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Incidence of cholecystectomy after bariatric surgery
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Incidence of Cholecystectomy following Bariatric Surgery Maria S. Altieri, Jie Yang, Lizhou Nie, Salvatore Docimo, Mark Talamini, Aurora D. Pryor
www.elsevier.com/locate/bios
PII: DOI: Reference:
S1550-7289(18)30167-9 https://doi.org/10.1016/j.soard.2018.03.028 SOARD3339
To appear in: Surgery for Obesity and Related Diseases Cite this article as: Maria S. Altieri, Jie Yang, Lizhou Nie, Salvatore Docimo, Mark Talamini and Aurora D. Pryor, Incidence of Cholecystectomy following Bariatric Surgery, Surgery for Obesity and Related Diseases,doi:10.1016/j.soard.2018.03.028 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 galley proof before it is published in its final citable 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.
Incidence of Cholecystectomy following Bariatric Surgery Short title: Cholecystectomy following Bariatric Surgery
Maria S. Altieri MD , MS1,, Jie Yang PhD2, Lizhou Nie MS3, Salvatore Docimo DO1, Mark Talamini MD, MBA1, Aurora D. Pryor MD1 1
Division of Bariatric, Foregut and Advanced Gastrointestinal Surgery. Department of Surgery. Stony Brook University Medical Center. Stony Brook, New York. USA
2
Department of Family, Population and Preventive Medicine, Stony Brook University Medical Center, Stony Brook, New York. USA
3
Department of Applied Mathematics and Statistics, Stony Brook University. Stony Brook, New York
** Corresponding author: Maria S. Altieri MD 100 Nichols Road, HSC T19 Stony Brook, NY 11794 Phone: 631-708-6276 Fax: 631-444-6176 Email: [email protected]
Acknowledgement We acknowledge the biostatistical consultation and biostatistical support provided by the Biostatistical Consulting Core at School of Medicine, Stony Brook University.
Accepted for an oral presentation at Obesity Week. ASMBS 2017. Washington DC.
Keywords: cholecystectomy, bariatric surgery Disclosure: Dr. Pryor is a speaker for Gore, Ethicon, Medtronic, Merck and Stryker. She has received research support from Obalon and Baronova. There are no other conflicts of interest or financial disclosures for any of the authors.
Background: Bariatric surgery predisposes patients to development of cholelithiasis and therefore the need of a subsequent cholecystectomy; however, the incidence of cholecystectomy after bariatric surgery is debated. Objective: The purpose of our study is to assess the incidence of cholecystectomy following three of the most common bariatric procedures. Setting: University Hospital, involving a large database in New York State Methods: The Statewide Planning and Research Cooperative System (SPARCS) administrative longitudinal database was used to identify all patients undergoing Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy (SG), and Laparoscopic Adjustable Gastric Banding (LAGB) between 2004-2010. Through the use of a unique identifier patients were followed to evaluate for the need of a subsequent cholecystectomy over at least five years. Cox Proportional Hazard regression analysis were used to identify risk factors for subsequent cholecystectomy. Results: During this time period, there were 15,301 LAGB procedures, 19,996 RYGB, and 1,650 SG. There were 989 (6.5%) patients who underwent cholecystectomy following LAGB, 1,931 (9.7%) patients following RYGB, and 167 (10.1%) following SG. About a quarter of follow-up cholecystectomies were performed at the same institutions. LAGB and RYGB were less likely to have a subsequent cholecystectomy compared to SG (HR 0.5, 95% CI 0.4-0.6 for LAGB and HR 0.7, 95% CI 0.6-0.9 for RYGB), Risk factors for a subsequent cholecystectomy included age, gender, race, and some comorbidities and complications (p<0.05) based on a multivariable Cox proportional hazard model. Conclusion: The rate of cholecystectomy following LAGB, RYGB, and SG was 6.5%, 9.7% and 10.1%. Patients should be counseled pre-operatively about this risk and biliary prophylaxis should be contemplated.
Keywords:. cholecystectomy, bariatric surgery
Introduction:
Gallbladder disease is common in the general population [1, 2], making cholecystectomy one of the most commonly performed procedures in the United States [3] . Bariatric surgery is a well-established risk factor for cholelithiasis, due to predisposition of cholesterol gallstone formation and neurohormonal regulation of gallbladder contractility in the obese population [4] . Fasting and rapid weight loss have been associated with bile stasis While such risks factors lead to an increased incidence of gallstone formation, the reported incidence of symptomatic cholelithiasis following bariatric surgery is between 7-15%[5]. There is an existing debate regarding concomitant cholecystectomy during the original procedure for patients who may potentially develop gallbladder disease. Opponents cite potential risks including increased operative time, increased technical challenges with port placement and exposure, potential need to convert to open procedure [6]. The risk of bile duct injury is also real, and should be considered in asymptomatic patients. Incremental reimbursement is also less for cholecystectomy at the time of bariatric surgery than for standalone cholecystectomy. In addition, others have reported that concomitant cholecystectomy during RYGB was associated with higher unadjusted mortality rates, postoperative complications, increased rate of reoperations, and increased hospital length of stay (HLOS) [7, 8]. Proponents cite the potential of rapid weight loss leading to symptomatic cholelithiasis in this patient population, requiring an additional procedure. Current practice may include selective concomitant cholecystectomy if cholelithiasis, symptomatic biliary disease, or other gallbladder abnormalities are identified before or during surgery.
Previous research looking at single institutions report incidence of cholecystectomy following certain bariatric procedures between 2.9-10.6% [9, 10]. However, larger scale, multiinstitutional data is scarce. The purpose of our study is to assess the incidence of cholecystectomy following three of the most common bariatric procedures. In addition, risk factors for subsequent cholecystectomy were identified.
Methods: This study was approved by the New York State Department of Health and the Institutional Review Board (IRB). The Statewide Planning and Research Collaborative System (SPARCS) administrative longitudinal database was used to identify all patients undergoing Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy (SG), and Laparoscopic Adjustable Gastric Banding (LAGB) between 2004-2010 through the use of ICD-9 and CPT codes. Patients were identified with a primary diagnosis code of obesity ("278.00", "278.01" and "278.02"), and primary procedure code ICD-9 code "44.38", "43.82", "43.89" and "44.95”. For outpatients after 2007, CPR codes of "43644", "43645", "43775" and "43770". Exclusion criteria included missing identifier number, age below 18 years, and missing data were excluded from analysis. Patients who underwent cholecystectomy at the time of the initial procedure or before that since 2000 were excluded (n=1,143 for LAGB, 2,772 for RYGB, and 131 for SG). In addition, patients who were lost to follow up (n=7,197) were excluded from the analysis. Through the use of a unique identifier patients were followed to evaluate for the need of a subsequent cholecystectomy over at least five years (up to 2015). Through the use of either ICD-9 or CPT procedure codes for cholecystectomy (ICD9 codes 51.21-24, ICD10 codes 0FB40ZX, 0FB40ZZ, 0FB43ZX, 0FB43ZZ, 0FT40ZZ, 0FT44ZZ, 0FB44ZX, 0FB44ZZ and
CPT codes 47562, 47563, 47564, 47570, 47600, 47605, 47610, 47612, 47620) further procedures were identified. Common bile duct injury was evaluated for subsequent cholecystectomy following bariatric surgery (ICD9 codes 51.37, 51.59, 51.39, 51.71, 51.79, 51.3, 51.69, 50.22, 50.51). Patients with cholecystectomy surgeries at the time of primary bariatric surgeries or before that since 2000, or loss-of-follow-up were excluded for analysis. Lost to follow up was defined as no follow up visit through 2015. Time to cholecystectomy was defined as the time from primary bariatric surgery discharge date to first subsequent cholecystectomy admission date if a patient had follow-up cholecystectomy, or censored at last follow-up date. Cumulative incidence of follow-up cholecystectomy after bariatric surgery and their corresponding 95% confidence intervals were constructed using the log-log method[11]. The comparison in cumulative incidences from three surgery groups was performed using log-rank test [11]. Any of patients’ characteristics, co-morbidities or complications at the time of bariatric surgery that were associated with having subsequent cholecystectomies were further considered in a multivariable Cox proportional hazard model to examine its independent association of having follow-up cholecystectomy. Hazard ratios of all possible predictors and their corresponding 95% confidence intervals were reported. Statistical significance was set at 0.05 and analysis was performed using SAS 9.4 software (SAS Institute Inc., Cary, NC).
Results: During this time period, there were 15,301 LAGB patients, 19,996 RYGB, and 1,650 SG who had follow-up data and did not have cholecystectomy at the time of bariatric surgery or before that since 2000. Cholecystectomy was performed at the time of original surgery or before that in 1,143 of LAGB patients (7.0%), 2,772 in RYGB group (12.2%), and 131 patients in SG
group (7.4%). Thus, they were excluded in the mentioned patients above. There were 989 (6.5%) patients who underwent cholecystectomy following LAGB, 1931 (9.7%) patients following RYGB, and 167 (10.1%) following SG. The average follow-up time for LAGB, RYGB, and SG patients was 5.7, 5.8, and 5.0 years, respectively. About a quarter of follow-up cholecystectomies were performed at the same institutions (26% for LAGB, 25.1% for RYGB, and 32.3% for SG). Time to cholecystectomy was 3.2+/-2.3 years following LAGB, 2.6+/-2.3 years following RYGB, and 2.7+/-2.1 years following SG. The cumulative incidences of followup cholecystectomy by surgery type are shown in Table 1. Table 1 suggest that SG patients were more likely to have subsequent cholecystectomy (p-value < 0.0001). For example, at postsurgery year 7, incidence of cholecystectomy after SG was 13.0% (95% CI: 11.0%-15.3%), while such incidences after LAGB and RYGB were 7.9% (95% CI: 7.4%-8.4%) and 11.2% (95% CI: 10.7%-11.7%), respectively.
Significant risk factors for a subsequent cholecystectomy included age, gender, race, region, with/without some comorbidities and complications including bacterial disease, cardiac complication, etc. (p<0.05) based on a multivariable Cox proportional hazard model. Female Patients and younger age patients were more likely to undergo a subsequent cholecystectomy (Table 2). Patients with depression and weight loss were more likely to undergo subsequent cholecystectomy (HR 1.2, 95% CI 1.1-1.3, p-value 0.0015 and HR 1.3, 95% CI 1.03-1.7, p-value 0.03). Patients with liver disease were less likely to undergo subsequent cholecystectomy (HR 0.8, 95% CI 0.7-0.9, p-value 0.0018). LAGB and RYGB were less likely to have a subsequent cholecystectomy compared to SG (HR 0.5, 95% CI 0.4-0.6 for LAGB and HR 0.7, 95% CI 0.6-0.9 for RYGB, Table 2). When evaluating CBD injury, 5 patients (0.12%) experienced a CBD injury during a subsequent laparoscopic cholecystectomy.
Discussion: It is debatable whether routine cholecystectomy should be performed at the time of the original weight loss procedure. There are no current guidelines for prophylactic cholecystectomy, however concomitant cholecystectomy is not performed routinely during most primary bariatric procedures. Many are arguing that despite the higher prevalence of gallstones in this patient population, the rate of subsequent cholecystectomy remains low, while concomitant cholecystectomy leads to potentially higher rates of complication [7, 12, 13]. A study published in 2008 of 70, 287 patients showed a significant reduction in concomitant cholecystectomies during bariatric surgery as rate dropped from 26% in 2001 to 3.7% seven years later [7]. While some studies have examined the rate of subsequent cholecystectomy, multi institutional, long term data (> 10 years follow-up) is lacking. The current study examines the rate of cholecystectomy over a ten-year period and it shows that the rate of cholecystectomy following bariatric surgery is relatively low, as it is lowest for LAGB patients (6.5%) and highest following SG (10.1%). RYGB had an incidence of subsequent cholecystectomy of 9.7%, however the rate of concomitant cholecystectomy was the highest in this group (5.2%). That may reflect selection of at risk patients. Interestingly, a small percentage of patients have a subsequent cholecystectomy at their original institution, while majority will have the procedure at another institution. Mean time to subsequent cholecystectomy was 2.6-3.2 years depending on the procedure. Common bile duct injury was 0.12%, which was higher than previously reported rate of 0.08% [14]. Surgeons should be aware of the higher rate of CDB surgery following bariatric surgery.
This data supports the notion that concurrent cholecystectomy during bariatric surgery is not necessary unless symptomatic cholelithiasis is present, as incidence of subsequent cholecystectomy is relatively low. Previous studies have suggested that expectant approach is preferred, as majority of patients may not require subsequent cholecystectomy
[10, 15]
. In
addition, it has been shown that cholecystectomy during primary procedure may lead to increased complication rates, operative time, and length of stay[7, 12]. The most dreaded complication during laparoscopic cholecystectomy is bile duct injury (BDI) and reported incidence is approximately every one in 200 patients. However, if patients have known symptoms pre-operatively, preferred treatment should be cholecystectomy at time of initial surgery, as worsening of symptoms may lead to more complicated surgery. Torngvist et. al. showed that the risk of BDI increases with an increase in inflammation [16]. In our study, rate of cholecystectomy was higher than we have previously reported as 0.12% of patients who have a subsequent cholecystectomy experienced a CBD injury requiring a reconstruction. General surgeons must be aware that laparoscopic cholecystectomy following bariatric surgery may be association with higher rate of CBD injury. Others have examined the incidence of cholecystectomy following bariatric procedures. In a study of prospectively collected single institution data, Tsirline et al., reported a rate of subsequent cholecystectomy of 7.8% in 1398 patients [10]. In contrast to the current study, the rate of cholecystectomy was highest in the LRYGB group (10.6%), compared to LAGB (2.9%) and LSG (3.5%). The authors reported that the frequency was highest within the first six months and declined subsequently, which differs to our study as mean time to subsequent cholecystectomy was > 2 years. This may be in part due to patients seeking care outside their bariatric hospital. In addition, the amount of EWL within the first 3 months was a predictor for
subsequent cholecystectomy [10]. Another study followed 109 patients over 10 years following LAGB, LRYGB, and LSG[17]. The rate of cholecystectomy was 11%, although 17.4% of patients had postoperative gallstone formation. Similarly to Tsirline, weight loss was higher in patients requiring subsequent cholecystectomy[17]. Another study which followed patients over a shorter period between 2009-2011, reported a higher rate of symptomatic gallstones in LRYGB and LSG groups compared to LAGB [18]. Limitations of this study include the limitations inherited to the use of an administrative database. Unfortunately, certain clinical variables cannot be assessed with this data, including the use of Ursodiol administration and any association of Excess Weight Loss between the original surgery and subsequent cholecystectomy. Data regarding these associations have been examined elsewhere [10, 18-20]. About a quarter of the subsequent cholecystectomies were performed at the original institutions, however, we do not have any information regarding the reasons. In addition, if cholecystectomy was performed outside the state of New York, this information would not be captured in this dataset. The strengths of this manuscript include the large dataset and the ability to follow these patients across many institutions many and many years in the state of New York. Conclusion: The rate of cholecystectomy following LAGB, RYGB, and SG was 6.5%, 9.7% and 10.1%. Following accounting for other variables, patients following either LAGB and RYGB were less likely to undergo a subsequent cholecystectomy. In addition, CBD injury had a higher rate of 0.12% during subsequent cholecystectomy. Patients should be counseled pre-operatively about this risk. The risks and benefits of ursodiol or prophylactic cholecystectomy should also be considered.
Disclosure: Dr. Pryor is a speaker for Gore, Ethicon, Medtronic, Merck and Stryker. She has received research support from Obalon and Baronova. There are no other conflicts of interest or financial disclosures for any of the authors.
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Schirmer BD, Winters KL, and Edlich RF. Cholelithiasis and cholecystitis. J Long Term Eff Med Implants, 2005. 15(3): 329-38.
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Tucker ON, Fajnwaks P, Szomstein S, Rosenthal RJ. Is concomitant cholecystectomy necessary in obese patients undergoing laparoscopic gastric bypass surgery? Obes Surg, 2008. 22: 2450-4.
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Subhas G, Gupta A, Bhullar J, et al. Prolonged (longer than 3 hours) laparoscopic cholecystectomy: reasons and results. Am Surg, 2011. 77(8): 981-4.
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Dorman RB, Zhong W, Abraham AA, et al. Does concomitant cholecystectomy at time of Roux-en-Y gastric bypass impact adverse operative outcomes? Obes Surg, 2013. 23 (11): 1718-26.
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Caushaj PF. Routine gallbladder screening not necessary in patients undergoing laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis, 2006. 2(1): 41-6.
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Törnqvist B, Waage A, Zheng Z, Ye W, Nilsson M. Severity of Acute Cholecystitis and Risk of Iatrogenic Bile Duct Injury During Cholecystectomy, a Population-Based Case-Control Study. World J Surg, 2016. 40(5): 1060-7.
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Table 1: Estimated Cumulative Incidence Rates and corresponding 95% Confidence Intervals at Year 3, 5, 7 and 10 after surgery by Primary Surgery Types among Patients
Table 2: Association between Patients’ Characteristics, Clinical Information, Complications & Comorbidities and having a follow-up Cholecystectomy Surgery based on a Multivariable Cox Proportional Hazard model *: p-values were based on Type-3 Wald chi-squared test from a Cox PH model. Highlighted values are significant
Table 1: Estimated Cumulative Incidence Rates and corresponding 95% Confidence Intervals at Year 3, 5, 7 and 10 after surgery by Primary Surgery Types among Patients Initial Surgery Type
Year 3 after surgery
Year 5 after surgery
Year 7 after surgery
Year 10 after surgery
Band
3.7% (3.4%-4.0%)
5.7% (5.3%-6.1%)
7.9% (7.4%-8.4%)
11.2% (10.1%-12.4%)
Bypass
6.9% (6.6%-7.3%)
9.1% (8.7%-9.6%)
11.2% (10.7%-11.7%)
14.4% (13.6%-15.3%)
Sleeve
7.4% (6.1%-8.8%)
9.9% (8.4%-11.6%)
13.0% (11.0%-15.3%)
17.3% (13.8%-21.0%)
Overall
5.6% (5.4%-5.8%)
7.7% (7.4%-8.0%)
9.8% (9.5%-10.2%)
13.2% (12.5%-13.8%)
Table 2: Association between Patients’ Characteristics, Clinical Information, Complications & Comorbidities and having a follow-up Cholecystectomy Surgery based on a Multivariable Cox Proportional Hazard model Variable
Level
Hazard Ratio
p-value*
Patients’ Characteristics Age Group Patient Type Race
Sex
36-50 vs 18-35
0.77 (0.71 ,0.84)
>=51 vs 18-35
0.59 (0.53 ,0.66)
Inpatient vs Outpatient
1.02 (0.86 ,1.20)
0.9
Black vs White
0.61 (0.53 ,0.69)
<.0001
Hispanic vs White
1.11 (0.99 ,1.26)
Other vs White
0.98 (0.88 ,1.09)
Female vs Male
1.26 (1.15 ,1.39)
<.0001
<.0001
Surgery Related Clinical Information Length-of-stay Surgery Type
1.02 (1.00 ,1.03)
0.1
Band vs Sleeve
0.51 (0.43 ,0.61)
<.0001
Bypass vs Sleeve
0.73 (0.62 ,0.86)
Complication Infection
Yes vs No
1.91 (1.21 ,3.00)
0.0051
Cardiac Complication
Yes vs No
1.33 (0.93 ,1.89)
0.1
Atelectasis
Yes vs No
1.26 (0.91 ,1.75)
0.2
Digestive
Yes vs No
1.25 (0.88 ,1.77)
0.2
Pneumonia
Yes vs No
0.92 (0.61 ,1.39)
0.7
Surgical Error
Yes vs No
1.29 (1.03 ,1.62)
0.02
Systemic Inflammation
Yes vs No
0.70 (0.17 ,2.92)
0.6
Comorbidity
Variable
Level
Hazard Ratio
p-value*
Chronic pulmonary disease
Yes vs No
1.08 (1.00 ,1.18)
0.2
Depression
Yes vs No
1.16 (1.06 ,1.27)
0.0015
Diabetes without chronic complications
Yes vs No
0.94 (0.86 ,1.02)
0.1
Hypertension
Yes vs No
0.96 (0.89 ,1.04)
0.3
Liver disease
Yes vs No
0.78 (0.67 ,0.91)
0.0018
Rheumatoid arthritis/collagen vas
Yes vs No
1.39 (1.04 ,1.87)
0.02
Weight loss
Yes vs No
1.32 (1.03 ,1.69)
0.03
*: p-values were based on Type-3 Wald chi-squared test from a Cox PH model.
image
Incidence of Cholecystectomy following Bariatric Surgery Maria S. Altieri, Jie Yang, Lizhou Nie, Salvatore Docimo, Mark Talamini, Aurora D. Pryor
www.elsevier.com/locate/bios
PII: DOI: Reference:
S1550-7289(18)30167-9 https://doi.org/10.1016/j.soard.2018.03.028 SOARD3339
To appear in: Surgery for Obesity and Related Diseases Cite this article as: Maria S. Altieri, Jie Yang, Lizhou Nie, Salvatore Docimo, Mark Talamini and Aurora D. Pryor, Incidence of Cholecystectomy following Bariatric Surgery, Surgery for Obesity and Related Diseases,doi:10.1016/j.soard.2018.03.028 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 galley proof before it is published in its final citable 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.
Incidence of Cholecystectomy following Bariatric Surgery Short title: Cholecystectomy following Bariatric Surgery
Maria S. Altieri MD , MS1,, Jie Yang PhD2, Lizhou Nie MS3, Salvatore Docimo DO1, Mark Talamini MD, MBA1, Aurora D. Pryor MD1 1
Division of Bariatric, Foregut and Advanced Gastrointestinal Surgery. Department of Surgery. Stony Brook University Medical Center. Stony Brook, New York. USA
2
Department of Family, Population and Preventive Medicine, Stony Brook University Medical Center, Stony Brook, New York. USA
3
Department of Applied Mathematics and Statistics, Stony Brook University. Stony Brook, New York
** Corresponding author: Maria S. Altieri MD 100 Nichols Road, HSC T19 Stony Brook, NY 11794 Phone: 631-708-6276 Fax: 631-444-6176 Email: [email protected]
Acknowledgement We acknowledge the biostatistical consultation and biostatistical support provided by the Biostatistical Consulting Core at School of Medicine, Stony Brook University.
Accepted for an oral presentation at Obesity Week. ASMBS 2017. Washington DC.
Keywords: cholecystectomy, bariatric surgery Disclosure: Dr. Pryor is a speaker for Gore, Ethicon, Medtronic, Merck and Stryker. She has received research support from Obalon and Baronova. There are no other conflicts of interest or financial disclosures for any of the authors.
Background: Bariatric surgery predisposes patients to development of cholelithiasis and therefore the need of a subsequent cholecystectomy; however, the incidence of cholecystectomy after bariatric surgery is debated. Objective: The purpose of our study is to assess the incidence of cholecystectomy following three of the most common bariatric procedures. Setting: University Hospital, involving a large database in New York State Methods: The Statewide Planning and Research Cooperative System (SPARCS) administrative longitudinal database was used to identify all patients undergoing Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy (SG), and Laparoscopic Adjustable Gastric Banding (LAGB) between 2004-2010. Through the use of a unique identifier patients were followed to evaluate for the need of a subsequent cholecystectomy over at least five years. Cox Proportional Hazard regression analysis were used to identify risk factors for subsequent cholecystectomy. Results: During this time period, there were 15,301 LAGB procedures, 19,996 RYGB, and 1,650 SG. There were 989 (6.5%) patients who underwent cholecystectomy following LAGB, 1,931 (9.7%) patients following RYGB, and 167 (10.1%) following SG. About a quarter of follow-up cholecystectomies were performed at the same institutions. LAGB and RYGB were less likely to have a subsequent cholecystectomy compared to SG (HR 0.5, 95% CI 0.4-0.6 for LAGB and HR 0.7, 95% CI 0.6-0.9 for RYGB), Risk factors for a subsequent cholecystectomy included age, gender, race, and some comorbidities and complications (p<0.05) based on a multivariable Cox proportional hazard model. Conclusion: The rate of cholecystectomy following LAGB, RYGB, and SG was 6.5%, 9.7% and 10.1%. Patients should be counseled pre-operatively about this risk and biliary prophylaxis should be contemplated.
Keywords:. cholecystectomy, bariatric surgery
Introduction:
Gallbladder disease is common in the general population [1, 2], making cholecystectomy one of the most commonly performed procedures in the United States [3] . Bariatric surgery is a well-established risk factor for cholelithiasis, due to predisposition of cholesterol gallstone formation and neurohormonal regulation of gallbladder contractility in the obese population [4] . Fasting and rapid weight loss have been associated with bile stasis While such risks factors lead to an increased incidence of gallstone formation, the reported incidence of symptomatic cholelithiasis following bariatric surgery is between 7-15%[5]. There is an existing debate regarding concomitant cholecystectomy during the original procedure for patients who may potentially develop gallbladder disease. Opponents cite potential risks including increased operative time, increased technical challenges with port placement and exposure, potential need to convert to open procedure [6]. The risk of bile duct injury is also real, and should be considered in asymptomatic patients. Incremental reimbursement is also less for cholecystectomy at the time of bariatric surgery than for standalone cholecystectomy. In addition, others have reported that concomitant cholecystectomy during RYGB was associated with higher unadjusted mortality rates, postoperative complications, increased rate of reoperations, and increased hospital length of stay (HLOS) [7, 8]. Proponents cite the potential of rapid weight loss leading to symptomatic cholelithiasis in this patient population, requiring an additional procedure. Current practice may include selective concomitant cholecystectomy if cholelithiasis, symptomatic biliary disease, or other gallbladder abnormalities are identified before or during surgery.
Previous research looking at single institutions report incidence of cholecystectomy following certain bariatric procedures between 2.9-10.6% [9, 10]. However, larger scale, multiinstitutional data is scarce. The purpose of our study is to assess the incidence of cholecystectomy following three of the most common bariatric procedures. In addition, risk factors for subsequent cholecystectomy were identified.
Methods: This study was approved by the New York State Department of Health and the Institutional Review Board (IRB). The Statewide Planning and Research Collaborative System (SPARCS) administrative longitudinal database was used to identify all patients undergoing Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy (SG), and Laparoscopic Adjustable Gastric Banding (LAGB) between 2004-2010 through the use of ICD-9 and CPT codes. Patients were identified with a primary diagnosis code of obesity ("278.00", "278.01" and "278.02"), and primary procedure code ICD-9 code "44.38", "43.82", "43.89" and "44.95”. For outpatients after 2007, CPR codes of "43644", "43645", "43775" and "43770". Exclusion criteria included missing identifier number, age below 18 years, and missing data were excluded from analysis. Patients who underwent cholecystectomy at the time of the initial procedure or before that since 2000 were excluded (n=1,143 for LAGB, 2,772 for RYGB, and 131 for SG). In addition, patients who were lost to follow up (n=7,197) were excluded from the analysis. Through the use of a unique identifier patients were followed to evaluate for the need of a subsequent cholecystectomy over at least five years (up to 2015). Through the use of either ICD-9 or CPT procedure codes for cholecystectomy (ICD9 codes 51.21-24, ICD10 codes 0FB40ZX, 0FB40ZZ, 0FB43ZX, 0FB43ZZ, 0FT40ZZ, 0FT44ZZ, 0FB44ZX, 0FB44ZZ and
CPT codes 47562, 47563, 47564, 47570, 47600, 47605, 47610, 47612, 47620) further procedures were identified. Common bile duct injury was evaluated for subsequent cholecystectomy following bariatric surgery (ICD9 codes 51.37, 51.59, 51.39, 51.71, 51.79, 51.3, 51.69, 50.22, 50.51). Patients with cholecystectomy surgeries at the time of primary bariatric surgeries or before that since 2000, or loss-of-follow-up were excluded for analysis. Lost to follow up was defined as no follow up visit through 2015. Time to cholecystectomy was defined as the time from primary bariatric surgery discharge date to first subsequent cholecystectomy admission date if a patient had follow-up cholecystectomy, or censored at last follow-up date. Cumulative incidence of follow-up cholecystectomy after bariatric surgery and their corresponding 95% confidence intervals were constructed using the log-log method[11]. The comparison in cumulative incidences from three surgery groups was performed using log-rank test [11]. Any of patients’ characteristics, co-morbidities or complications at the time of bariatric surgery that were associated with having subsequent cholecystectomies were further considered in a multivariable Cox proportional hazard model to examine its independent association of having follow-up cholecystectomy. Hazard ratios of all possible predictors and their corresponding 95% confidence intervals were reported. Statistical significance was set at 0.05 and analysis was performed using SAS 9.4 software (SAS Institute Inc., Cary, NC).
Results: During this time period, there were 15,301 LAGB patients, 19,996 RYGB, and 1,650 SG who had follow-up data and did not have cholecystectomy at the time of bariatric surgery or before that since 2000. Cholecystectomy was performed at the time of original surgery or before that in 1,143 of LAGB patients (7.0%), 2,772 in RYGB group (12.2%), and 131 patients in SG
group (7.4%). Thus, they were excluded in the mentioned patients above. There were 989 (6.5%) patients who underwent cholecystectomy following LAGB, 1931 (9.7%) patients following RYGB, and 167 (10.1%) following SG. The average follow-up time for LAGB, RYGB, and SG patients was 5.7, 5.8, and 5.0 years, respectively. About a quarter of follow-up cholecystectomies were performed at the same institutions (26% for LAGB, 25.1% for RYGB, and 32.3% for SG). Time to cholecystectomy was 3.2+/-2.3 years following LAGB, 2.6+/-2.3 years following RYGB, and 2.7+/-2.1 years following SG. The cumulative incidences of followup cholecystectomy by surgery type are shown in Table 1. Table 1 suggest that SG patients were more likely to have subsequent cholecystectomy (p-value < 0.0001). For example, at postsurgery year 7, incidence of cholecystectomy after SG was 13.0% (95% CI: 11.0%-15.3%), while such incidences after LAGB and RYGB were 7.9% (95% CI: 7.4%-8.4%) and 11.2% (95% CI: 10.7%-11.7%), respectively.
Significant risk factors for a subsequent cholecystectomy included age, gender, race, region, with/without some comorbidities and complications including bacterial disease, cardiac complication, etc. (p<0.05) based on a multivariable Cox proportional hazard model. Female Patients and younger age patients were more likely to undergo a subsequent cholecystectomy (Table 2). Patients with depression and weight loss were more likely to undergo subsequent cholecystectomy (HR 1.2, 95% CI 1.1-1.3, p-value 0.0015 and HR 1.3, 95% CI 1.03-1.7, p-value 0.03). Patients with liver disease were less likely to undergo subsequent cholecystectomy (HR 0.8, 95% CI 0.7-0.9, p-value 0.0018). LAGB and RYGB were less likely to have a subsequent cholecystectomy compared to SG (HR 0.5, 95% CI 0.4-0.6 for LAGB and HR 0.7, 95% CI 0.6-0.9 for RYGB, Table 2). When evaluating CBD injury, 5 patients (0.12%) experienced a CBD injury during a subsequent laparoscopic cholecystectomy.
Discussion: It is debatable whether routine cholecystectomy should be performed at the time of the original weight loss procedure. There are no current guidelines for prophylactic cholecystectomy, however concomitant cholecystectomy is not performed routinely during most primary bariatric procedures. Many are arguing that despite the higher prevalence of gallstones in this patient population, the rate of subsequent cholecystectomy remains low, while concomitant cholecystectomy leads to potentially higher rates of complication [7, 12, 13]. A study published in 2008 of 70, 287 patients showed a significant reduction in concomitant cholecystectomies during bariatric surgery as rate dropped from 26% in 2001 to 3.7% seven years later [7]. While some studies have examined the rate of subsequent cholecystectomy, multi institutional, long term data (> 10 years follow-up) is lacking. The current study examines the rate of cholecystectomy over a ten-year period and it shows that the rate of cholecystectomy following bariatric surgery is relatively low, as it is lowest for LAGB patients (6.5%) and highest following SG (10.1%). RYGB had an incidence of subsequent cholecystectomy of 9.7%, however the rate of concomitant cholecystectomy was the highest in this group (5.2%). That may reflect selection of at risk patients. Interestingly, a small percentage of patients have a subsequent cholecystectomy at their original institution, while majority will have the procedure at another institution. Mean time to subsequent cholecystectomy was 2.6-3.2 years depending on the procedure. Common bile duct injury was 0.12%, which was higher than previously reported rate of 0.08% [14]. Surgeons should be aware of the higher rate of CDB surgery following bariatric surgery.
This data supports the notion that concurrent cholecystectomy during bariatric surgery is not necessary unless symptomatic cholelithiasis is present, as incidence of subsequent cholecystectomy is relatively low. Previous studies have suggested that expectant approach is preferred, as majority of patients may not require subsequent cholecystectomy
[10, 15]
. In
addition, it has been shown that cholecystectomy during primary procedure may lead to increased complication rates, operative time, and length of stay[7, 12]. The most dreaded complication during laparoscopic cholecystectomy is bile duct injury (BDI) and reported incidence is approximately every one in 200 patients. However, if patients have known symptoms pre-operatively, preferred treatment should be cholecystectomy at time of initial surgery, as worsening of symptoms may lead to more complicated surgery. Torngvist et. al. showed that the risk of BDI increases with an increase in inflammation [16]. In our study, rate of cholecystectomy was higher than we have previously reported as 0.12% of patients who have a subsequent cholecystectomy experienced a CBD injury requiring a reconstruction. General surgeons must be aware that laparoscopic cholecystectomy following bariatric surgery may be association with higher rate of CBD injury. Others have examined the incidence of cholecystectomy following bariatric procedures. In a study of prospectively collected single institution data, Tsirline et al., reported a rate of subsequent cholecystectomy of 7.8% in 1398 patients [10]. In contrast to the current study, the rate of cholecystectomy was highest in the LRYGB group (10.6%), compared to LAGB (2.9%) and LSG (3.5%). The authors reported that the frequency was highest within the first six months and declined subsequently, which differs to our study as mean time to subsequent cholecystectomy was > 2 years. This may be in part due to patients seeking care outside their bariatric hospital. In addition, the amount of EWL within the first 3 months was a predictor for
subsequent cholecystectomy [10]. Another study followed 109 patients over 10 years following LAGB, LRYGB, and LSG[17]. The rate of cholecystectomy was 11%, although 17.4% of patients had postoperative gallstone formation. Similarly to Tsirline, weight loss was higher in patients requiring subsequent cholecystectomy[17]. Another study which followed patients over a shorter period between 2009-2011, reported a higher rate of symptomatic gallstones in LRYGB and LSG groups compared to LAGB [18]. Limitations of this study include the limitations inherited to the use of an administrative database. Unfortunately, certain clinical variables cannot be assessed with this data, including the use of Ursodiol administration and any association of Excess Weight Loss between the original surgery and subsequent cholecystectomy. Data regarding these associations have been examined elsewhere [10, 18-20]. About a quarter of the subsequent cholecystectomies were performed at the original institutions, however, we do not have any information regarding the reasons. In addition, if cholecystectomy was performed outside the state of New York, this information would not be captured in this dataset. The strengths of this manuscript include the large dataset and the ability to follow these patients across many institutions many and many years in the state of New York. Conclusion: The rate of cholecystectomy following LAGB, RYGB, and SG was 6.5%, 9.7% and 10.1%. Following accounting for other variables, patients following either LAGB and RYGB were less likely to undergo a subsequent cholecystectomy. In addition, CBD injury had a higher rate of 0.12% during subsequent cholecystectomy. Patients should be counseled pre-operatively about this risk. The risks and benefits of ursodiol or prophylactic cholecystectomy should also be considered.
Disclosure: Dr. Pryor is a speaker for Gore, Ethicon, Medtronic, Merck and Stryker. She has received research support from Obalon and Baronova. There are no other conflicts of interest or financial disclosures for any of the authors.
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Table 1: Estimated Cumulative Incidence Rates and corresponding 95% Confidence Intervals at Year 3, 5, 7 and 10 after surgery by Primary Surgery Types among Patients
Table 2: Association between Patients’ Characteristics, Clinical Information, Complications & Comorbidities and having a follow-up Cholecystectomy Surgery based on a Multivariable Cox Proportional Hazard model *: p-values were based on Type-3 Wald chi-squared test from a Cox PH model. Highlighted values are significant
Table 1: Estimated Cumulative Incidence Rates and corresponding 95% Confidence Intervals at Year 3, 5, 7 and 10 after surgery by Primary Surgery Types among Patients Initial Surgery Type
Year 3 after surgery
Year 5 after surgery
Year 7 after surgery
Year 10 after surgery
Band
3.7% (3.4%-4.0%)
5.7% (5.3%-6.1%)
7.9% (7.4%-8.4%)
11.2% (10.1%-12.4%)
Bypass
6.9% (6.6%-7.3%)
9.1% (8.7%-9.6%)
11.2% (10.7%-11.7%)
14.4% (13.6%-15.3%)
Sleeve
7.4% (6.1%-8.8%)
9.9% (8.4%-11.6%)
13.0% (11.0%-15.3%)
17.3% (13.8%-21.0%)
Overall
5.6% (5.4%-5.8%)
7.7% (7.4%-8.0%)
9.8% (9.5%-10.2%)
13.2% (12.5%-13.8%)
Table 2: Association between Patients’ Characteristics, Clinical Information, Complications & Comorbidities and having a follow-up Cholecystectomy Surgery based on a Multivariable Cox Proportional Hazard model Variable
Level
Hazard Ratio
p-value*
Patients’ Characteristics Age Group Patient Type Race
Sex
36-50 vs 18-35
0.77 (0.71 ,0.84)
>=51 vs 18-35
0.59 (0.53 ,0.66)
Inpatient vs Outpatient
1.02 (0.86 ,1.20)
0.9
Black vs White
0.61 (0.53 ,0.69)
<.0001
Hispanic vs White
1.11 (0.99 ,1.26)
Other vs White
0.98 (0.88 ,1.09)
Female vs Male
1.26 (1.15 ,1.39)
<.0001
<.0001
Surgery Related Clinical Information Length-of-stay Surgery Type
1.02 (1.00 ,1.03)
0.1
Band vs Sleeve
0.51 (0.43 ,0.61)
<.0001
Bypass vs Sleeve
0.73 (0.62 ,0.86)
Complication Infection
Yes vs No
1.91 (1.21 ,3.00)
0.0051
Cardiac Complication
Yes vs No
1.33 (0.93 ,1.89)
0.1
Atelectasis
Yes vs No
1.26 (0.91 ,1.75)
0.2
Digestive
Yes vs No
1.25 (0.88 ,1.77)
0.2
Pneumonia
Yes vs No
0.92 (0.61 ,1.39)
0.7
Surgical Error
Yes vs No
1.29 (1.03 ,1.62)
0.02
Systemic Inflammation
Yes vs No
0.70 (0.17 ,2.92)
0.6
Comorbidity
Variable
Level
Hazard Ratio
p-value*
Chronic pulmonary disease
Yes vs No
1.08 (1.00 ,1.18)
0.2
Depression
Yes vs No
1.16 (1.06 ,1.27)
0.0015
Diabetes without chronic complications
Yes vs No
0.94 (0.86 ,1.02)
0.1
Hypertension
Yes vs No
0.96 (0.89 ,1.04)
0.3
Liver disease
Yes vs No
0.78 (0.67 ,0.91)
0.0018
Rheumatoid arthritis/collagen vas
Yes vs No
1.39 (1.04 ,1.87)
0.02
Weight loss
Yes vs No
1.32 (1.03 ,1.69)
0.03
*: p-values were based on Type-3 Wald chi-squared test from a Cox PH model.