Abstract
Background:
The indications for damage-control laparotomy (DCL) in patients with intra-abdominal injuries have evolved from its use in trauma patients with hypothermia, coagulopathy, and acidosis to use in general surgical patients with acute intestinal perforations. Whereas some patients may be acidotic, most are not hypothermic or afflicted with coagulopathies. Recent study suggests the benefits to patients of rapid source-control laparotomy (RSCL) are not realized in patients with acute abdominal emergencies.
Methods:
Three years of data (2014–2016) from The American College of Surgeons National Surgical Quality Improvement Program (ACSNSQIP) were assessed. The patient populations were separated into RSCL patients who had their fascia left open after the initial source control operation and those who had primary fascial closure (PFC). The principal outcome of interest in this study was death within thirty days. A secondary analysis was performed evaluating complications and length of stay.
Results:
Of the 1,381 patients who qualified for the study, 396 (28.7%) were managed with RSCL and the remaining 985 patients had PFC. After a univariable analysis, propensity score matching was performed. The median hospital length of stay was 20 days (95% confidence interval [CI] 18–22) versus 14 (95% CI 13–16; p < 0.001) in RSCL and PFC, respectively. A larger number of patients having RSCL went to a rehabilitation facility than those having PFC (18.7%; versus 11.2%; p = 0.014). The 30-day mortality rate in patients in the RSCL group was significantly higher than in the PFC group ((32.6% versus 16.9%; p < 0.001).
Conclusion:
These data provide strong evidence that RSCL may not be beneficial for routine use in perforated colon surgery.
Rapid source-control laparotomy (RSCL) is a concept extending from the principles of damage-control laparotomy (DCL) first documented 80 years ago by Ogilvie [1]. The RSCL procedure was born from the trauma literature and reinvigorated by Stone et al. It was later supported by clinical evidence of a mortality benefit of DCL in patients with the lethal triad: Hypothermia, metabolic acidosis, and coagulopathy [2]. After initial operative management, a patient is brought to an intensive care setting for aggressive resuscitation followed by definitive closure within 48 hours if resuscitation is successful [3,4].
Rapid source-control laparotomy utilizes the concepts of DCL and applies them to intra-abdominal sources of infection rather than to a traumatic insult. There is some evidence that its use is valuable in managing necrotizing pancreatitis [5] and complicated diverticulitis [6]. However, general guidelines and indications for its effective use are ill defined. In 2016, Becher et al. attempted to define the indications for the RSCL approach and displayed some evidence of benefit when utilized under the following circumstances: Severe sepsis or septic shock, an elevated serum lactate concentration ≥3 mg/dL, acidosis (pH <7.25), elderly patient (>70), male gender, or three or more associated co-morbidities [7].
A recent study addressed the merits of RSCL for a variety of acute surgical crises strictly from the standpoint of a mortality benefit [8]. This analysis examined a wide array of intra-abdominal operations, including upper gastrointestinal, mid-gut, and large-bowel emergencies. Becher et al. determined that this approach is associated with a higher chance of death than for those patients undergoing primary facial closure (PFC) [7]. We focused retrospectively on patients with colonic perforations with the intent of determining if RSCL in non-traumatic, general surgical emergencies, has the benefits documented in trauma surgery. We wanted to determine if there was an outcome difference in patients treated with RSCL versus conventional management with fascial closure.
Patients and Methods
This retrospective cohort analysis was based on three years of data, from 2014 through 2016, compiled from The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP). The data were used to assess patients who had emergency colectomy for perforation. The different diagnoses are shown in Table 1. The patient populations were separated into two groups: Group 1, patients who had their fascia left open after the initial operation, and Group 2, patients who had their fascia closed primarily (PFC) after initial operation and the skin left open.
Diagnoses of 1,381 Patients with Intestinal Perforation
ICD = International Classification of Diseases.
Univariable analysis was performed on the baseline patient characteristics including age, sex, and American Society of Anesthesiologists (ASA) class. This was followed by propensity score-matching analysis. Paired matched analysis was performed for death, infection, ventilator days, transfusion rate, and septic shock. The primary outcome of the study was death within 30 days using paired matched analysis with secondary analyses of the rates of complications. Post-operative primary outcomes included length of stay and days until discharge to home or to a rehabilitation facility. Post-operative secondary outcomes included failure to wean, acute renal failure, transfusion requirements, systemic sepsis, and septic shock.
Statistical significance was considered if the p value was <0.05.
Results
The cohort consisted of 1,381 patients. Of these, 396 (28.7%) patients were managed with RSCL and the others had primary fascial closure (PFC). Table 2 shows the 30-day deaths and length of stay in the two groups before matching. Mortality rate, length of stay, and day of death were significantly different in the two groups. Table 3 shows the discharge destination of the two groups before matching. Table 4 shows the results from unadjusted analysis. The patients having RSCL differed by superficial infection, principal procedure, ventilatory support, diabetes mellitus, ascites, dialysis, weight loss, history of congestive heart failure, transfusion, ASA class, and presence of septic shock. Race, smoking history, history of chronic obstructive pulmonary disease (COPD), renal failure, history of cancer, steroid use, and wound classification did not differ between the groups.
Before Matching: 30 Day Mortality Rate and Length of Stay
CI = confidence interval; PFC = primary fascial closure; Q = quartile; RSCL = rapid source-control laparotomy; SD = standard deviation.
Before Matching: Discharge Destination
Q = quartile; SD = standard deviation.
Before Matching: Demographics
ASA = American Society of Anesthesiologists; COPD = chronic obstructive pulmonary disease; SD = standard deviation.
After propensity matching, the significant differences are shown in Table 5. Surgical site infections (SSIs) were more than seven times more common in the RSCL group than in the PFC group (2.2% versus 0.3%; p < 0.049). Length of stay was significantly longer in the RSCL than in the PFC group (median 20 [95% CI 18–22] days versus 14 [95% CI 13–16] days; p < 0.001), respectively. A larger number of patients in the RSCL group than in the PFC group went to a rehabilitation facility (18.7% versus 11.2%), whereas the patients in the PFC group were more likely to return home after hospital discharge (44.4% versus 33.7%).
Significant Differences After Propensity Matching
PFC = primary fascial closure; RSCL = rapid source-control laparotomy.
There were more than twice as many patients on ventilator support for more than 48 hours in the RSCL group than in the PFC group (62.5% versus 25.5%; p < 00001). The rate requiring transfusions was higher in patients with open than closed abdomens (41.3% versus 33.4%; p < 0.05). The mortality rate was almost twice as high in the RSCL group than in the PFC group, 129 patients (32.6%) versus 67 patients (16.9%); p < 0.001.
Prior to matching in the presence of septic shock, 46.2% of the RSCL group were affected compared with 18.2% of the PFC group. After matching, the rate of septic shock was 44.2% vs 30.4%. In both conditions, the rate of septic shock was significantly higher in the RSCL than in the PFC group (p < 0.001). Although the matching corrected this difference to some degree, the correction was limited.
Discussion
The RSCL approach for non-trauma abdominal pathology has become an increasingly controversial topic, with some advocating open abdomen [9,10] and others arguing against this technique as routine practice [7,8]. In our study, more than 25% of patients were managed without fascial closure. We believe this is a remarkably high rate, especially given the limited data that support its use. In addition, there as not a standard method or duration of temporary closure. In trauma patients with the lethal triad (hypothermia, coagulopathy, and acidosis), aborting an operative procedure by covering the abdomen to correct the metabolic aberrations may be life-saving. It is difficult, however, to imagine such a large percentage of this patient population would meet the standard criteria for RSCL. Because only 44.2% of the patients in the RSCL group were in septic shock at the time of surgery, 181 patients did not meet the criteria for RSCL. Consequently, those patients were managed with an open abdomen for reasons other than the presence of the lethal triad. One reason would be to avoid an abdominal compartment syndrome. A second motive for justifying RSCL is to re-establish intestinal continuity by serial abdominal washouts in the operating room; in other words, performing a staged procedure to re-establish intestinal continuity. The efficacy of a primary anastomosis in this setting has not been evaluated. One study [10] documented superior outcomes of DCL over PFC in trauma patients. However, the mean age of the patients was 29 years old, which is more than 30 years younger than the mean age of the patients in our study.
A recent publication by Kirkpatrick et al. reviewed the published data regarding RSCL extensively [11]. As those authors point out, many studies mix trauma patients with non-trauma acute care patients, which also mixes age and disease types, making it difficult to draw firm conclusions. For example, patients with acute perforating diverticulitis have a different bacterial milieu in their peritoneal cavity than those with a penetrating bowel injury [12]. A randomized trial to evaluate RSCL in non-trauma patients would provide much information as to where and when this technique should be used.
A putative advantage of RSCL is the control of sepsis. However, in this study, a greater risk of SSI was seen in the RSCL than the PFC group. Additionally, it is presumed that repeated washouts of the abdominal cavity after source control reduce the bacterial load to the site. This did not occur to the degree that the infection rate was reduced. The negative impact of leaving the peritoneal cavity open to the environment needs to be considered as a risk factor for the patients' homeostasis. There has not been any organized assessment of the immune consequences of leaving the abdomen open with a closed drainage system [11]. Not only do the liquid mediators, such as complement and immunoglobulins, leak out through the peritoneal cavity, but the peritoneal surface, a dialyzable membrane, may be exposed to and stimulated by endotoxin [13]. The continued stimulation of the peritoneal surface also may result in neutrophil diapedesis [14]. The delay in restoring homeostasis by closing the peritoneal cavity may differ from surgeon to surgeon from a 24-hour delay to several days. Unfortunately, these individual management concerns cannot be addressed with this database.
The greater ventilator time required for the RSCL patients may impact the length of stay and discharge disposition significantly, but this idea has not been addressed in prior studies. The prolonged ventilatory support results in extended bed rest and the use of paralytics and narcotic sedation, rapidly deconditions patients. The fact that the mean age of the patients in our study was 62 years and that the elderly population is prone to rapid deconditioning is a significant concern [15]. The benefits of early mobilization in this elderly population have been documented with the many enhanced recovery after surgery (ERAS) bundles, which have expedited hospital discharge. Absence of these two factors may have contributed to the prolonged length of stay and higher likelihood of needing rehabilitation facilities after discharge.
The mortality rate was much higher in the RSCL group than in the PFC group, which is consistent with the two prior studies and with our hypothesis [7,8]. This current study, which limited the participants to patients with colon perforations, had a high mortality rate in the RSCL group (31.4%), which is surprisingly similar to the rate in a prior study (32.6%) [8]. The mortality rate in the PFC group was lower in this current study (16.9%) than in the prior study (21.4%). The prior study included a wider cross-section of diagnoses such as gastrointestinal bleeding and severe pancreatitis, which probably impacted the mortality rate for their PFC group.
A weakness of this paper is that before matching, patients treated with RSCL were statistically more likely than PFC patients to be in septic shock (see Table 4) (46.2% versus 18.2%, respectively; p < 00001). After matching (Table 5), the numbers changed slightly, but the difference remained statistically significant (44.2% [RSCL] versus 30.4% [PFC]; p < 00001). A comparison of patients in septic shock treated with RCCL and PFC has been done [16]. A higher mortality rate was seen in the RSCL group (35.7%) than in the PFC group (28.5%), but this difference was not statistically significant. The investigators in the earlier study concluded that there was no significant advantage or disadvantage to RSCL [16]. Such an analysis should be repeated to confirm the earlier findings. These data need to be analyzed carefully to determine whether there is a subset of patients with perforated colon in septic shock who do obtain a significant benefit from RSCL. As mentioned above, these data are limited by the variability among surgeons in the temporary abdominal covering and the interval between the initial source control procedure and definitive abdominal closure.
In conclusion, this study shows that statistically significant morbid and mortal consequences result from RSCL compared with PFC. The limiting factors of the study are: (1) The lack of control for the method and duration of the temporary abdominal visceral covering for the open abdomen group; (2) the application of standard criteria for the use of RSCL; and (3) the performance of enteric anastomoses at the time of surgery in the RSCL group. Because more than half of the patients who had RSCL were not in septic shock, specific criteria need to be established for RSCL. More controlled prospective analysis needs to be done to determine how RSCL best fits for patients with non-traumatic large colon perforations.
Footnotes
Author Disclosure Statement
No competing financial interests exist.
