Abstract
Background:
Use of pre-operative bowel preparation in colorectal resection has not been examined solely in patients who have had colorectal resection with primary colostomy (Hartmann procedure). We aimed to evaluate the association of bowel preparations with short-term outcomes after non-emergent Hartmann procedure.
Patients and Methods:
The National Surgical Quality Improvement Program Participant Use File colectomy database was queried for patients who had elective open or laparoscopic Hartmann operation. Patients were grouped by pre-operative bowel preparation: no bowel preparation, oral antibiotic agents, mechanical preparation, or both mechanical and oral antibiotic agent preparation (combined). Propensity analysis was performed, and outcomes were compared by type of pre-operative bowel preparation. The primary outcome was rate of any surgical site infection (SSI). Secondary outcomes included overall complication, re-operation, re-admission, Clostridioides difficile colitis, and length of stay.
Results:
Of the 4,331 records analyzed, 2,040 (47.1%) patients received no preparation, 251 (4.4%) received oral antibiotic preparation, 1,035 (23.9%) received mechanical bowel preparation, and 1,005 (23.2%) received combined oral antibiotic and mechanical bowel preparation. After propensity adjustment, rates of any SSI, overall complication, and length of hospital stay varied significantly between pre-operative bowel regimens (p < 0.005). The use of combined bowel preparation was associated with decreased rate of SSI, overall complication, and length of stay. No difference in rate of re-operation or post-operative Clostridioides difficile infection was observed based on bowel preparation.
Conclusions:
Compared with no pre-operative bowel preparation, any bowel preparation was associated with reduced rate of SSI, but not rate of re-operation or post-operative Clostridioides difficile infection.
The role of bowel preparation before colorectal surgery has evolved over time. Historically, pre-operative bowel preparation for colorectal surgery was believed to reduce intestinal stool and bacterial burden, potentially reducing the rate of surgical site infection (SSI), anastomotic dehiscence, and peri-operative morbidity and mortality [1,2]. The choices of pre-operative bowel preparation include no preparation, mechanical bowel preparation alone, oral antibiotic bowel preparation alone, or a combination of mechanical and oral antibiotic (combined preparation). Past survey research has concluded that most surgeons continue to prescribe some type of pre-operative bowel preparation before colorectal surgery [3,4]. Currently, most of the literature supporting combined preparation has investigated all colectomies or has been limited to those patients who have anastomosis, excluding those with creation of end colostomy [5–7].
In addition to potentially reducing post-operative infectious complications after colorectal surgery, another important goal of pre-operative bowel preparation is to protect the intestinal anastomosis. This presents a unique consideration in patients for whom no anastomosis is planned. The use of pre-operative bowel preparation is not without risk and associated adverse effects, including nausea. Metabolic dysfunction such as hyper-/hyponatremia, hypokalemia, hypocalcemia, metabolic acidosis, and kidney injury has also been reported [8,9]. Given these side effects, the decision to use a pre-operative bowel regimen should be weighed carefully in colorectal resections that do not include anastomosis. The subset of patients who have stoma created after colectomy is unique, and although these patients have sometimes been included in studies, they have not been examined exclusively. Patients in this group do not have anastomosis; therefore, they may not benefit as much from pre-operative preparation.
A review of pre-operative bowel preparations and outcomes for patients with planned colorectal resection with end colostomy has not been done. Our aim was to assess the association of different bowel preparations on the short-term outcomes of patients included in the National Surgical Quality Improvement Program (NSQIP) Participant Use File colectomy database who have had elective colorectal resection with end colostomy (Hartmann procedure). The main outcome variable was the rate of any SSI. Secondary outcomes included rate of overall complication, re-operation, re-admission, Clostridioides difficile colitis, and the length of hospital stay.
Patients and Methods
Categorized as exempt from review by our hospital's Institutional Review Board, this retrospective study used the NSQIP Participant Use File colectomy database to identify patients who underwent non-emergent or elective colon and rectal resections between January 2012 and December 2017. Procedures included Current Procedural Terminology (CPT) codes 44143 (open) and 44206 (laparoscopic) for Hartmann-type procedure. Clinical and demographic data were abstracted from the database. Patients with missing information were excluded from the analysis. Additionally, to minimize risk of confounding by clinical urgency and inability to administer bowel preparation pre-operatively, all patients with the pre-operative category of sepsis, septic shock, or systemic inflammatory response syndrome, and procedures performed in an emergent setting were eliminated from the sample. Patients were categorized into four groups: no bowel preparation, mechanical preparation alone, oral antibiotic alone, and combined mechanical and oral antibiotic preparation (combined preparation).
Patient characteristics included for our study were age, gender, body mass index (BMI), and comorbidities of hypertension, ascites, chronic obstructive pulmonary disease, smoking, and steroid use. Operative wound classification was also included as a variable within each group according to which peri-operative bowel regimen was given. The reason to include operative wound classification is because even in elective operations, if there was spillage of stool, the degree of contamination could affect rates of wound infection. Laboratory values analyzed included pre-operative albumin, serum creatinine, white blood cell and platelet counts, and hematocrit levels. Finally, history of cancer diagnosis and indication for surgery were recorded. The primary end point was the rate of any SSI. Secondary outcome measures included rate of overall complication, re-operation, re-admission, Clostridioides difficile colitis, and hospital length of stay.
The American College of Surgeons NSQIP and the hospitals participating in the American College of Surgeons NSQIP are the source of the data used herein; they have not been verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors.
Statistical analysis
Baseline characteristics of the four groups were compared using descriptive statistics. Continuous variables were described using the mean and standard deviation, and categorical variables were described with the frequency and percentage. Analysis of variance or Kruskal-Wallis tests were used for continuous variables and χ2 tests or Fisher exact tests were used for categorical variables, as appropriate.
To account for confounding caused by bowel preparation selection bias, a propensity score modeling approach was used to estimate the inverse probability of treatment weight (IPTW) [10]. To build the propensity score model, boosted regression analyses for multiple treatments [11] were performed using the mode of bowel preparation administered as the outcome variable and the patient demographic variables and pre-operative risk factors as covariates (age, BMI, surgical approach, gender, smoking status, HXCOPD, HYPERMED, WTLOSS, DIALYSIS, DISCANCER, STEROID, HXCHF, ASCITES, and TRANSFUS). The laboratory variables with missing values were excluded in the propensity score model, leading to the possible imbalance among the groups even after the IPTW was performed. To address this, a sensitivity analysis was performed using the entire dataset of the laboratory markers (n = 3,571, missing for the laboratory markers, PRALBUM: 735; PRCREAT: 118; PRWBC: 102; PRHCT: 82l PRPLATE 106) and the analysis was repeated showing similar results, and hence confirming equal baseline characteristics of the groups.
The balance of the covariates among the four bowel preparation groups was compared before and after weighting using standardized mean difference. Any standardized mean difference <0.1 was considered a negligible difference, and the inverse probability of treatment weight was then adjusted in the subsequent analysis of the effect of the mode of bowel preparation on different outcomes.
Univariable and multivariable propensity score-weighted logistic regression models were used to evaluate the association between bowel preparation and the occurrence of a surgical site complication, composite complication, re-operation, re-admission, Clostridioides difficile colitis, and length of stay. Similarly, a propensity score-weighted generalized linear regression model was used to estimate the effect of bowel preparation on post-operative length of stay. A p value <0.05 was considered statistically significant. All analyses were done using R (version 3.6.1, R Core Team, Vienna, Austria).
Results
A total of 4,331 patients identified from the American College of Surgeons NSQIP Participant Use File colectomy database underwent elective Hartmann procedure (CPT codes 44143 and 44206) between 2012 and 2017 without a pre-operative diagnosis of sepsis, septic shock, or systemic inflammatory response syndrome. Of these patients, 2,040 (47.1%) did not receive any bowel preparation, 251 (4.4%) received oral antibiotic alone, 1,035 (23.9%) received mechanical preparation alone, and 1,005 (23.2%) received combined preparation before their operation. Table 1 shows that the use of standardized mean difference weights sufficiently balanced patient and procedure characteristics across modes of pre-operative bowel preparation in the cohort.
Patient and Procedure Characteristics
BMI = body mass index; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; IQR = interquartile range; MAP = combined oral and mechanical bowel preparation; MBP = mechanical bowel preparation alone; NBP = no bowel preparation; OAP = oral antibiotic bowel preparation alone; SD = standard deviation; SMD = standardized mean difference.
Outcomes
Table 2 shows rate of developing an outcome based on the type of pre-operative bowel regimen administered. A total of 617 (14.2%) patients developed any SSI, and the rates varied based on the pre-operative bowel preparation regimen administered (no bowel preparation, 17.3%; oral antibiotic alone, 8.4%; mechanical bowel preparation, 12.5%; combined preparation, 11.4%; p < 0.005). On subanalysis of the different classes of SSI, the rate of superficial and organ/space SSI also varied based on pre-operative bowel regimen (Table 2). The overall complication rate also differed by bowel preparation received and was lowest for the combined bowel preparation group (p < 0.001). Hospital length of stay varied based on the types of pre-operative preparation, with the shortest duration of six days (interquartile range [IQR], 4–9) for the combined preparation group and the longest at eight days (IQR, 5–12) for the group that did not receive any bowel preparation (p < 0.05). No differences based on bowel preparation were observed in post-operative Clostridioides difficile infection, re-operation, or re-admission (Table 2).
Unadjusted and Standardized Mean Difference-Weighted Adjusted Outcomes
IQR = interquartile range; LOS = length of stay; MAP = mechanical and oral antibiotic bowel preparation; MBP = mechanical bowel preparation; NBP = no bowel preparation; OAP = oral antibiotic bowel preparation; SMD = standardized mean difference; SSI = surgical site infection.
On univariable analysis, the use of bowel preparation was associated with decreased rate of any SSI, overall complication, and length of stay (Table 3). The incidence of any SSI was lowest in the groups that received oral antibiotic preparation alone (odds ratio [OR], 0.46; 95% confidence interval [CI], 0.28–0.75; p = 0.018), or dual preparation (OR, 0.62; 95% CI, 0.49–0.78; p < 0.001). The overall complication rate was lowest for patients who received mechanical bowel preparation (OR, 0.78; 95% CI, 0.65–0.93; p = 0.007) or combined preparation (OR, 0.7; 95% CI, 0.58–0.85; p < 0.001). The two groups also had shorter lengths of hospital stay (Table 3). There was no difference on post-operative re-admission, return to the operating room, and post-operative Clostridioides difficile colitis based on pre-operative bowel regimen. On subanalysis, the incidence of superficial SSI was lower in the oral antibiotic preparation group (OR, 0.45; 95% CI, 0.23–0.88; p = 0.02) and combined preparation group (OR, 0.48; 95% CI, 0.34–0.68; p < 0.001). The oral antibiotic and mechanical bowel groups also had a lower incidence of organ/space SSI (OR, 0.39; 95% CI, 0.18–0.82; p < 0.014 and OR, 0.61; 95% CI, 0.44–0.86; p < 0.004, respectively; Table 3).
Univariable Analysis: Associations between Outcomes and Type of Bowel Preparation
Combined preparation was oral antibiotic and mechanical bowel preparation.
OR = odds ratio; CI = confidence interval; SSI = surgical site infection.
For all analyses, the no preparation group was used as the referent.
On multivariable logistic regression analysis after adjusting for potential confounders, the use of any bowel preparation regimen predicted decreased incidence of any SSI: oral antibiotic preparation (OR, 0.46; 95% CI, 0.28–0.75; p = 0.002), mechanical bowel preparation (OR, 0.76; 95% CI, 0.60–0.96; p < 0.022) and combined preparation, (OR, 0.64; 95% CI, 0.5–0.81; p < 0.001) (Table 4). Furthermore, the use of oral antibiotic preparation and combined preparation was predictive of decreased incidence of superficial SSI, but not for deep incisional SSI. Monotherapy with oral antibiotic preparation (OR, 0.36; 95% CI, 0.17–0.75; p = 0.007) and mechanical bowel preparation (OR, 0.64; 95% CI, 0.46–0.91; p = 0.012), but not combined preparation predicted decreased organ/space SSI compared with absence of bowel preparation. Compared with no bowel preparation, mechanical bowel preparation alone was associated with increased deep incisional SSI, although this was not statistically significant (Table 4). Operative factors that were predictive of increased risk of any SSI included BMI (OR, 1.02; 95% CI, 1.00–1.03; p = 0.014), open surgical approach (OR, 1.43; 95% CI, 1.10–1.87; p = 0.009), operative time greater than 6 hours (OR, 1.87; 95% CI, 1.25–2.79; p = 0.002), and contaminated wound class (OR, 1.32; 95% CI, 1.03–1.69; p = 0.028). The use of mechanical and oral antibiotic bowel preparation was associated with a decreased rate of overall complication and shorter length of hospital stay. Bowel preparation type was not predictive of Clostridioides difficile colitis. However, history of chronic obstructive pulmonary disease (COPD), ascites and pre-operative levels of creatinine and albumin were predictive of post-operative Clostridioides difficile colitis.
Multivariable Analysis Showing Association of Bowel Preparation Method with SSIs and Overall Complications
SSI = surgical site infection; OR = odds ratio; CI = confidence interval.
For all analyses, the no preparation group was used as the referent.
Discussion
Our study showed that compared with no pre-operative preparation, the use of any type of pre-operative bowel preparation was associated with a decreased rate of any SSI, and superficial and organ/space SSI in patients who underwent the Hartmann procedure. The use of bowel preparation was also associated with decreased rate of overall complication and hospital length of stay. We found no association between the use of pre-operative bowel preparation and rate of re-operation, re-admission, or Clostridioides difficile colitis. To our knowledge, this is the first study to assess the association of pre-operative bowel preparation within this specific patient cohort. Our work suggests that pre-operative bowel preparation may decrease the risk of infectious complications and improve short-term outcomes.
Although the use of combined mechanical and oral antibiotic bowel preparation before elective colorectal surgery has been shown to decrease infectious complications and protect against anastomotic breakdown and leakage [1,2], the benefit of this practice has not been studied exclusively in patients who have received colorectal resections with end colostomy creation. Although included in some studies, this unique patient cohort has not been examined exclusively. Patients undergoing elective laparoscopic or open Hartmann procedure do not have an anastomosis to protect, and therefore, may not benefit as much from pre-operative mechanical and/or oral antibiotic preparation. Given the risks of bowel preparation and the discomfort to these patients, understanding the potential benefits of this practice is important.
Multiple studies have shown no benefit of the use of mechanical preparation alone before an elective colorectal surgery, leading some authors to recommend consider abandoning the practice [5,12–15]. A recent prospective randomized trial done by Koskenvuo et al. [16], did not demonstrate a reduction in overall morbidity or SSI in colon surgery patients, possibly because of small sample size. Despite these findings, pre-operative mechanical bowel preparation is still done by many surgeons. In a 2010 survey on SSI prevention strategies, more than two-thirds (76%) of members of the American Society of Colon and Rectal Surgeons reported the routine use of mechanical preparation before elective colorectal surgery; 36% reported always using oral antibiotics, and 55% reported never using oral antibiotic agents [17]. Additionally, two other surveys of colorectal surgeons show that physicians routine preparation their patients pre-operatively [3,4]. In fact, the current American Society of Colon and Rectal Surgeons Clinical Practice Guidelines continue to recommend mechanical and oral antibiotic preparation for elective colon and rectal surgery as level 1B evidence [18].
General and colorectal surgeons strongly support the use of oral antibiotic agents and combined (mechanical and oral antibiotic) preparation before elective colorectal resections, particularly with anastomosis, as evidenced in numerous studies [5–7]. Compared with no bowel preparation, combined preparation has been shown to reduce the risk of anastomotic breakdown and leakage after an elective colorectal surgery [6,7,19,20]. A metanalysis by McSorley et al. [21], demonstrates a decreased rate of OSSI with the use of intravenous antibiotic agents, mechanical preparation and oral antibiotics compared with mechanical preparation and intravenous antibiotic agents alone. Similarly, our study showed that for patients undergoing colorectal surgery without an anastomosis, compared with no preparation, the use of combined preparation was associated with decreased risks of any and superficial SSI. Furthermore, length of stay was shorter for patients who received pre-operative combined bowel preparation and mechanical preparation compared with no preparation. There was no association between the pre-operative bowel preparation and the risk of re-operation or re-admission in the patient cohort.
Colitis from Clostridioides difficile infection is a known complication of antibiotic use, and a higher risk has been reported among patients undergoing colorectal surgery [22]. Some small studies have reported an increased incidence of Clostridioides difficile colitis after oral antibiotic prophylaxis administered for colorectal surgery [23,24]. However, other studies that have included Clostridioides difficile colitis as an outcome variable have failed to report an association with pre-operative oral antibiotic preparation [7,25–26]. Using the Michigan Surgical Quality Collaborative Colectomy Project data, Krapohl et al. [25] evaluated the incidence of Clostridioides difficile colitis among patients who received pre-operative mechanical bowel preparation before elective colectomy between 2007 and 2009. They found no increased rate of Clostridioides difficile colitis in patients who received mechanical bowel preparation alone or combined preparation [25]. Using a similar database, Englesbe et al. [27] found no difference in the rate of Clostridioides difficile colitis among patients who received mechanical bowel preparation with oral antibiotic agents before elective colectomy. In line with the findings from these studies, we found no association between bowel preparation and risk of Clostridioides difficile colitis in patients undergoing elective Hartmann procedure. Our study showed patient-related factors such as history of COPD, ascites, pre-operative creatinine, and albumin levels as predictive of postoperative Clostridioides difficile colitis.
Our study has several strengths and potential limitations. The use of pre-operative bowel preparation has largely been studied in the context of reducing infectious complications and maintaining the integrity of an intestinal anastomosis. Studies that exclusively evaluate patients who have no risk of anastomotic breakdown are limited. Our study fills this knowledge gap and supports the benefits of combined bowel preparation regimen to this patient population. Furthermore, we observed no increased risk of Clostridioides difficile colitis as a result of using a pre-operative oral antibiotic bowel regimen in this patient population. Our study faced limitations that come with the use of a database. Using the NSQIP database, several factors could not be verified, including the specific type of bowel preparation given, the timeliness of administering the pre-operative oral antibiotic agents and compliance with mechanical bowel preparation. Additionally, operative details that are not collected by NSQIP but that might affect post-operative wound infections, such as parenteral antibiotic agents administered in the operating room before incision and wound protector use were not available for review. We also acknowledge that some eligible patients and operative procedure may not be captured by the sole use of CPT codes in querying the ACS NSQIP database.
Conclusions
Patients undergoing elective Hartmann procedure may benefit most from any pre-operative bowel preparation especially dual preparation, which has been associated with reduced infectious events, overall complications, and decreased length of stay. There has been strong support for combined bowel preparations in colorectal resections specifically with anastomosis. Our work suggests a benefit for patients undergoing end colostomy to receive pre-operative preparation compared with no preparation. Furthermore, we found an association between rate of deep incisional SSI and the use of mechanical preparation alone. Further evaluation is needed to assess the risk and benefits of using mechanical bowel preparation alone within this patient cohort.
Footnotes
Acknowledgments
The authors thank Stephanie Stebens at Henry Ford Hospital for her additional input in reviewing this manuscript. The authors thank Karla D. Passalacqua, PhD, at Henry Ford Hospital for editorial assistance.
Authors' Contributions
All authors contributed equally to this manuscript and project.
Data Availability
The datasets used and/or analyzed during the current study are not publicly available because of patient privacy and institutional policy but are available from the corresponding author on reasonable request.
Funding Information
There was no funding for this project.
Author Disclosure Statement
The authors report no proprietary or commercial interest in any product mentioned or concept discussed in this article.
