pennington 2014
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Use of mechanical bowel preparation and oral antibiotics for elective
colorectal procedures in children: Is current practice evidence-based?
Elliot C. Pennington a, Christina Feng a, Shawn D. St. Peter b, Saleem Islam c, Adam B. Goldin d,Fizan Abdullah e, Shawn J. Rangel a,⁎a Boston Children’ s Hospital and Harvard Medical School, Boston, Massachusettsb Children's Mercy Hospitals & Clinics, Kansas City, Missouric University of Florida College of Medicine, Gainesville, Floridad Seattle Children's Hospital, Seattle, Washingtone Johns Hopkins University, Baltimore, Maryland
a b s t r a c ta r t i c l e i n f o
Article history:
Received 26 January 2014
Accepted 27 January 2014
Key words:
Mechanical bowel preparation
Non-absorbable oral antibioticsl
colorectal surgery
Antibiotic prophylaxis
Purpose: It is well established through randomized trials that oral antibiotics given with or without a
mechanical bowel preparation (MBP) prior to colorectal procedures reduce complications, while MBP given
alone provides no benet. We aimed to characterize trends surrounding bowel preparation in children and
determine whether contemporary practice is evidence-based.
Methods: Retrospective analysis of patients undergoing colorectal procedures at 42 children ’s hospitals (1/2/
2007-12/31/2011) was performed. Patients were analyzed for diagnosis, pre-admission status, and inpatient
bowel preparation. Bowel preparation was considered evidence-based if oral antibiotics were utilized with or
without a MBP.
Results: 49% of all patients were pre-admitted (n = 5,473), and the most common diagnoses were anorectal
malformations (55%), inammatory bowel disease (26%), and Hirschsprung’s Disease (19%). The most
common preparation approaches were MBP alone (54.3%), MBP + oral antibiotics (18.8%), and oral
antibiotics alone (4.2%), although signicant variation was found in hospital-specic rates for each approach
(MBP alone: 0-96.1%, MBP + oral antibiotics: 0-83.6%, orals alone: 0-91.6%, p b 0.0001). Only 22.9% of all
patients received an evidence-based preparation (range by hospital: 0-92.3%, p b 0.0001), and this ratedecreased signicantly during the ve-year study period (27.6% in 2007 vs. 17.3% in 2011, p b 0.0001).
Conclusion: According to the best available clinical evidence, less than a quarter of all children pre-admitted
for elective colorectal procedures receive a bowel preparation proven to reduce infectious complications.
© 2014 Elsevier Inc. All rights reserved.
The rates of infectious complications associated with colorectal
surgery are among the highest with respect to elective procedures
performed in adults and children alike. Postoperative complications
for patients with inammatory bowel disease occur in up to 55% of
patients, and patients undergoing colorectal operations for Hirsch-
sprung’s disease may experience a complication in close to 40% of
cases [1,2]. Given the relatively high burden of infectious complica-
tions attributable to colorectal procedures, many prophylactic
strategies have been utilized to mitigate these events in the
perioperative setting. Intravenous antibiotics at the time of surgery
are widely considered the standard of care in this regard, however
opinions remain mixed about the role of mechanical bowel prepara-
tion (MBP) and oral antibiotics as prophylactic adjuncts to further
decrease the risk of complications.
The published evidence examining the prophylactic effectiveness
of MBP and non-absorbable oral antibiotics in adult colorectal surgery
is fairly extensive. Several meta-analyses incorporating data from
high-quality randomized controlled trials havermly established that
non-absorbable oral antibiotics used with or without a MBP
signicantly reduce complications, while the administration of a
MBP alone (without oral antibiotics) provides no benet. Although no
published trial has compared oral antibiotics alone with oral
antibiotics combined with a MBP, data from two large, prospective,
multi-center colorectal outcomes databases have suggested that oral
antibiotics combined with a MBP signicantly reduce infectious
complications compared with MBP alone [3,4]. From this pool of
relatively high-quality clinical evidence, two conclusions surrounding
colorectal prophylaxis can be reached: 1) Oral non-absorbable
antibiotics should be administered (with or without a MBP) as a
prophylactic adjunct to intravenous antibiotics for elective colorectal
procedures, and 2) MBP should never be given alone (without oral
antibiotics) for this purpose.
Journal of Pediatric Surgery 49 (2014) 1030–1035
⁎ Corresponding author at: Boston Children’s Hospital 300 Longwood Avenue, Fegan
3 Boston, MA 02115. Tel.: + 1 617 355 3040; fax: +1 617 730 0752.
E-mail address: [email protected] (S.J. Rangel).
http://dx.doi.org/10.1016/j.jpedsurg.2014.01.048
0022-3468/© 2014 Elsevier Inc. All rights reserved.
Contents lists available at ScienceDirect
Journal of Pediatric Surgery
j o u r n a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / j p e d s u r g
http://dx.doi.org/10.1016/j.jpedsurg.2014.01.048http://dx.doi.org/10.1016/j.jpedsurg.2014.01.048http://dx.doi.org/10.1016/j.jpedsurg.2014.01.048mailto:[email protected]://dx.doi.org/10.1016/j.jpedsurg.2014.01.048http://dx.doi.org/10.1016/j.jpedsurg.2014.01.048http://www.sciencedirect.com/science/journal/http://www.sciencedirect.com/science/journal/http://dx.doi.org/10.1016/j.jpedsurg.2014.01.048http://dx.doi.org/10.1016/j.jpedsurg.2014.01.048mailto:[email protected]://dx.doi.org/10.1016/j.jpedsurg.2014.01.048http://crossmark.crossref.org/dialog/?doi=10.1016/j.jpedsurg.2014.01.048&domain=pdf
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With these considerations, the aims of this study were twofold: 1)
To characterize overall and hospital-specic variation in pre-admis-
sion and the use of different bowel preparation strategies for
commonly performed colorectal procedures in children, and 2) To
assess overall and hospital-specic variation in the utilization of
bowel preparation strategies that arecurrently supportedby thehigh-
quality evidence cited above.
1. Methods
After obtaining IRB approval, we performed a 5-year (1/2/2007-
12/31/2011) retrospective cohort study of all patients aged 3 months
to 18 years, admitted from the outpatient setting who underwent an
elective colorectal procedure at 42 children’s hospitals using the
Pediatric Health Information System (PHIS) database. Hospitals that
provide PHIS data are members of the Children’s Hospital Association
(Shawnee Mission, KS), and include freestanding, non-competing
children’s hospitals across the United States. Patient-level data
available through the PHIS database includes the following: demo-
graphic and payer information; primary and secondary International
Classi cation of Diseases, Ninth Revision, Clinical Modi cation (ICD-9-
CM) diagnostic and procedural codes; and date-stamped billing data
for a range of diagnostic tests, therapeutic procedures, and adminis-
tration of pharmacologic agents.
1.1. Cohort de nitions
Patients were identied using a search algorithm of 40 ICD-9-CM
colorectal procedural codes used to identify colorectal procedures.
These included 20 pullthrough or anorectoplasty procedures involving
the colon, rectum or anus, 17 procedures involving colon resections
with or without a colo-enteric anastomosis, and 3 procedures for
colostomy creation, revision or closure. Cases where other procedures
were performed concomitantly on the esophagus, stomach, or
urogenital system were excluded as this may have impacted the
decision to utilize a bowel preparation on the basis of enteral tolerance
or for an indication other than colorectal prophylaxis.
Pre-admission was dened as a pre-operative hospital stay of 1-2calendar days. Patients who had an emergency department (ED) charge
during the same admissionwere excluded in order to limit the cohort to
only those electively admitted from the ambulatory setting. The
medicationprolesof allpatientswho were pre-admittedwere assessed
for Poly-ethylene Glycol (PEG) and Magnesium Citrate-based enteral
solutions, Eryrthomycin-base, and Neomycin Sulfate. Patients receiving
eitherof the enteral solutions were considered as havingreceiveda MBP
and patients receiving either (or both) Erythromycin base or Neomycin
Sulfate were considered having received oral antibiotics.
1.2. Analysis
The cohort was analyzed for demographic information, pre-
operative diagnosis, pre-admission status, and the type of bowelpreparation used. Rates of pre-admission, use of different bowel
preparation strategies, and utilization of evidence-based bowel
preparations were calculated for the entire cohort and for each
hospital. Given the strength and homogeneity of available evidence
from adult patients, we considered a patient to have received an
evidence-based bowel preparation if they received any oral antibiotics
(Erythromicin base or Neomycin Sulfate) with or without a
mechanical bowel preparation. Chi-square analysis was used to
compare proportions between groups and the Cochran-Armitage
test for trend was used to compare rates over time. All statistical
analysis was performed using SAS v9.3 (SAS Institute Inc., Cary, NC).
2. Results
A total of 7,056 patients underwent an elective colorectal
procedure during the study period. The most common diagnoses
included anorectal malformations (ARM) in 42.6% (3005/7056),
inammatory bowel disease (IBD) in 20.1% (1417/7056), and
Hirschsprung’s Disease (HD) in 14.9% (1051/7056). Within the cohort
of patients with IBD, 42.3% had ulcerative colitis, 39.3% had Crohn ’s
Disease, and 18.4% had mixed colitis. Of note, 21.4% of the cohort
(1,513/7056) did not have a preoperative diagnosis identifying a
specic colorectal condition. As it was our intent to examine practice
variationin the context of specic pediatricdiseases, we chose to limit
our analysis on the three most common conditions associated with
elective colorectal procedures in children (ARM’s, HD and IBD).
Demographic data for this sub-cohort of children (n = 5,473) is
presented in Table 1. The median age was 17 months (IQR: 6-
137 months), and 53.8% were male. The median number of patients
per hospital was 116.5 (range: 21-774).
2.1. Pre-admission rates
The overall rate of pre-admission for the entire cohort was 47.5%
(2,599/5,473) and this varied signicantly by pre-operative diagnosis
(HD: 63.8%; ARM: 46.2%; IBD: 38.2%; p b 0.0001). Of the pre-admitted
cohort, 43% had a preoperative length of stay of one day and 4.5% two
days. A 12-fold variation in pre-admission rates was observed across
hospitals (range: 7-86%, p b 0.0001), and the magnitude of thisvariation was even greater when analyzed by individual diagnosis
(ARM range: 0-91.2; IBD range: 0-90.0%; HD range: 0-100%,
p b 0.0001 for each diagnosis, Fig. 1-C).
2.2. Bowel preparation strategies
In the pre-admitted cohort, 54.3% (n = 1,412)received PEG alone,
18.8% (n = 488) received PEG along with oral antibiotics, 4.2% (n =
108) received oral antibiotics alone, and 22.7% (n = 591) received
neither PEG nor oral antibiotics. Fifty-seven (2.2%) patients received
an electrolyte laxative solution (e.g. Magnesium Citrate). This relative
preference for bowel preparation approach was similar for each of the
three diagnoses. Of the children receiving any oral antibiotics with or
without a MBP (n = 596), 46.8% received Neomycin Sulfate as theonly oral antibiotic, 3.9% received Erythromycin base as the only oral
Table 1
Demographic information, pre-admission rates, and bowel preparation strategies for patients undergoing elective colorectal procedures at 42 children ’s hospitals 2007-2011.
Pre-operative diagnosis n (%) Median age in months (+/- IQR) Male (%) Preadmission rate (%) Preadmission bowel preparation strategy
MBP (%) Orals (%) MBP + Orals (%)
Hirschsprung’s Disease 1051 (19.2) 12 (6-48) 74.7 63.8 59.7 3.9 21.2
Ano-rectal Malformations 3005 (54.9) 9 (5-20) 48.0 46.2 54.2 4.3 14.6
Inammatory Bowel Disease 1417 (25.9) 183 (152-205) 50.8 38.2 48.0 4.2 26.4
Ulcerative Colitis 603 (11.0) 178 (138-201) 49.6 41.5 52.4 3.6 26.0
Crohn’s Disease 554 (10.1) 192 (169-213) 50.2 32.9 43.4 3.9 24.7
Mixed Colitis 260 (4.8) 175 (150-197) 54.6 42.3 45.5 6.4 30.0
All 5473 (100) 17 (6-137) 53.8 47.4 54.3 4.2 18.8
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Fig. 1. A Variation in pre-admission rates and associated bowel preparation strategy in patients undergoing elective colorectal procedures for ano-rectal malformations at 42
children's hospitals. B Variation in pre-admission rates and associated bowel preparation strategy in patients undergoing elective colorectal procedures for In ammatory Bowel
Disease at 42 children's hospitals. C Variation in pre-admission rates and associated bowel preparation strategy in patients undergoing elective colorectal procedures for
Hirschsprung’s Disease at 42 children's hospitals.
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antibiotic, and 49.4% received both agents 90.1% (n = 2365) received
intravenous antibiotics at the time of surgery.
The rates of different bowel preparation approaches varied
signicantly across hospitals (PEG alone: 0-96.1%; PEG + oral
antibiotics: 0-83.6%; oral antibiotics alone: 0-91.6%, p b .0001 for
each approach, Fig. 1-C). When analyzed by individual diagnosis,
signicant variability between hospitals persisted although PEG alone
remained the most common preparation strategy used.
2.3. Evidence-based practice
The overall utilization rate of a bowel preparation approachsupported by the best available adult evidence shown to reduce
infectious complications was 22.9% (596/2599), and this rate varied
signicantly among hospitals (range: 0-92.3%, p b 0.0001, Fig. 2). No
patient received an evidence-based preparation in 13 (31%) of the 42
hospitals examined during the ve-year study period.
2.4. Trends over time
The rate of pre-admission decreased signicantly during the study
period, (51.6% in 2007 vs. 41.4% in 2011, p b 0.0001). The relative
proportion of patients receiving PEG alone increased by 42% (41.2% in
2007 vs. 59.0% in 2011, p b 0.0001), while the rates of all other
preparation strategies remained unchanged or decreased. The relative
proportion of patients receiving a bowel preparation approach shown
to reduce infectious complications in adult patients decreased by 37%
during the study period, from 27.6% in 2007 to 17.3% in 2011
(p b 0.0001, Fig. 3).
3. Discussion
In this study of 42 freestanding children’s hospitals, we found
signicant variation in the rates of pre-admission associated with
elective colorectal surgery and an equally striking variation in the
Fig. 2. Variation in the proportion of pre-admitted patients undergoing elective colorectal procedures who received an evidence-based bowel preparation treatment. (either oral
antibiotics only or oral antibiotics combined with a mechanical bowel preparation).
Fig. 3. Variation in pre-admission rates and associated bowel preparation strategy over time in patients undergoing elective colorectal procedures at 42 children's hospitals.
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preferred approach to bowel preparation. Perhaps even more striking
was thending that the majority of children pre-admitted for elective
colorectal procedures received a bowel preparation shown to be
ineffective in high-quality clinical studies involving adult patients.
Furthermore, the relative proportion of children receiving a bowel
preparation that has been shown to reduce infectious complications
appears to be decreasing over time.
The reasons for the broad variation observed in our study (and
apparent poor compliance with evidence-based guidelines) are likely
complex and multi-factorial. One possibility is that pediatric surgeons
may not be familiar with the strength of evidence in support of oral
antibiotics, and conversely, against the routine use of MBP alone for
colorectal prophylaxis. In this regard, there exist many high-quality
randomized clinical trials in the adult literature comparing the
ef cacy of different bowel preparation strategies. The majority of
these have examined the use of mechanical bowel preparation (e.g.
PEG) compared to no preparation [5–8]. The most comprehensive of
these reviews, from the Cochrane Collaboration published in 2011,
included 18 randomized controlled trials with a total of 5,805
patients. Their analysis denitively showed that mechanical prepara-
tion as a sole adjunct to IV antibiotics at the time of surgery conferred
no benet compared to IV antibiotics alone [8]. Other meta-analyses
have come to the same conclusion [9,10].
The benet of oral non-absorbable antibiotics as an adjunct tointravenous antibiotics has also been extensively studied and
conrmed through a multitude of randomized trials. In a meta-
analysis of 16 such trials that included 2,669 patients, the addition
of oral non-absorbable antibiotics to standard parenteral antibiotics
at the time of surgery reduced the risk of surgical site infection by
43% compared with parenteral antibiotics alone [11]. There are
currently no published trials that have examined whether a MBP
should be combined with oral antibiotics to increase their ef cacy.
However, the results from two large, consortium-based multi-center
colorectal collaborative studies have suggested that the combination
of MBP and oral antibiotics reduces infectious complications by more
than half when compared with a mechanical preparation alone or no
preparation (neither a mechanical preparation or oral antibiotics)
[3,4]. Although neither of these studies was able to provide insightinto whether the ef cacy of oral antibiotics is affected with the
addition of a MBP, it would seem that both approaches are associated
with a signicant reduction in the risk infectious complications. Taken
collectively, the available evidence in the adult population would
strongly suggest that oral antibiotics should always be given as a
prophylactic adjunct (with or without a MBP), while mechanical
preparation alone should never be used for this purpose.
The marked variation in practice mayalso be explained in part by a
lack of equipoise among pediatric surgeons with the relevance of
existing data to the pediatric population. It is important to note that
the “high-quality” evidence cited above is entirely derived from the
adult colorectal experience. While the evidence is clear that mechan-
ical bowel preparation offers no benet in adults, the use of MBP and
non-absorbable oral antibiotics has not been as extensively studied inchildren. One recent multi-center retrospective review of children
undergoing colostomyclosureshowed that MBP actually increasedthe
risk of wound infection (14.4% vs. 5.8%) and length of stay (5.6 vs
4.4 days), while the addition of oral antibiotics had no effect [12].
Another study of a similar cohort of patients undergoing colostomy
closure forARM’s found no benet in the addition of oral antibiotics to
MBP in the rate of infectious complications (13% vs 17%) [13]. To date
there have been no prospective studies of any type comparing bowel
preparation strategies in the pediatric population. Given this limited
pediatric data, we are challenged with the question: Are the results
from high-quality, adult-focused studies generalizable to the pediatric
population?Althoughwe would alltend to agreethat “childrenare not
small adults” when it comes to colorectal diseases and their operative
management, the relative concentration and species of colonic
bacteria are similar between children and adults by the rst year of
life. This would suggest that interventions to reduce bacterial
concentration in the colon and rectum are likely relevant to all
patients undergoing colorectal procedures, young and old alike [14].
Thendings in this study must be carefully considered in the context
of its limitations. This study was based on the retrospective analysis of
administrative data and some degree of error (including miscoding,
misclassication, or omitted data) is inherent. In this regard, 22.7% of
patients admitted prior to surgery received neither a mechanical
preparation nor oral antibiotics. It was not possible to establish why
these patients were pre-admitted, although plausible reasons may
include social and travel considerations, preoperative diagnostic testing,
and anesthesia evaluation for patients with complex care conditions,
among others. Furthermore, some patients may have been admitted to
undergo a “modied” bowel preparation using a clear liquid diet. It is
also plausible that pediatric surgeons may utilize MBP for reasons other
than prophylaxis, such as decreasing the preoperative stool burden in
chronically constipated children (e.g. anorectal malformations). It could
be argued that MBP in these cases may make the operation technically
easier, reduce operative time and cumulative anesthetic exposure, and
even overall cost. While this has not been studied and would certainly
be a reasonable indication for using a MBP, there appears to be little
justication for omitting oral antibiotics as an additional adjunct given
their establishedprophylactic value. Finally,we werenot ableto examinebowel preparation practices in the cohort of patients that were not pre-
admitted. Many of these patients, especially those older patients with
IBD, may have received oral antibiotics at home resulting in an
underestimation of the overall compliance with the level-one evidence
derived from the adult literature.Wide variability was found among children’s hospitals in the
practice of pre-admission and bowel preparation strategies for
children undergoing elective colorectal procedures. The majority of
patients received bowel preparations that have not been shown to be
effective in reducing infectious complications, and this apparent gap
between the available evidence and clinical practice appears to be
growing over time. These ndings may have important implications
for pediatric surgical practice given the relatively high prevalence of
colorectal conditions in children, high cost associated with pre-admission, and quality of life considerations as nasogastric tubes are
frequently required for the administration of MBP’s. We owe it to our
patients to develop consensus guidelines around existing high-quality
evidence, and to develop the collaborative infrastructure to support
rigorous comparative effectiveness studies where equipoise remains
elusive and variation in care great.
References
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[3] Cannon JA, Altom LK, Deierhoi RJ, et al. Preoperative oral antibiotics reducesurgical site infection following elective colorectal resections. Dis Colon Rectum2012;55:1160–6.
[4] Englesbe MJ, Brooks L, Kubus J, et al. A statewide assessment of surgical siteinfection following colectomy: the role of oral antibiotics. Ann Surg2010;252:514–9 [discussion 519–520].
[5] Pineda CE, Shelton AA, Hernandez-BoussardT, et al. Mechanicalbowel preparationin intestinal surgery: a meta-analysis and review of the literature. J GastrointestSurg 2008;12:2037–44.
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[11] Bellows CF, Mills KT, Kelly TN, et al. Combination of oral non-absorbable andintravenous antibiotics versus intravenous antibiotics alone in the prevention of surgical site infections after colorectal surgery: a meta-analysis of randomizedcontrolled trials. Tech Coloproctol 2011;15:385–95.
[12] Serrurier K, Liu J, Breckler F, et al. A multicenter evaluation of the role of mechanical bowel preparation in pediatric colostomy takedown. J Pediatr Surg2012;47:190–3.
[13] Breckler FD, Rescorla FJ, Billmire DF. Wound infection after colostomy closure forimperforate anus in children: utility of preoperative oral antibiotics. J Pediatr Surg2010;45:1509–13.
[14] Palmer C, Bik EM, DiGiulio DB, et al. Development of the human infant intestinal
microbiota. PLoS Biol 2007;5:e177.
Discussion
MALE VOICE: - - from Houston. Thank you. That was a fantastic
summary, but I kind of was waiting for the punch line. Did you
make a difference?
DR. PENNINGTON: The study really isn't designed to say whether or
not it makes a difference, but based on the best available evidence,
which is primarily in adults, the use of oral antibiotics does make a
difference, and three-quarters of children in our series are not
getting that.
MALE VOICE: Again, back to your point, those studies were done in
adults. Children are not little adults. Yes, we probably should just
accept what adults do but in this case where you have this large
series that did not, it would have been interesting to see if you
made a difference or not.
DR. PENNINGTON: Sure. There is a small amount of data in children, all
retrospective reviews, mostly single study that sort of shows
conicting evidence about whether mechanical bowel prep and
oral antibiotics are as useful, but that remains to be studied and
we're involved in a large propensity-based analysis that will hope
to answer that question. So stay tuned.
DR. LOVVORN: Okay, thank you, Dr. Pennington.
1035E.C. Pennington et al. / Journal of Pediatric Surgery 49 (2014) 1030–1035