Accepted Manuscript The use of mechanical bowel preparation in laparoscopic gynecologic surgery: A decision analysis Kelly L. Kantartzis, MD, MSc, Jonathan P. Shepherd, MD, MSc PII:
S0002-9378(15)00480-9
DOI:
10.1016/j.ajog.2015.05.017
Reference:
YMOB 10400
To appear in:
American Journal of Obstetrics and Gynecology
Received Date: 20 December 2014 Revised Date:
26 April 2015
Accepted Date: 10 May 2015
Please cite this article as: Kantartzis KL, Shepherd JP, The use of mechanical bowel preparation in laparoscopic gynecologic surgery: A decision analysis, American Journal of Obstetrics and Gynecology (2015), doi: 10.1016/j.ajog.2015.05.017. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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The use of mechanical bowel preparation in laparoscopic gynecologic surgery: A
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decision analysis
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Kelly L. KANTARTZIS, MD, MSc
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Jonathan P. SHEPHERD, MD, MSc
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Division of Urogynecology, Department of Obstetrics, Gynecology, and Reproductive
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Sciences, Magee Womens Hospital, University of Pittsburgh School of Medicine,
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Pittsburgh, PA
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Corresponding author and contact for reprint requests:
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Jonathan P. Shepherd, MD, MSc
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300 Halket Street
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Pittsburgh, PA 15213
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[email protected] 15
Work Phone: 412-641-1440
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Cell Phone: 412-926-5175
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Fax: 412-641-1133
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Disclosure: The authors report no conflict of interest.
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Financial Support: None
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Paper presentation: This research was presented in an oral presentation at the 41st
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Annual Scientific Meeting for the Society of Gynecologic Surgeons (SGS), Orlando, FL,
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March 22-25, 2015
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Word Count: Abstract: 250 ; Main text: 1,738
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Condensation
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Omitting mechanical bowel preparation was preferred, but the difference between this
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and magnesium citrate was not clinically significant.
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Short Version of Title
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Bowel Preparation in Gynecologic Laparoscopy
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Abstract
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Objective:
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The use of mechanical bowel preparation prior to laparoscopy is common in
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gynecology, but its use may affect rates of perioperative events and complications. Our
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objective was to compare different mechanical bowel preparations using decision
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analysis techniques to determine the optimal preparation prior to laparoscopic
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gynecologic surgery.
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Study Design:
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A decision analysis was constructed modelling perioperative outcomes with the
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following mechanical bowel preparations: magnesium citrate, sodium phosphate,
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polyethylene glycol, enema, and no bowel preparation. Comparisons were made using
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published utility values. Secondary analyses included the percentages that had ≥1
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preoperative event and ≥1 intra- or postoperative complication.
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Results:
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Overall, the highest utility values were for no bowel preparation (0.98) and magnesium
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citrate (0.97), while the other values were: enema (0.95), sodium phosphate (0.94),
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polyethylene glycol (0.91). The difference between no bowel preparation and
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magnesium citrate was less than published minimally important differences for utilities,
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so there is likely no real difference between these strategies. The probability of having
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at least one preoperative event was lowest for no bowel preparation (1%) while the
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probability of having at least one intra- or postoperative complication was lowest with
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magnesium citrate (8%).
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Conclusions:
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The highest utilities were seen with no bowel preparation, but the absolute difference
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between no bowel preparation and magnesium citrate was less than the minimally
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important difference. With similar overall utilities, our model raises questions as to
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whether mechanical bowel preparation is a necessary step prior to laparoscopic
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gynecologic surgery. However, if a surgeon prefers a bowel preparation, magnesium
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citrate is the preferred option.
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Key Words: Gynecologic surgery, laparoscopy, mechanical bowel preparation
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Introduction
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The use of mechanical bowel preparation prior to laparoscopy is common in gynecology
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as well as other surgical specialties, yet studies across specialties have questioned its
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merit.1-3 Historically, gynecologists have prescribed preoperative mechanical bowel
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preparations in attempts to decrease the risk of infection, while also providing easier
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bowel manipulation and better visualization.4 However, many of these proposed
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benefits have never been proven, and bowel preparations may actually increase the risk
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of surgical site infection.2, 4, 5 Despite such data, a survey of gynecologic oncologists
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found that approximately half of the respondents still prescribe bowel preparations
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despite 77% acknowledging that there is not data to support such use.4
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Two recent randomized trials have shown that for both vaginal prolapse repairs and
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laparoscopic hysterectomies, mechanical bowel preparation with saline enemas
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conferred no benefit for surgeon visualization and ultimately decreased patient
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satisfaction.6, 7 This is similar to studies of both simple and more complex gynecologic
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laparoscopy which also found no difference in the surgical field or operative difficulty if
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either an oral sodium phosphate or saline enema was used preoperatively.1, 3
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Unfortunately, these studies used various mechanical bowel preparations and various
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routes of surgery thus making comparisons difficult. Our objective was to compare
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multiple different mechanical bowel preparations, including no mechanical bowel
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preparation in a decision analysis model, to determine the optimal bowel preparation
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prior to laparoscopic gynecologic surgery.
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Materials and Methods
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After institutional review board approval was obtained, a decision analysis model was
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created using TreeAge Pro (TreeAge Software, Inc, Williamstown, MA, USA). The
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decision node included the following possible mechanical bowel preparations:
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magnesium citrate, sodium phosphate, polyethylene glycol, enema, or no mechanical
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bowel preparation. Each subsequent subtree was identical for each of the 5 bowel
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preparation options. The differences in the subtrees were in the probability of each
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perioperative event or complication occurring with the different bowel preparations.
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The first branch point in each subtree was a specific preoperative, intraoperative, or
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postoperative complication/event dichotomized to present or absent. Subsequent
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braches were for other possible complications. For example, with 2 complications there
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were 4 terminal branches in the tree representing 4 possible outcomes. You could have
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both complications, neither, only the first, or only the second. This simplified version of
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the tree is displayed in Figure 1. Using this methodology, our tree was exponentially
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expanded accounting for all nine perioperative events. The model was based on a 7-
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day follow-up as most surgical complications related to bowel preparation are noted in
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this time frame. This shorter time frame improved our ability to distinguish differences
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between the preparations.
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The model included weighted average probabilities for perioperative events and
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complications from 28 published trials. When laparoscopic gynecologic trials were not
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available, colorectal, urologic, and general surgery literature was used. Eight trials taken
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from the colonoscopy literature evaluated preoperative patient outcomes specifically
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related to bowel preparations due to the greater robustness of preoperative outcomes
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which would occur regardless of whether a colonoscopy or gynecologic surgery follows
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the bowel preparation. Our model included 5 preoperative events and complications
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including nausea/vomiting/abdominal pain, diarrhea/fecal incontinence, anal discomfort,
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hypotension, and arrhythmia/seizure. We also modelled 4 intra- or postoperative
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complications including surgical site infection, abdominal infection, ileus/obstruction,
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and bowel injury/colostomy. The base case probability was a composite of all available
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data. Utility values were assigned to each perioperative event and were obtained from
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published data. Utilities which represent a measure of quality of life ranged from 0
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representing death to 1 representing perfect health.
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The primary objective was to determine which mechanical bowel preparation yielded the
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highest utility value and thus was the preferred treatment option. Secondary analyses
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include the percentage of patients that had at least one preoperative event or
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complication and the percentage with at least one intra- or postoperative complication.
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Multiple one-way sensitivity analyses were performed to test model robustness and to
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determine if a threshold value existed where the results would then favor a different
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bowel preparation. These analyses were carried out over the entire range of possible
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probability values for events and complications as well as utilities, 0 to 1.
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Results
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Complication rates and utility values were obtained from the published literature (Table
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1). Using simple roll-back methodology, the overall utility value for each mechanical
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bowel preparation was calculated. This method calculates the average utility value a
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patient will experience given the weighted average of each perioperative event and the
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resultant decrease in quality of life utility if each of these events occurs. The highest
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utility values were for no mechanical bowel preparation (0.98) and magnesium citrate
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(0.97), while the other values were as follows: enema (0.95), sodium phosphate (0.94),
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and polyethylene glycol (0.91). The difference between no mechanical bowel
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preparation and magnesium citrate was less than the published minimally important
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differences for health state utilities.31 Thus, there is likely no real difference between
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these strategies.
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When the decision analysis tree was reduced to only account for preoperative events,
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all preparations had similar utility values: no mechanical bowel preparation (1.00),
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magnesium citrate (0.98), sodium phosphate (0.98), enema (0.98), and polyethylene
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glycol (0.98). Conversely, magnesium citrate (0.99), no mechanical bowel preparation
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(0.98), and enema (0.98) had higher utilities when the tree was reduced to account only
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for intraoperative or postoperative events. Sodium phosphate (0.96) and polyethylene
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glycol (0.92) were lower in this reduced model.
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The probability of having at least one preoperative event was lowest for no mechanical
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bowel preparation (1%) versus any of the mechanical bowel preparations [magnesium
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citrate (40%), polyethylene glycol (41%), sodium phosphate (55%), and enema (60%).
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The probability of having at least one intra- or postoperative complication was lowest
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with magnesium citrate (8%) compared to no bowel preparation (16%) and other
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mechanical bowel preparations [enema (12%), sodium phosphate (22%), and
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polyethylene glycol (46%)].
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Multiple one-way sensitivity analyses were performed for the 12 probabilities at each of
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the 5 branches and additionally for all 10 utilities. The purpose of a sensitivity analysis is
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to determine if there is an alternate value for one of the input variables where the model
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would favor a different strategy. When our variables were sampled throughout the entire
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range of 0 to 1, the only thresholds identified changed the model from favoring no bowel
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preparation to favoring magnesium citrate. No mechanical bowel preparation and
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magnesium citrate are not meaningfully different due to their differential overall utility
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being less than the minimally important difference for utilities. Thus, there were no
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meaningful thresholds on one-way sensitivity analysis.
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Comment
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No mechanical bowel preparation had the highest utility value, making this option the
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preferred strategy prior to laparoscopic gynecologic surgery. However, there is likely no
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difference when this option is compared to magnesium citrate. This study confirms
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previously published data across specialties and surgical routes, highlighting that the
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elimination of mechanical bowel preparations does not negatively impact perioperative
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outcomes.5,7,32 Given that patients report higher satisfaction when bowel preparation is
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omitted6, that surgeons are unable to decipher between those who do and do not have
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a bowel preparation3, 7, and that bowel preparations may delay return of postoperative
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bowel function33, the routine use of mechanical bowel preparations should likely be
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eliminated.
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However, there are still surgeons who maintain that certain patients must undergo a
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preoperative bowel preparation. While no bowel preparation is preferred in our decision
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analysis, there was no real difference between no bowel preparation and magnesium
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citrate. Thus, if a surgeon desires a bowel preparation magnesium citrate is the
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preferred option given it has the lowest probability of pre-, intra-, and postoperative
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events compared to other mechanical bowel preparations in our model.
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Despite the mounting evidence against routine use of bowel preparations, many
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surgeons still prefer to give their patients preoperative bowel preparations.4 This lag
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between evidence and physician practice is demonstrated across medical specialties,
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but can be more pronounced in surgical disciplines.34 Studies have specifically
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addressed changing behavior of general surgeons regarding bowel preparations and
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found that at least in the short-term, a structured multi-modal educational strategy can
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improve compliance with bowel preparation recommendations.35 As more literature is
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published on this topic prior to gynecologic surgery, a similar education strategy will
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likely be needed to promote physician understanding and adoption.
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A strength of our study is the use of multiple randomized controlled trials that
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specifically evaluated bowel preparations prior to abdominal surgery and predominantly
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with a laparoscopic approach. Also, our multiple one-way sensitivity analyses
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demonstrated that varying any single variable would not change our conclusions and
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thus confirmed model robustness. A major limitation of this study is that the model
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includes literature from a wide variety of surgical specialties and not just gynecology.
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However, many of the variables included in the model, especially preoperative events,
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do not rely on the proposed surgical procedure. For example, diarrhea and fecal
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incontinence will occur with a given probability for a given mechanical bowel preparation
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no matter what surgery is planned the following day. We ultimately decided to use
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these alternative sources to improve our model where studies in laparoscopic
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gynecology were lacking.
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Another limitation is that our model primarily included objective events and did not
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include the potential subjective benefits of bowel preparations such as surgeon
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perception of surgical difficulty or patient satisfaction. We would propose that surgical
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difficulty would correlate with rates of bowel injury or obstruction and surgical infections,
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variables which were accounted for in our model. Prior research has also found that
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surgeons are poor predictors of which patients have had a bowel preparation.1 The use
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of utility values is a method for incorporating patient satisfaction as quality of life is
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measured and will decrease when events that impact patient satisfaction occur. Further
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incorporating patient satisfaction would likely make our preferred strategy of no bowel
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preparation a more favorable option as patients report higher satisfaction rates when no
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bowel preparation is used.6 Finally, our model does not specifically discuss the insertion
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of graft or mesh and the implications a bowel preparation has on potential negative
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outcomes. Given the paucity of literature on the potential complications of mesh
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placement at the time of a bowel injury, this was excluded and our model does not
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adequately answer this question. Further research surrounding placement of graft is
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needed.
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Our model adds to the current literature which questions the use of routine mechanical
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bowel preparations prior to laparoscopic gynecologic surgery. Based on our findings,
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surgeons can most likely omit preoperative bowel preparation. While surgeon behavior
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is difficult to change, the use of a structured educational tool will likely ease the
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transition.
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Table 1. Outcome probabilities and utility values
Outcome Probability (Range in Published Studies)
SC
No Outcome
Magnesium Sodium Mechanical
Enema
0.3055
Nausea/
0.1307
0.767 0.3067
(0.0313-
0.0000*
Diarrhea/ Fecal
EP
Preoperative
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Anal Discomfort
0.3265#16 0.86)17,
0.6226)12-15 13
18
0.769
0.2857$
0.0052# 19
Incontinence
(0.68(0.0700-
0.4771) 9-
0.1688)8,9
Abdominal Pain
Event
(0.0214-
TE D
Vomiting/
0.0000*
Value
Phosphate Glycol(238g)
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Citrate Bowel Prep
Utility
Polyethylene
(0.610.2857#16
0.0749#3,8
0.3673#16
16,19
0.95)17, 18, 20
0.0214#9
0.0438#9
0.0469^
0.0499^
0.700#17
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Hypotension
0.0000*
0.0143#9
Arrhythmia/
0.0000 (0-
0.0438#9
0.0143$ 9
0.0000*
0.593#18
0.0000#9 Seizure
0.0063#9
21,22
0.0078)
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0.835 0.0145#22
0.0000*
(0.720.95)17
0.2012
SC
0.0832
0.0728 (0Surgical Site
(0.0667-
(0.0145-
Infection
0.12)3, 27,
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0.0236#26 19, 22-
0.1719)
0.3488)
0.0411#3
0.900#20
19, 22-
28
27
Intraoperative/ Abdominal
(0.0309-
0.1059
TE D
0.0622
Infection
0.32)22, 24, 26, 27
EP
Complications
0.696 0.2634
(0.0139-
0.0279&
(0.642(0.1812-
0.0685#3
0.1463)3,
0.75) 18, 0.3714)
22, 24
27
20
0.0636
0.0196
Ileus/
AC C
Postoperative
29
(0.0118-
Obstruction
0.650 (0.0139-
0.0285$
0.0374#19
0.0137#3
(0.6-
3,
0.0854)
0.0667)19,26,27
0.7)18 27
ACCEPTED MANUSCRIPT
22
0.00466 Bowel
0.0021 (00.0011$
(0.0396-
0.0000#3
0.550#30
RI PT
Injury/Colostomy 0.1467) 24, 26
0.0000#3
SC
0.0667) 24, 29
M AN U
Note: Outcome probabilities were derived from weighted averages of 28 published articles. Utilities were gathered from 3 articles and one publically available online database. Probabilities and utilities have a possible range of 0 to 1.
AC C
EP
TE D
#= Single value reported in the literature so a range is not reported *= Values for No mechanical bowel prep and enema were assumed to be 0 for certain preoperative outcomes given lack of mechanism to cause this event with no or minimal intervention. $= This value was not available in the literature so baseline value was assumed to be median of other bowel preparation values. This was accounted for in sensitivity analysis by varying over entire range of 0-1. ^= This value was not available in the literature so baseline value was calculated using the ratio of nausea/ vomiting/ abdominal pain to anal discomfort from the magnesium citrate and sodium phosphate preparations. The known value for nausea/ vomiting/ abdominal pain was then divided by this multiplier of 6.5412. This assumption was accounted for in sensitivity analysis by varying over entire range of 0-1. &= This value was not available in the literature so baseline value was calculated using the ratio of surgical site infection to abdominal infection from other four preparations. The known value for surgical site infection was then divided by this multiplier of 0.8472. This assumption was accounted for in sensitivity analysis by varying over entire range of 0-1.
ACCEPTED MANUSCRIPT 23
Figure 1. Simplified decision analysis tree
The tree modeling all possible complications is too complex to graphically illustrate
AC C
EP
TE D
M AN U
SC
RI PT
here.
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT