Rapid Source-Control Laparotomy: Is There a Mortality Benefit in Septic Shock?

Abstract

Background:

In the 1990s, damage control laparotomy (DCL) became a proved approach to treat intra-abdominal injuries caused by trauma. In the ensuing two decades, this approach has been applied to non-traumatic abdominal processes as well. Although the benefits of DCL are clear, the benefit of rapid source-control laparotomy (RSCL) for non-traumatic abdominal diseases is much less clear. However, two recent cohort analyses identified significant increases in the mortality rate with RCSL compared with primary fascial closure (PFC). The purpose of this study was to assess the efficacy of RSCL in patients with septic shock.

Methods:

The 2015 National Surgical Quality Improvement Project (NSQIP) database was queried for 11 International Statistical Classifications of Diseases (ICD)-10 codes associated with septic shock. Collected data included age, gender, body mass index (BMI), wound class, American Society of Anesthesiologists (ASA) class, operative time, number of risk factors, and presence or absence of post-operative pneumonia. The risk factors were diabetes mellitus, alcohol or tobacco abuse, blood dyscrasias, disseminated cancer, and cardiac, gastrointestinal, pulmonary, hepatobiliary, or renal dysfunction. The primary outcomes were rate of re-operation, prevalence of post-operative pneumonia, hospital length of stay (LOS), and death by 30 days.

Results:

The RSCL and PFC cohorts were each comprised of 56 patients matched for propensity scores for ICD-10 code. There were no significant differences in wound or ASA class, BMI, gender, or number of risk factors between the two cohorts. The operative time for RSCL was significantly shorter than for PFC (median 84 vs. 128 min, respectively; p = 0.002). There was no significant difference in re-operation rate, prevalence of post-operative pneumonia, LOS, or mortality rate between the two cohorts.

Conclusions:

Although this analysis showed no clear advantage to RSCL in the management of septic shock, it may be a means to salvage certain patients. The best way to assess the relative value of RSCL is a prospective trial.

Rapid source-control laparotomy (RSCL) was first described by Ogilvie in 1945 as a method of treating intra-abdominal contamination. The initial report described source control, placement of a Vaseline-impregnated canvas, and planned return in 1–4 d for definitive closure [1]. The RSCL technique originated as an extension of damage-control laparotomy, first described by the same surgeon in 1940 [2]. This report reviewed control of hemorrhagic shock in trauma patients and placement of a temporary abdominal closure device. This is followed by aggressive resuscitation in the intensive care unit and correction of the physiologic abnormalities associated with hemorrhagic shock: Metabolic acidosis, coagulopathy, and hypothermia [3,4]. This technique has demonstrated a mortality benefit in patients with either blunt or penetrating abdominal trauma [5]. It is debated whether expeditious source control with placement of a temporizing closure device demonstrates a morbidity and mortality benefit over primary fascial closure (PFC) in intra-abdominal sepsis. The current body of evidence suggests complicated diverticulitis [6] is the only state of intra-abdominal sepsis in which patients benefit from RSCL and staged closure [7].

The concern about the current literature is in its analysis of all patients with intra-abdominal sepsis. It thus misrepresents the appropriate cohort for RSCL. In intra-abdominal sepsis, the physiological derangements of metabolic acidosis, coagulopathy, and hypothermia do not present until severe organ dysfunction and distributive shock arise. Only one study, a retrospective cohort analysis of 24 patients, addresses the morbidity and mortality benefit RSCL may provide under these physiologic conditions. There was no statistically significant difference in the 30-day mortality rate in this subgroup analysis. However, a larger sample is needed to gain a more precise estimate of the effect RSCL has on the 30-day mortality rate [8].

The purpose of this study was to determine the influence RSCL has on the mortality rate, hospital length of stay (LOS), and unplanned re-operations in non-trauma patients with intra-abdominal septic shock. The hypotheses were that RSCL reduces the 30-day mortality rate, hospital LOS, and number of unplanned re-operations compared with PFC.

Patients and Methods

Patient selection criteria

This was a retrospective cohort analysis based on the 2015 National Surgery Quality Improvement Program (NSQIP) database. The inclusion criteria were septic shock in patients who underwent RSCL or PFC for the International Statistical Classifications of Diseases (ICD)-10 codes listed in Table 1. The sole exclusion criterion was an incision classification of clean.

Table 1.

Indications for Intervention in Rapid Source-Control Laparotomy and Primary Fascial Closure

ICD-10 code	Diagnosis	Both cohorts (%)
A41.90	Sepsis	22 (39.3)
K25.10	Acute gastric ulcer perforation	2 (3.6)
K55.10	Chronic vascular disorder of intestine	1 (1.8)
K55.90	Vascular disorder of intestine, not specified	5 (8.9)
K56.60	Intestinal obstruction not specified	1
K56.69	Ileus with obstruction	1
K57.20	Diverticulitis of large intestine with perforation or abscess	3 (5.4)
K57.80	Diverticulitis of intestine with perforation or abscess	2 (3.6)
K63.10	Non-traumatic perforation of intestine	17 (30.4)
K65.10	Peritoneal abscess	1
K65.90	Peritonitis, not specified	1

Collected data included age (binary variable: <65 vs. ≥65 y), gender, body mass index (BMI), incision classification (binary variable: Clean/contaminated vs. contaminated or dirty/infected), American Society of Anesthesiologists (ASA) classification (binary variable: 0–2 vs. 3⁺), operative time, number or risk factors (binary variable: <4 vs. ≥4), and post-operative pneumonia. The risk factors were diabetes mellitus, alcohol or tobacco abuse, blood dyscrasias, disseminated cancer, or cardiac, gastrointestinal, pulmonary, hepatobiliary, or renal dysfunction. The primary outcomes were the rate of unplanned re-operation, prevalence of post-operative pneumonia, hospital LOS, and death before 30 days. Given the influence of indications for intervention on study outcomes (i.e., death, LOS, post-operative pneumonia), RSCL patients were matched to PFC patients based on propensity scores for ICD-10 code.

Statistics

All statistical analyses were conducted using the Statistica software package Version 13 (Dell Inc., Round Rock, TX 1984–2015) and R (The R Foundation for Statistical Computing, Vienna, Austria 2015). Baseline patient demographic characteristics, incision class type, ASA class, operative time, and number of risk factors were compared for the RSCL and PFC groups using Mann Whitney U, Fisher exact, or Pearson χ² test, depending on variable classification. Similar bivariable analyses were conducted to evaluate associations between incision closure type and hospital LOS, 30-day mortality rate, post-operative pneumonia, and re-operation. For hospital LOS, first-quartile data were excluded to mitigate the influence of non-survivable states of intra-abdominal infection on LOS. Statistical significance was evaluated using α = 0.05.

Results

Rate of open abdomen and septic shock in non-trauma patients

The following ICD-10 codes were used to identify patients who had open abdomens: A41.90, K25.10, K43.00, K43.60, K55.10, K55.90, K56.20, K56.50, K56.60, K56.69, K57.20, K57.80, K63.10, K65.10, and K65.90. All of these operations were emergencies. A total of 2,627 patients met these criteria of whom 219 (8.34%) had open abdomens and 2,408 had PFC. Of the 219 patients, only 25.57% met the NSQIP criteria for septic shock. These criteria are listed in the American College of Surgeons NSQIP Operations Manual (pp. 65–66). There were 56 patients in this cohort. These patients were propensity score-matched with patients having PFC for analysis.

Diagnostic codes

The ICD-10 codes and indications for intervention are listed in Table 1. The most common indications for intervention in both cohorts were sepsis (39%), non-traumatic intestinal perforation (30%), and vascular disorder of intestine, not specified (9%).

General demographics

There were no significant differences in age (p = 0.26), male:female ratio (p = 0.71), BMI (p = 0.83), or number of risk factors (p = 0.09) between the RSCL and PFC cohorts.

Operative risk

There were no significant differences in incision class type (p = 0.36) or ASA class (p = 0.50) between the RSCL and PFC cohorts (Table 2). Consistent with the principle of rapid source control, the median operative time was 84 vs. 128 min (p = 0.002). These results are shown in Table 3.

Table 2.

Baseline Patient Characteristics in Rapid Source-Control Laparotomy (RSCL) and Primary Fascial Closure (PFC) Cohorts

	RSCL cohort	PFC cohort	Statistical significance
Number of patients	56	56
Age (y) (%)			p = 0.26^a
<65	32 (57.14)^a	26 (46.43)^b	OR 0.65
≥65	24 (42.86) ^a	30 (53.57) ^b	(CI 0.31–1.37)
M:F (%)	30:26	28:28	p = 0.71
	(53.6:46.4)	(50.0:50.0)	OR 0.87
			(CI 0.41–1.82)
BMI^b	N = 25	N = 26	p = 0.83^c
	21.18	20.85
	(IQR 10.79–33.47)	(IQR 14.20–27.02)
Number of risk factors (%)			p = 0.09
0–3	24 (42.86)	33 (58.93)	OR 1.91
4+	32 (57.14)	23 (41.07)	(CI 0.90–4.05)

Calculated using Pearson χ² test.

Expressed as median (interquartile range).

Calculated using Mann-Whitney U test.

CI = confidence interval; OR = odds ratio.

Table 3.

Operative Risk in Rapid Source-Control Laparotomy (RSCL) vs. Primary Fascial Closure (PFC) Cohorts

	RSCL cohort	PFC cohort	Statistical significance
Incision class (%)			p = 0.36^a
Clean/contaminated or contaminated	3 (5.4)	5 (8.9)	OR 1.73
Dirty/infected	53 (94.6)	51 (91.1)	(CI 0.39–7.62)
ASA class (%)			p = 0.50^b
1–2	14 (25.0)	11 (19.6)	OR 0.73
3⁺	42 (75.0)	45 (80.4)	(CI 0.30–1.79)
Operative time^c	84.00	128.00	p = 0.002^d
	(IQR 58.0–128.5)	(IQR 84.0-165.5)

Calculated using Fisher exact test.

Calculated using Pearson χ² test.

Median (interquartile range); operative time in min.

Calculated using Mann-Whitney U test.

ASA = American Society of Anesthesiologists; CI = confidence interval; IQR = interquartile range; OR = odds ratio.

Rate of re-operation outcome

Propensity score analysis adjusting for ICD-10 code and number or risk factors demonstrated no significant difference between the rates of unplanned first re-operation in the RSCL and PFC cohorts (19.6 vs.12.5%; p = 0.30). These results are tabulated in Table 4.

Table 4.

Outcomes in Rapid Source-Control Laparotomy (RSCL) vs. Primary Fascial Closure (PFC) Cohorts

	RSCL cohort	PFC cohort	Statistical significance
Mortality outcome (%)			p = 0.42^a
Alive	36 (64.2)	40 (71.4)	OR 1.39
Dead	20 (35.7)	16 (28.5)	(CI 0.63–3.08)
Length of stay^b	19.5	17.0	p = 0.92^c
	(IQR 11.5–29.5)	(IQR: 13.0–29.5)
Pneumonia (%)			p = 0.65^a
No	42 (75.0)	44 (78.6)	OR 1.22
Yes	14 (25.0)	12 (21.4)	(CI 0.51–2.94)
Reoperation (%)			p = 0.22^d
No	45 (80.4)	49 (87.5)	OR 1.71
Yes	11 (19.6)	7 (12.5)	(CI 0.61–4.79)

Calculated using Pearson χ² test.

Median (interquartile range) hospital stay in days.

Calculated using Mann-Whitney U test.

Calculated using Fisher exact test.

CI = confidence interval; OR = odds ratio.

Post-operative pneumonia outcome

Propensity score analysis adjusting for ICD-10 code and number or risk factors demonstrated no significant difference in post-operative pneumonia between the RSCL and PFC cohorts (25.0 vs. 21.5%; p = 0.65). These results also are tabulated in Table 4.

Hospital LOS outcome

Hospital LOS outcome was analyzed using propensity score analysis adjusted for ICD-10 code and number or risk factors. There was no significant difference in adjusted LOS between the RSCL and PFC cohorts (19.5 vs. 17 days; p = 0.92) (Table 4).

Mortality rate outcome

Propensity score analysis adjusted for ICD-10 code and number of risk factors demonstrated no significant difference in the mortality rate in the RSCL and PFC cohorts (35.7 vs. 28.6; p = 0.42) (Table 4).

Discussion

Four studies in the Western literature examine the influence of RSCL and PFC on 30-day mortality rates in septic patients undergoing general surgery [7-10]. All studies fail to demonstrate a reduction in the mortality rate with the RSCL technique. The largest of these, a retrospective examination described herein, demonstrated that the odds of death within 30 days with RSCL is 1.78 times that of PFC in patients with intra-abdominal sepsis. However, these data fail to account for physiologic differences between sepsis and septic shock and overlook critically ill patients with intra-abdominal septic shock whose metabolic derangements mimic the lethal triad for which damage control laparotomy was devised.

Septic shock is a hypercoagulable state secondary to release of pro-inflammatory cytokines, activation of the extrinsic cascade through tissue factor, inhibition of fibrinolysis through the protein C/S cascade, and consumption of anti-thrombin [11]. The result is metabolic acidosis secondary to microthrombus formation, infarction, and tissue hypoxia. Myocardial depression, mediated by bacterial endotoxin and cytokine release, creates both systolic and diastolic dysfunction, compromises end-organ perfusion, and further alters the physiologic milieu [12]. These hemodynamic changes mandate massive resuscitation with crystalloid product to maintain circulatory volume and promote dilutional coagulopathy.

The results of this retrospective study demonstrated RSCL, in propensity matched analysis, did not result in a significant difference in the rate of unplanned re-operation, prevalence of post-operative pneumonia, hospital LOS, or death within 30 days. The underlying reason for the lack of a statistically significant difference between the RSCL and PFC cohorts with regard to hospital LOS (19.5 vs. 17 days; p = 0.92) is unclear. The median difference of one and one-half days is presumably attributable to a prolonged ventilator requirement secondary to open abdomen. A larger sample may yield a more precise estimate of the effect RSCL on LOS.

There is one study in the Western literature that included a subgroup analysis of 24 patients with septic shock who underwent RSCL or PFC. In this study, Becher et al. [8] failed to demonstrate a mortality benefit for RSCL over PFC (54 vs. 60%, respectively; p = 0.69). The authors state that the indication for RSCL is ease of re-operation, as 50% of patients with PFC required an unplanned re-operation. In this study of a total of 56 patients, the rate of unplanned re-operation was 19.6% vs. 12.5% (p = 0.22) in the RSCL and PFC cohorts, respectively. It is unclear what factors contributed to the difference in the rate of unplanned re-operation. The lack of a significant difference in unplanned re-operations in this larger study suggests that septic shock is not an appropriate indication for RSCL. However, this study is limited in its analysis of 30-day re-operation rate. Moreover, the data fail to account for long-term complications of RSCL, including ventral hernia and enteroatmospheric fistula, that demand a significantly higher future re-operation rate for the RSCL cohort [13].

The limitations of this study are that, first, NSQIP lacks the pre-operative physiological data necessary to determine whether trauma indications (pH <7.25, coagulopathy, and hypothermia) are present. Also, the sample is small, although in an analysis of a larger unmatched dataset, the same results were found. There is a need for future studies to examine the relation between these variables, death, and LOS in patients with intra-abdominal septic shock. There is also a need for prospective trials, documenting physiologic parameters of the lethal triad, to demonstrate whether RSCL is an appropriate management technique for intra-abdominal septic shock.

Footnotes

Author Disclosure Statement

No competing financial interests exist for any of the authors.

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