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Impact of Oral Ursodeoxy cholic Acid on Gallstone Formation Following Laparascopic Sleeve Gastrectomy for morbid obesity. An Egyptian Study
Tamer M. Nabil (M.D) (1), Ahmed H. Khalil (M.D, MRCS)(2), Kareem Gamal (M.D)(3), Salah  S.Soliman (4)
1: Department of general surgery Beni Suef University.
2: Department of general surgery Cairo University.
3: Department of Reproductive Health, National Research Center, Egypt.
4-Department of general surgery Fayoum University
Abstract: Background: Obesity is a worldwide epidemic. It is associated with serious comorbidities. Laparoscopic sleeve gastrectomy (LSG) is an accepted long term definitive solution for obesity and its associated health hazards. Gall bladder stone formation is a postoperative complication of LSG. Several factors are implicated in its occurrence. The use of Ursodeoxy cholic acid (UDCA) after LSG is a proposed solution to reduce the incidence of cholelithiais. Patients and methods: This prospective study was conducted between July2015 and March 2018 in Cairo & Beni-Suef university hospitals. Two hundred patients were included and were randomly and equally divided into 2 groups after having LSG for morbid obesity. Group (A): received UDCA (250mg twice daily for 6 months) as prophylactic measure against gall stone formation. Group (B) was used as a control. It included 154 (77%) females and 46 males ((23%) with a mean initial body mass index of 47.1 � 5.08 (35-69 kg/m2) and 45.8�6.39 ( 36-67 kg/m2) in group A&B respectively. The mean age was 30.4 �5.9 (18-50years ) in group A while in group B the mean age was 31.7�5.4 (19-52 years). Those with history of previous bariatric surgery or cholecystectomy were excluded.  Abdominal ultrasound was done at 3,6,9 and 12 months for all patients to detect gall stones. Results: After sleeve gastrectomy, the use of UDCA in group A patients decreased the incidence of gall stones formation to 6% compared to 40% in the control group (p=0.001)  Other parameters as age , gender, initial body mass index(BMI) and excess body weight loss at 6 months didn�t significantly affect the results. Conclusion: using UDCA after LSG for 6 months is effective in prevention of gall stone formation.
 
Keywords: sleeve gastrectomy, morbid obesity, gall stones, ursodeoxy cholic acid.
Introduction:
Obesity is the second HYPERLINK "https://en.wikipedia.org/wiki/Preventable_causes_of_death" \o "Preventable causes of death"preventable cause of death worldwide after cigarette smoking. It is one of the most serious HYPERLINK "https://en.wikipedia.org/wiki/Public_health" \o "Public health"public health problems of the 21st�century [1].Sleeve gastrectomy (SG), also called greater curvature, vertical or longitudinal  gastrectomy, is a very effective surgical tool for definitive treatment of morbid obesity as well as its associated comorbidities[2,3]. Both diet regimen & bariatric surgery are associated with increased risk of developing gall bladder stones particularly with rapid weight loss[4]. Gall bladder stones commonly occur 6 months after surgery. It may be silent or symptomatic and diagnosis is based on abdominal ultrasound [5,6]. The use of ursodeoxy cholic acid (UDCA) has been advocated as a prophylactic measure against postoperative cholelithiasis [7]. The aim of this study is to show the incidence of cholelithiasis post sleeve gastrectomy with and without prophylaxis using UDCA in morbidly obese patients who were free of gall bladder stones preoperatively.
Patients and methods:
This prospective study was conducted in both Cairo & Beni-suef university hospitals during the period between July 2015 and March 2018. Two hundred patients were included in the study and were divided equally and randomly into two groups:
Group A: included 100 morbid obese patients underwent LSG with postoperative prophylaxis using UDCA(250mg twice daily for 6 months).
Group B: included 100 morbid obese patients underwent LSG and were used as a control group.
Both groups had the same inclusion criteria in the form of morbid obese patients with body mass index (BMI) > 40 kg/m2 or BMI > 35 kg/m2 with associated comorbidity as hypertension, type II diabetes mellitus& hyperlipidemia. Exclusion criteria of  both groups were patients with previous bariatric surgery or cholecystectomy , those who were preoperatively diagnosed to have gall stones or endocrinal disease as hypothyroidism and patients > 60 or < 18 years old. All patients were subjected to proper history taking, full clinical examination and investigations aiming at proper assessment of obesity and any associated comorbidities.
Laboratory investigations included complete blood count, fasting blood sugar, full liver and kidney functions and coagulation profile. Abdominal ultrasonography was done to exclude those having cholelithiasis. Chest x ray, pulmonary function tests , electrocardiography (ECG) and echocardiography we done to all patients to assess the chest and cardiac conditions. Patients were informed about the possible complications and an informed consent was signed.
Postoperative care: in addition to the routine postoperative follow up, all patients were instructed to follow specific diet regimen in the form of sugar free fluids during the first two weeks then sugar free semisolids were added starting the third week. Fat and carbohydrate free mashed food is allowed starting the 5th week. Physical exercise is encouraged 3 times weekly starting the second week after surgery. All patients were followed up monthly in the outpatient clinic to monitor the body weight loss and to detect any postoperative problems. Abdominal ultrasonography was done to all patients every 3 months for one year to detect gall bladder stones. Patients in group (A) were instructed to receive UDCA 250mg tablets twice daily for 6 months. Statistical analysis: results were expressed as number (%). Comparison between categorical data [n (%)] was performed using Chi square test. Statistical analysis was performed using computer program IBM SPSS (Statistical Package for the Social Science; IBM corp, USA (version 19 windows). P value d" 0.05 was considered significant.
Results:
This prospective study was conducted on 200 morbidly obese patients and  were divided randomly into 2 equal groups:
Group A: included 100 morbid obese patients who received UDCA (250mg twice daily) after LSG  for  6 months.
Group B:  included 100 morbid obese patients who underwent LSG and was used as a control group.
The study included 154 females (77%) and 46 males (23%). There was no significant difference between both groups regarding the age, gender, initial BMI and percentage of excess body weight loss (EBWL) at 6 months of the patients. The demographic data of the patients is illustrated in table (1).
Table (1): demographic data of the patients in both groups.
Group AGroup BP valueAge(years)
Range
Median
Mean
St. deviation
18-50
30.5
30.4
5.9
19-52
31
31.7
5.4

0.106Gender
Male
female

21
79
25
75
0.615Initial BMI(kg/m2)
Range
Mean
Median
St. deviation

35-69
47.1
45
5.08

36-67
45.8
46
6.3


0.109Excess body weight loss at 6 months (%)
Range
Mean
Median
St.Deviation


15-120
63.1
65.5
14.6


17-116
66.4
66
19.8



0.181
Postoperative administration of UDCA showed to be significantly effective in preventing gall stones. In group (A): six patients (6%) developed gall bladder stones (p value: 0.001) while in group (B) 40 patients (40%) developed gall stones. Table (2) shows the effect of UDCA in preventing gall bladder stones.

Table  (2): effect of UDCA in preventing gall stones.
Developed gall stones Percentage (%)P valueGroup (A)66%0.001Group (B)4040%
Other variables as age, gender, initial BMI and excess weight loss after 6 months didn't show any significant role in the development of gall bladder stones as shown in table (3).
Table (3) :  role of age gender, initial BMI & EBWL at 6 months in development of cholilithiasis.
Developed gall stones (n=46)Did not develop gall stones(n=154)P valueAge
< 25 yrs. (n= 48)

25-45yrs (n= 148)
>45 yrs. (n= 4)
10 (20.8%)

34 (23%)
2  (50%)
38 (79.2%)

114 (77.0%)
2 (50.0%)0.412Gender
Male(n=46)
Female (n=154)
8 (17.4%)
38 (24.7%)
38 (82.6%)
116 (75.3%)0.303Initial BMI
35-40kg/m2(n=7)
40-50kg/m2(n=141)
>50kg/m2(n=52)

4  (57.1%)
30 (21.3%)
12 (23.1%)
3    (42.9%)
111 (78.7%)
40   (76.9%)0.089EBWL percentage at 6 months
<50 %    (n=38)
50-60 % (n=62)
>60 %    (n=100)


12 (31.6%)
10 (16.1%)
24   (24%)


26(68.4%)
52(83.9%)
76(76%)
0.193
 Forty six patients (23%) developed gall stones in this study among whom 30 patients (65 %) were diagnosed at 6 months after surgery, while 11 patients (24 %) were detected 9 months postoperative. The remaining 5 patients (11%) developed cholelithiasis one year after surgery. Table (4) demonstrates the timing of developing gall stones after LSG.

Table (4): timing of developing gall stones
3 months6 months9 months12 monthsCases developed gall stones n=46 (23%)
0
30 (65%)
11 (24%)
5 (11%)
According to clinical presentation 26 patients (56.5%) presented with nausea and vomiting. Upper abdominal Pain was the main complaint in 16 patients (34.8%). The remaining 4 patients (8.7%) were asymptomatic. Table (5) shows different clinical presentations of patients developing gall bladder stones.

Table (5): clinical presentation of patients developed gall stones.
PresentationNumberPercentageNausea & vomiting2656.5%Pain1634.8%Asymptomatic48.7%
No significant intolerable side effects of UDCA occurred and all patients followed full regimen of medication.
Discussion:
Morbid obesity is considered a worldwide epidemic and is associated with multiple comorbidities that reduce life expectancy and markedly impair the quality of life [8]. Sleeve gastrectomy is one of the most popular bariatric surgery that provides effective solution for morbid obesity and its associated health hazards, thus significantly improving the quality of life [9]. Gall bladder stones are common, the prevalence of which in developed countries ranges between 6% and 16% [10]. In addition 35-38% of morbidly obese patients develop cholelithiasis post bariatric surgery during weight loss [11&12]. Rapid weight loss more than 1.5 kg or 1.5 % of total body weight per week increases the risk of developing gall bladder stones 18 folds [13&14]. Several factors have been implicated in the development of postoperative cholelithiasis. The liver of obese patient secretes supersaturated bile with excess cholesterol, mucin, calcium and prostaglandins levels beyond its soluble capacity. The high cholesterol level in bile is due to its excessive mobilization from fatty tissue. Another contributing factor is gall bladder stasis due to impaired contractility and emptying allowing precipitation of cholesterol in bile [15-19]. Pharmacological agents stimulating frequent gall bladder emptying are helpful in prevention [20]. Efforts have been made to prevent gall bladder stones formation post bariatric surgery. Concomitant cholecystectomy& bariatric surgery was adopted by some centers while others found this solution unnecessary due to increased operative time, hospital stay as well as post operative  complications. Raziel and collegue as well as Angrisani and colleague documented that concomitant prophylactic cholecystectomy and bariatric surgery is associated with prolonged operative time, hospital stay and postoperative morbidity and should be done in cases preoperatively diagnosed to have cholelithiasis [21&22]. The use of UDCA was another proposed solution for prophylaxis against cholelithiasis post bariatric surgery and proved to be significantly effective. It acts by decreasing cholesterol secretion in bile thus preventing formation of lithogenic bile and gall stones [23&24].The guidelines for perioperative nutritional, metabolic and nonsurgical support of the bariatric surgery patient recommend routine ultrasound examination within the first six months after bariatric surgery to detect gall stones as they are commonly formed during this period [25]. In this series abdominal ultrasound was done every 3 months for one year. Patients with gall stones may remain asymptomatic or present clinically with classic picture or even with picture of complications as obstructive jaundice or pancreatitis. In our study 26 patients (56.5%) presented with nausea and vomiting. Upper abdominal Pain was the main complaint in 16 patients (34.8%). The remaining 4 patients (8.7%) were asymptomatic. In 2016 Manatsathit  and colleagues reported that  253  patients underwent  laparoscopic  sleeve  gastrectomy.  Ultimately, 96 patients met inclusion criteria and were evaluated. The incidence of  gallstone  formation  was  47.9%  (46/96),  and  the  incidence  of symptomatic  gallstones  was  22.9%  (22/96).  None  of  the  weight loss  parameters  during  the  early  and  late  postoperative  period were significantly different between the patients  who developed gall stones and those who did not [26].
Results showed that using UCDA has  significant  impact  in decreasing the incidence of development of gall stones 6 % in group A(p=0.001) compared to 40 % in group B, which is concordant with Miller et al 2003 who reported that of 152 patients, 76 were randomized to placebo and 76 to 500 mg of UDCA daily for 6 months to assess the role of UDCA in prophylaxis against  development  of  gall  stones  after  restrictive  bariatric surgeries. Gall stone formation was significantly less frequent with UDCA than with placebo at 12 months 3% versus  22%,  and  8%  versus  30%  at  24  months, cholecystectomy in 4.7% versus 12%, respectively [27].
This also goes hand in hand with the results published in  2016 by Abdallah and colleague who conducted  a  study on  a  total  of  406  patients  (124  males,  282 females) with a mean age of 32.1 � 9.4 years were included. The mean  baseline BMI was  50.1  �  8.3  kg/  m2 . Patients were subdivided into two groups: Group I, which did not receive prophylactic treatment with UCDA after LSG; and Group II, which received UCDA therapy for 6 months after LSG. Group I  comprised  159  patients,  and  Group  II  comprised  247  patients.  The  two  groups  showed  comparable  demographics,  EBWL , and decrease in BMI at 6 and 12 months after LSG. Eight patients (5%) developed gall stones in Group I, whereas no patients in Group II did (P = 0.0005) [28].
Our results also verified  that  age,  sex, initial BMI and percentage of EBWL  has no role in increasing risk of development of gall  stones.  which is similar to the results published by Igl�zias and colleague in 2003, in which out of  103 consecutive  RYGBP   patients,  88  had preoperative ultrasonographic evaluation of the remaining gall bladder, revealing that  19  had  already formed   biliary calculi (of which 11 had had past cholecystectomy and eight   underwent  cholecystectomy  during the RYGBP). The remaining 69 did not have ultrasonographic evidence of preoperative gall bladder disease.  Only 36   of   the   69 operated patients   who   did   not reveal   the   presence   of gall bladder   disease   during surgery   permitted   gall bladder investigation during the following 12 months. Comparison of the postoperative group forming calculi  (n=19) with the non-forming   group   (n=17)found  no  evidence  that  calculus formation  during  rapid   postoperative  weight  loss  is associated with  sex(P=0.4554).  age  (P=1.00);  preoperative BMI (P=0.3107),    percent   of  preoperative excess   weight (P=0.4970) and  percentage of EBWL (P=0.6902)in  the  first  postoperative year [29].
Conclusion: using UDCA for 6 months after LSG in morbid obese patients significantly reduces gall bladder stone formation. Longer interval therapy needs further studying.
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