ANNSURG-D-15-01413
ORIGINAL ARTICLE
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Data File (PUF) for 2012 and 2013. Cases that were emergent or Mean patient age was 61.1 years, 9478 (48.1%) were male,
nonelective were excluded, as were cases with missing data for type and 41.9% of the cases were performed for the diagnosis of colon
of preoperative bowel preparation or for covariates included in the cancer (Table 1). Of note, 5060 (25.7%) patients did not receive any
final multivariable model. form of bowel preparation, 8020 (40.7%) received MBP only, 641
The primary outcomes of interest were wound dehiscence, (3.3%) received OABP only, and 5965 (30.3%) received combination
anastomotic leak, pneumonia, prolonged (>48 h) ventilation, urinary MBP plus OABP. Comparing the baseline characteristics across the
tract infection (UTI), systemic sepsis, septic shock, deep vein different types of bowel preparation method (Table 2), there was no
thrombosis (DVT), pulmonary embolism (PE), LOS, unplanned
readmission, unplanned reoperation, and mortality. All outcomes
occurring within 30 days of surgery were reported in the NSQIP
database. TABLE 1. Study Population Characteristics (n 19,686)
The primary independent variable of interest was the type of
preoperative bowel preparation administered. The Colectomy Age (mean), yrs 61.15
Targeted NSQIP includes data on both MBP and OABP. Patients Sex (%)
Male 9478 (48.15)
were divided into 4 groups: (1) no preoperative preparation, (2) MBP Female 10,208 (51.85)
only, (3) OABP only, and (4) MBP plus OABP. Other independent Race
variables of interest included age, sex, race, American Society of White 14,965 (76.02)
Anesthesiologists (ASA) class, smoking status, diabetes, history of African American 1504 (7.64)
congestive heart failure, history of chronic obstructive pulmonary Hispanic 2210 (11.23)
disease, body mass index (BMI), weight loss, indication for surgery, Other/unknown 1007 (5.12)
surgical approach (laparoscopic vs open), type of procedure, and ASA classification (%)
operative time. These variables were chosen based upon clinical ASA 2 10,591 (53.80)
grounds and findings from previous analyses of colectomy outcomes. ASA 3 8465 (43.00)
ASA 4 630 (3.20)
SSI within 30 days of surgery was also included as an independent BMI
variable, as it was hypothesized to be on the causal pathway between <18.5 441 (2.24)
preoperative bowel preparation and the outcomes in this study, 18.524.9 5741 (29.16)
based both on previous studies demonstrating the association 25.029.9 10,804 (54.88)
between preoperative bowel preparation and SSI911 and the associ- 30.0 2700 (13.72)
ation between SSI and other poor postsurgical outcomes.14,15 SSIs >10% weight loss in the last 6 mo (%) 713 (3.62)
were categorized a superficial, deep, or organ space. In addition, a Current smoker (%) 3277 (16.65)
composite dichotomous variable was created which was yes if the Diabetes mellitus (%) 2767 (14.06)
patient had any of the 3 types of SSI, and no if there was no SSI. Hypertension (%) 9282 (47.15)
History of CHF (%) 95 (0.48)
Patient characteristics across the 4 preoperative bowel prep- History of COPD (%) 848 (4.31)
aration groups were analyzed using frequencies for categorical Ascites (%) 61 (0.31)
variables and medians and interquartile ranges for continuous vari- On hemodialysis (%) 76 (0.39)
ables. Chi-square tests and Kruskal-Walli tests were used to test for On steroid use for chronic conditions (%) 1503 (7.63)
differences between the 4 groups. Chi-square tests and Wilcoxon Received >4 units blood transfusion in 155 (0.79)
rank-sum tests were used to test for associations between SSI and 72 h before surgery (%)
other outcomes. Logistic regression was used to fit a multivariable Indication for surgery (%)
model of the relationship between binary outcomes and type of Colon cancer 8252 (41.92)
preoperative bowel preparation, adjusting for other covariates. Sim- Ulcerative colitis 350 (1.78)
Crohn disease 1197 (6.08)
ilarly, negative binomial regression was used to model the relation- Diverticular disease 4565 (23.19)
ship between LOS and type of preoperative bowel preparation. For Other 5322 (27.03)
each outcome, 4 models were fit: (1) type of preoperative bowel Bowel preparation (%)
preparation only, (2) type of preoperative bowel preparation plus SSI, None 5060 (25.70)
(3) type of preoperative bowel preparation plus all covariates except MBP only 8020 (40.74)
for SSI, and (4) model 3 plus any SSI. Model 1 was compared with OABP only 641 (3.26)
model 2, whereas model 3 was compared with model 4. If the P value MBP and OABP 5965 (30.30)
for preoperative bowel preparation went from significant (P < 0.05) Approach
to nonsignificant (P > 0.05) between the 2 models, we concluded that Open 7389 (37.53)
Laparoscopic 12,297 (62.47)
SSI could be on the causal pathway between preoperative bowel Procedure
preparation and that outcome. Ileocolic resection 4284 (21.76)
All analyses were performed using Stata 12.1 (StataCorp, Partial colectomy 8444 (42.89)
College Station, TX). Total colectomy 888 (4.51)
Hartmann/LAR 6070 (30.83)
Stoma
RESULTS Yes 2126 (10.80)
A total of 38,486 colectomy cases were identified in the No 17,560 (89.20)
NSQIP Colectomy Targeted PUF. Of these 11,784 were excluded Operative time
<3 h 11,474 (58.30)
because the cases were emergent or nonelective. An additional 6886 35 h 6231 (31.66)
cases were excluded because they were missing information on >5 h 1977 (10.04)
preoperative bowel preparation, and 130 cases were excluded
because of missing data in the multivariable regression covariates, CHF indicates congestive heart failure, COPD, chronic obstructive pulmonary
disease.
resulting in a study cohort of 19,686 cases.
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Annals of Surgery Volume XX, Number X, Month 2015 Benefits of Bowel Preparation
difference in sex distribution among the 4 groups; patients with ASA preparation (P < 0.001). Among patients who underwent laparo-
classification 1 to 3 were more likely to have received MBP only vs scopic surgery, 42.1% received MBP only, 31.3% received MBP plus
patients with ASA classification 4 to 5, and patients with a lower OABP, whereas 23.3% did not receive any bowel preparation.
BMI were more likely to have received no bowel preparation On univariable analysis comparing postoperative outcomes
compared with patients who had a higher BMI. Bowel preparation based on the type of bowel preparation, several factors were associ-
did vary by surgical indication. For example, 42.9% of patients with ated with improved outcomes (Table 3). Specifically, better outcomes
colon cancer and 43.11% of patients with diverticular disease in superficial SSI, deep SSI, organ space SSI, any SSI, anastomotic
received MBP only, whereas 38.6% of patients with ulcerative colitis leak, postoperative ileus, sepsis, readmission, and reoperation
and 35.4% of patients with Crohn disease did not receive any bowel were noted among patients who received MBP plus OABP vs no
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preparation, MBP only, or OABP only (all P < 0.05). In most cases, ventilation and septic shock, both of which had P value just above
MBP plus OABP was better than OABP only, which was better than 0.05 (P 0.061 and P 0.11, respectively). As noted above, both of
MBP only, and all types of bowel preparation were better than no these outcomes had the weakest association with preoperative bowel
bowel preparation. Outcomes not associated with bowel preparation preparation in model 1 (both P 0.008).
included wound dehiscence, UTI, DVT, and PE. Based on these Finally, in model 4, similar to the pattern observed between
results and data from previous studies,9 11 subsequent analyses model 1 and model 2, after adding SSI to model 3, only ileus, death,
were focused on the comparison between MBP plus OABP vs no and LOS remained associated with preoperative bowel preparation
preoperative bowel preparation. and all of the other outcomes were no longer associated with
Using univariable analysis to examine the relationship preoperative bowel preparation. The increases in the ORs for these
between SSIs and postoperative outcomes, occurrence of superficial outcomes ranged from 24% to 76%. Pneumonia was the only out-
SSI was associated with worse overall outcomes except for failure come that showed a different pattern from the previous models.
to wean from mechanical ventilator, PE, and mortality. A similar Between models 1 and 2, the association between pneumonia and
association was noted with the occurrence of deep SSI, which was preoperative bowel preparation went from highly significant to
associated with worse outcomes except for DVT and mortality. In marginally significant (P 0.001 to P 0.038), whereas between
addition, occurrence of organ space SSI and any SSI was associated models 3 and 4, the association went from marginally significant to
with poor outcomes (Table 4). Based on these results, we then not significant (P 0.048 to P 0.31).
analyzed SSI as a composite variable (ie, superficial, deep, organ
space). Missing Data
Table 5 shows the results of the 4 models that were fit in Of the 6886 patients excluded from this study because of
this study. These models are summarized below. In model 1, the missing information on preoperative bowel preparation, 1720 were
univariable association between preoperative bowel preparation and only missing information on MBP, 1550 were only missing infor-
each outcome was assessed. The use of MBP plus OABP was mation on antibiotic use, and 3616 were missing both. To assess the
associated with a marked reduction in all adverse outcomes except possible bias associated with missing data, we repeated the analysis
for UTI, DVT, and PE. In most cases, these associations were highly twice: (1) assuming that patients with missing bowel preparation data
significant (P < 0.001), with the exception of wound dehiscence did not have that type of bowel preparation, and (2) assuming that
(P 0.049), prolonged ventilation (P 0.008), and septic shock patients with missing data did have that type of bowel preparation.
(P 0.008). The results based on this imputation were very similar to the main
In model 2, when the composite SSI variable was added to results, both with respect to the relationship between preoperative
model 1, the use of preoperative bowel preparation was no longer bowel preparation and each of the outcomes, and the relationship
associated with wound dehiscence, anastomotic leak, prolonged between SSI and each of the outcomes. The multivariable models
ventilation, systemic sepsis, septic shock, unplanned readmission, based on imputation differed in a number of ways from the corre-
and unplanned reoperation. In addition, the increase in the ORs for sponding results in Table 5; however, when comparing model 2 to
these outcomes ranged from 37% to 146%. Only ileus, pneumonia, model 1 and model 4 to model 3, the imputed results consistently
death, and LOS remained associated with preoperative bowel prep- showed a lowering of significance when adding SSI to the model,
aration after adding SSI to the model. Although pneumonia was still consistent with the main results.
associated with preoperative bowel preparation, the association was
much weaker than in model 1 (P 0.038 vs P < 0.001). Subgroup Analysis
In model 3, most of the outcomes that were associated with Based on the results from Table 2, which show a wide variety
preoperative bowel preparation in model 1 remained so after the of practices surrounding preoperative bowel preparation by indica-
addition of other covariates, with the exception of prolonged tion for surgery, procedure type, and surgical approach (open or
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Annals of Surgery Volume XX, Number X, Month 2015 Benefits of Bowel Preparation
<0.001
0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
P laparoscopic), we performed a series of subgroup analyses to deter-
mine whether the main results were consistent across the different
subgroups. First, the association between the use of MBP plus OABP
and reduction in SSI was present for all indications for surgery
(10.08)
(0.43)
(0.77)
(1.03)
(0.60)
(1.96)
(0.90)
(0.41)
(0.82)
(0.44)
(6.59)
401 (2.27)
110 (0.62)
5.52 (4.14)
(all P < 0.05) and for both open and laparoscopic approaches (all
No
Any SSI
P < 0.001). This association was also present for all procedure types
76
73
78
1776
1162
135
181
106
345
159
144
except for total colectomy (P < 0.001 and P 0.12, respectively).
N (%)
(18.41)
(32.76)
447 (21.89)
(3.43)
(4.51)
(4.46)
(6.27)
(6.90)
(2.55)
(1.18)
27 (1.32)
10.37 (9.85)
subgroups and most outcomes and P < 0.05 for all outcomes and
subgroups except for pneumonia among patients with total colec-
Yes
tomy (P 0.23).
530
560
128
376
141
669
70
92
91
52
24
The association between preoperative bowel preparation and
outcome (model 1) varied by subgroup and outcome in ways that
were consistent with the overall results and the smaller sample size
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
P
(0.64)
(1.02)
(1.15)
(0.68)
(2.17)
(1.33)
(0.54)
(0.84)
(0.46)
(7.61)
499 (2.64)
114 (0.60)
5.69 (4.39)
No
DISCUSSION
2033
1438
120
192
218
128
410
252
102
159
86
(35.55)
(14.07)
(49.37)
349 (43.84)
13.90 (12.68)
(6.91)
(8.67)
(7.91)
(4.65)
(2.01)
23 (2.89)
cations because of the high bacterial load in the colon.17 The role of
Yes
283
112
393
26
55
69
63
37
16
tomy has been questioned in the last decade. In this study we found
that the use of MBP plus OABP significantly reduced superficial SSI,
deep SSI, organ space SSI, and anastomotic leak, which is consistent
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
0.141
0.048
<0.001
<0.001
0.588
<0.001
with the other studies that have shown benefits of preoperative MBP
P
plus OABP. Kim et al10 recently published results from the Michigan
Surgical Quality Collaborative Colectomy Project, and reported that
the administration of MBP plus OABP was associated with lower
(11.66)
(0.57)
(3.20)
(1.33)
(0.94)
(2.36)
(2.58)
(0.98)
(0.99)
(0.51)
(8.95)
788 (4.04)
135 (0.69)
5.96 (5.11)
TABLE 4. Univariable Analysis of the Association Between SSI and Outcomes
1745
122
622
260
184
460
503
191
192
99
(16.24)
(11.68)
(43.65)
60 (30.46)
12.36 (11.47)
(6.60)
(6.60)
(6.60)
(2.03)
(1.52)
2 (1.02)
NSQIP Targeted Colectomy file to show that MPB plus OABP was
Yes
13
32
23
86
4
3
and readmission.
In contrast, the literature on the role of MBP is mixed. Most
trials are too small to provide definitive conclusions, with some
0.0139
<0.001
<0.001
0.022
0.355
<0.001
0.001
0.157
<0.001
(0.71)
(3.30)
(1.33)
(0.97)
(2.24)
(2.39)
(1.05)
(0.97)
(0.51)
(8.69)
778 (4.19)
133 (0.72)
5.91 (5.18)
that there was no evidence that patients benefit from MBP; as such, it
No
1612
132
611
246
180
415
443
194
180
94
(19.45)
(1.24)
(4.80)
(2.40)
(1.51)
(5.15)
(8.17)
(1.78)
(1.42)
(0.71)
70 (6.22)
4 (0.36)
7.94 (5.95)
parenteral antibiotics and/or enema. The authors did not find evi-
8
228
219
27
17
58
92
20
16
pooled results and the fact that the trials were underpowered, with
poorly defined outcomes, and compared different regimens of bowel
Wound dehiscence
Anastomotic leak
readmission
reoperation
ventilation
Unplanned
Unplanned
Prolonged
Outcome
Mortality
UTI
PE
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with the results from a meta-analysis which concluded that combi- the 2010 survey conducted by the American Society of Colon and
nation of OABP and intravenous antibiotics significantly lowers the Rectal Surgery, which noted that 76% of surgeons routinely use
incidence of SSI compared with intravenous antibiotics alone.25 MBP, 19% selectively use it, 36% use MBP plus OABP, whereas 4%
Fry12 also concluded, based on a review of 70 years of surgical do not use any method of bowel preparation.29 The lack of standard-
literature, that MPB alone does not reduce rates of SSI, whereas oral ization of care and the presence of conflicting evidence in the
antibiotics plus intravenous antibiotics is superior to either intra- literature clearly show the complexity of the problem, and the
venous antibiotics alone or MBP. What is less clear is whether OABP difficulty in determining the best preparation method and its impact
plus MBP provides any advantage over OABP alone. RCTs have not on wound and nonwound-related outcomes.
examined this question, and observational studies such as the current There are some limitations to our study. The design of the
study and others using the NSQIP do not have sufficient numbers of NSQIP data extraction protocol limited our ability to determine
patients on OABP alone to address this question.11,18 which antibiotic and bowel preparations were used; furthermore,
The current study extends the findings of previous randomized the bowel preparation data recorded in the database reflect what was
and nonrandomized studies by addressing the question of whether prescribed in the patient medical record, and we cannot determine for
OABP plus MBP can reduce the incidence of systemic complications certain whether patients took the preparation or not. In addition, there
such as pneumonia, prolonged intubation, and sepsis. Kiran et al18 may be confounding variables not recorded in this database that may
observed an association between the use of OABP plus MBP and be associated both to the prescription of antibiotics and bowel
reductions in systemic complications, but did not draw any con- preparation products and also to the development of postoperative
clusions from these findings, nor did they attempt to propose a complications. Finally, our analysis depends on the observation of
mechanism for this association. Many previous studies have shown associations that are not statistically significant. In general, non-
the impact of the occurrence of an SSI on prolonged LOS, increased significant association could be due to a lack of statistical power;
hospital cost, and increased morbidity.14,15,26 28 Similarly, in this however, adding a single variable to a regression variable should not
study we were able to demonstrate that the reduction in SSI associ- cause significant changes in significance related to statistical power.
ated with the use of MBP plus OABP was also associated with a In addition, both the univariable and multivariable models presented
reduction in wound dehiscence, anastomotic leak, pneumonia, pro- show similar findings, suggesting that statistical power does not play
longed ventilation, sepsis, septic shock, and unplanned reoperation much of a role in our results.
and readmission. This shows that reduction in SSI associated Despite these limitations, using the NSQIP database provides
with preoperative bowel preparation may extend well beyond the a large sample from a diverse selection of hospitals throughout the
prevention of SSI, perhaps also influencing the incidence of other United States, which gives the ability to adjust for a number of
complications and potentially reducing the cost and morbidity confounding factors and draw reasonable conclusions regarding the
associated with readmission and reoperation. impact of an intervention such as bowel preparation on postoperative
We also observed a reduction in postoperative ileus, mortality, outcomes.
and LOS in patients who received MBP plus OABP, but the reduction
in SSI seemed to play only a small role in the reduction in these
outcomes that have a complex set of causes. More research is CONCLUSIONS
necessary to determine how much bowel preparation contributes Combined MBP and OABP before elective colectomy is
to improvements in these outcomes in relation to other factors that associated with a decrease in wound-related complications which
are also associated with these outcomes. Furthermore, we found that is, in turn, associated with a reduction in nonwound-related com-
there are some postoperative outcomes that were not influenced by plications and better overall postoperative outcomes. Continued use
the administration of MBP plus OABP including UTI, DVT, and PE. of combined MBP and OABP before elective colectomy is recom-
Currently, there is no consensus on the optimum bowel mended based on our study. Prospective trials are needed to establish
preparation method and whether bowel preparation should be per- the causal pathway that leads to improvement in nonwound-related
formed or not before elective colectomy. This was demonstrated by outcomes in patients undergoing bowel preparation.
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Annals of Surgery Volume XX, Number X, Month 2015 Benefits of Bowel Preparation
Copyright 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.