laparotomy on demand. The goal of planned re-laparotomy is to prevent ongoing sepsis and development of MODS; however, this strategy leads to a number of negative laparotomies and may not be associated with better outcomes. The goal in on-demand laparotomy is to identify which patients are at risk for persistent intra-abdominal sepsis and intervene before they develop MODS; however, this task has proved difficult. Two things are clear: (1) Development of MODS leads to a significantly higher mortality rate; and (2) clinical guidelines are needed to help identify patients at greater risk for treatable intra-abdominal sepsis to allow re-operation before the onset of MODS. Although in the past, planned laparotomy made sense for ensuring source control, improvements in imaging, intensive care therapy, and percutaneous interventions may have shifted the balance toward the laparotomy-on-demand strategy. Regardless of strategy, the rate of negative laparotomy remains high (>30%) [19]. Further work to develop more specific clinical tools and criteria to improve the accuracy of diagnosis may lead to the use of laparotomy on demand rather than planned laparotomy. At this time, however, there is no good clinical evidence to support one strategy over the other from a mortality standpoint.

Footnotes

Author Disclosure Statement

No conflicting financial interests exist.

Presented at the 29^th Annual Meeting of the Surgical Infection Society, Chicago, Illinois, May 6–9, 2009.

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