Surg Endosc DOI 10.1007/s00464-015-4262-2
and Other Interventional Techniques
The impact of laparoscopic sleeve gastrectomy on weight loss and obesity-associated comorbidities: the results of 3 years of follow-up Konstantinos Albanopoulos1 • Dimitrios Tsamis1 • Maria Natoudi1 Leonidas Alevizos1 • Georgios Zografos1 • Emmanouil Leandros1
•
Received: 20 February 2015 / Accepted: 19 May 2015 Ó Springer Science+Business Media New York 2015
Abstract Background Laparoscopic sleeve gastrectomy is one of the most recent advances in the surgical treatment of morbid obesity. Extended follow-up studies of large cohorts are needed to establish the usefulness of the operation. The objectives of this study are to delineate the role of sleeve gastrectomy in weight loss and in comorbidities among obese patients. Methods Patients who underwent laparoscopic sleeve gastrectomy in a single bariatric center were followed up for a 3-year period. Weight loss and status of several comorbidities were assessed at the 1st, 3rd, 6th, 12th, 18th, 24th, and 36th postoperative month. Results Overall, after 3 years of follow-up of 88 patients, the mean body mass index (BMI) of the patients was 29.8 kg/ m2 (SD ±6.1), the % total weight loss was 38.1 % (SD ±12.9), the % excess weight loss was 69.5 % (SD ±17.5), and the % estimated BMI loss was 81.4 % (SD ±22.3). These parameters changed significantly over the first year of follow-up (p \ 0.001) and subsequently stabilized. The percentages of patients with hypertension (33.3 %), hyperlipidemia (26.4 %), diabetes mellitus (20.7 %), obstructive sleep apnea (20.2 %), and gastroesophageal reflux disease (GERD-27 %) were significantly reduced (10.5, 9.2, 1.1, 1.1, and 9.2 % respectively at 36 months postoperation), while 10 new cases of GERD appeared postoperatively. However, only three of the new GERD cases required medication, and only one of them experienced symptoms that persisted after the 3-year period.
Conclusion Three years of close follow-up of patients who had undergone laparoscopic sleeve gastrectomy demonstrated satisfactory weight loss results. Promising results were also obtained regarding various comorbidities of obese patients. Longer follow-up studies for more patients are needed to delineate the exact role of sleeve gastrectomy on postoperative outcomes.
& Dimitrios Tsamis [email protected]
Patients and methods
1
Laparoscopic Surgery Department, A 9 Propaideutic Surgical Clinic, Hippokration Hospital of Athens, University of Athens, Vas. Sofias 114, 11527 Athens, Greece
Keywords Sleeve gastrectomy Obesity Diabetes mellitus Hypertension Hyperlipidemia Sleep apnea Gastroesophageal reflux disease It has been approximately 10 years since sleeve gastrectomy was first performed laparoscopically [1]. Even today, this operation is gaining popularity because of its simple methodology and the low technical demands. This operation is a first-line solution in the worldwide obesity epidemic and is a reasonable alternative of laparoscopic gastric bypass [2]. The initial concerns regarding the complications of the method have been dissuaded. Unfortunately, there are few reports in the literature regarding the long-term results of this method [3–5]. In this study, 3-year follow-up results are presented regarding complications, weight loss, hyperlipidemia, hypertension, type 2 diabetes mellitus, obstructive sleep apnea, and gastroesophageal reflux disease in obese patients who underwent laparoscopic sleeve gastrectomy (LSG) in a single bariatric institution.
This study is a retrospective analysis of a prospective cohort of consecutive patients who underwent LSG for morbid obesity. All of the patients received operations in a
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single institution from the same minimally invasive experienced surgical team. The sleeve gastrectomies were performed by laparoscopy using four trocars. In all cases, staple lines were performed on a bougie size 34 fr that was placed in the stomach. After the operation, nasogastric tubes were placed, and methylene blue was instilled to ascertain the integrity of the stomach. The patients were evaluated and followed up for up to 3 years. This study was approved by the Ethical Committee of the local institution.
Operative technique The patient was positioned in supine position, with the legs apart, in a slight reverse Trendelenburg position. The pneumoperitoneum was established with open technique, and four trocars were placed. The greater omentum was freed from the greater curvature of stomach from a point 3–4 cm above pylorus through the angle of His. This maneuver was accomplished with the aid of an ultrasonic laparoscopic coagulation shear. A bougie was placed to guide the gastric section. The vertical section of the stomach was performed with two firings of laparoscopic linear stapler with green loads and subsequently firings with blue cartridges. All the firings were performed in close proximity with bougie. Specifically, all the morbidly obese patients who fulfilled the criteria for bariatric operation were questioned regarding their previous medical histories, comorbidities, and medications. Prior to the operation, blood tests were performed to evaluate patients’ lipidemic profiles and glucose levels. The total cholesterol and low-density cholesterol (LDL) levels were measured. Hyperlipidemia was defined by total cholesterol levels above 200 mg/dl and/or LDL levels above 190 mg/dl. Moreover, glucose tolerance tests were performed in all patients. Diabetes was defined by abnormal glucose tolerance tests and elevated glucose fasting levels ([110 mg/dl). The blood pressure in all patients was measured. Hypertension was defined by blood pressure exceeding 140 mmHg. In cases of elevated blood lipids, glucose or blood pressure without previous history or medication, the patients were evaluated by cardiologists. The medical team asked obese patients and family members about symptoms of obstructive sleep apnea. If a patient had any symptoms, such as repetitive pauses in breathing during sleep, intense snoring, or daytime sleepiness, he was evaluated by sleep apnea experts. Patients were also assessed for symptoms or medication for gastroesophageal reflux disease (GERD). In patients with symptoms of heartburn or regurgitation without medication more than two times per week, an upper endoscopy was performed. The presence of esophagitis confirmed the
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diagnosis. Nevertheless, the surgical team suggested performing upper endoscopy to all obese subjects, with or without having reflux symptoms. The patients were followed up at 1, 3, 12, 18, 24 and 36 months after the operation. In these time periods, the medical team assessed body mass index (BMI) and calculated the percentage of total weight loss (%TWL), the percentage of excess weight loss (%EWL), and the percentage of excess body mass index loss (%EBMIL). The %EWL was calculated as: preoperative body weight
current body weight
=preoperative body weight
ideal body weight
The ideal body weight (IBW) in kg was estimated: Males: IBW = 50 kg ? 2.3 kg for each 2.54 cm over 152.4 cm. Females: IBW = 45.5 kg ? 2.3 kg for each 2.54 cm over 152.4 cm. The research teams also repeated the questions regarding sleep apnea and gastroesophageal reflux symptoms and also asked about possible alterations of blood pressure, diabetes mellitus, hyperlipidemia, and gastroesophageal reflux disease medications. The remission of these comorbidities was accepted when the patients returned within the normal values (blood pressure \ 140 mmHg, total cholesterol \ 200 mg/dl, LDL \ 190 mg/dl, fasting glucose \ 110 mg/dl). Additionally, the intraoperative and postoperative complications of LSG, the hospital stay, and reoperations or readmissions were recorded. All of the aforementioned data were gathered prospectively by means of a standardized protocol and a computer database. The authors desired a complete follow-up study having the patients assessed closely only from the study members. By this way, the curve of the results of body weight loss and comorbidities through the time can be better delineated. Follow-up of the patients reached 99 %. Statistical analysis was performed retrospectively using the SPSS 18.0 (SPSS IncÒ, Chicago, IL) statistical software. Quantitative data were expressed as either mean (±SD) or median and range. Differences were analyzed by the Wilcoxon’s test or Chi-square test. Significance was tested at the 5 % level of statistical significance (p \ 0.05).
Results Overall, 88 patients underwent LSG for morbid obesity and completed follow-up at the 1st, 3rd, 6th, 12th, 18th, 24th, and 36th postoperative month in our institution from March of 2008 until March of 2013. The general characteristics of these 88 patients are depicted in Table 1. Over half (64 %)
Surg Endosc Table 1 General characteristics of the patients who were followed up consistently after LSG No of patients n = 88
Table 2 Evaluation of weight loss by terms of BMI, %TWL, %EWL, and %EBMIL after LSG in 88 patients with a 3-year followupà BMI (kg/m2)
%TWL
%EWL
%EBMIL
Sex (n) Men
32 (36 %)
Preoperative
47.8 (6.9)
–
–
–
42.5 (6.1)
12.0 (5.1)
21.0 (6.5)
24.5 (8.3)
57 (64 %)
1 month
Age (years)
39.2 (range 18–64)
Height (m)
1.70 (range 1.52–1.97)
3 months 6 months
38.1 (6.2) 34.5 (6.1)
20.6 (6.2) 27.9 (8.1)
37.9 (10.1) 52.6 (13.5)
44.4 (13.2) 61.8 (18.4)
139.3 (range 98–210)
12 months
30.9 (5.9)
35.7 (10.9)
66.1 (16.8)
77.7 (22.1)
47.8 (range 35.2–70.9) 8 (9.0 %)
18 months
29.5 (5.6)
38.9 (12.1)
70.6 (17.2)
83.1 (22.5)
24 months
29.4 (5.8)
39.1 (13.5)
70.5 (16.8)
82.8 (21.7)
3 (3.3 %)
36 months
29.8 (6.1)
38.1 (12.9)
69.5 (17.4)
81.4 (22.3)
Leak
1 (1.1 %)
à
Abscess
1 (1.1 %)
Bleeding
1 (1.1 %)
BMI body mass index, TWL total weight loss, EWL excessive weight loss, EBMIL excessive body mass index loss
Female
Weight (kg) 2
BMI (kg/m ) Postoperative complications (total-n) Major complications (n)
Minor complications (n)
5 (5.7 %)
Thrombophlebitis
1 (1.1 %)
Atelectasia/pneumonia
1 (1.1 %)
Fever
Values are expressed as mean (SD)
3 (3.3 %)
Reoperations (n)
2 (2.2 %)
Mortality (n)
0 (0 %)
BMI body mass index Data are expressed as mean or in percent
of the patients were women, and the rest (36 %) were men. Their mean age was 39.2 years (range 18–64), and their mean BMI was 47.8 kg/m2. Postoperative complications were present in eight patients (9.0 %). The most common major complications were bleeding (n = 1, 1.1 %), leak (n = 1, 1.1 %), and abscess formation (n = 1, 1.1 %). Other complications included fever (n = 3, 3.3 %), atelectasia/pneumonia (n = 1, 1.1 %), and thrombophlebitis (n = 1, 1.1 %). Reoperations were performed in two cases because of postoperative bleeding (one patient) and leakage (one patient). During these 5 years, no death was recorded. BMI, %TWL, %EWL, and %EBMIL over the 3-year follow-up are presented in Table 2. These parameters changed significantly over the first year of followup (p \ 0.001) and subsequently stabilized, as shown in Fig. 1. The first year after the LSG, 1.3 % of patients presented with an EWL \ 25 %, 15.8 % with an EWL between 25 and 50 %, and the majority (82.9 %) with an EWL [ 50 %. At the second year of postoperative followup, the percentage of patients with a EWL \ 25 % remained unaltered, while the percentage of patients with a EWL between 25 and 50 % slightly decreased to 9.8 %, and the percentage of patients with EWL [ 50 % slightly increased to 88.9 %. These percentages remained the same in the third postoperative year. Overall, at 36 months of follow-up, the mean BMI of the patients was 29.8 kg/m2,
%TWL was 38.1 %, %EWL was 69.5 %, and the %EBMIL was 81.4 %. The presence of hypertension, hyperlipidemia, diabetes mellitus, obstructive sleep apnea, and GERD in these obese patients preoperative and during follow-up is presented in Table 3. Overall, 29 people had initially increased blood pressure, and 26 of them required antihypertensive medication. Twenty-two of them (75.8 %) returned gradually to normal blood pressure (p = 0.01). In half of these patients (n = 11), normalization of blood pressure was observed during the first 3 months of follow-up. Failure to cure hypertension after LSG was more frequently observed in patients aged [50 years (p = 0.01). Twenty-three patients presented with hyperlipidemia preoperatively. Postoperatively, serum lipid levels gradually returned to normal levels in 12 of them (p = 0.01) and in the vast majority over the first 6 months (11 patients). Moreover, lipid serum levels were postoperatively reduced in three patients without reaching normal levels, and four new cases of hyperlipidemia appeared after the first year in patients who did not have hyperlipidemia preoperatively. Eighteen patients presented preoperatively with diabetes mellitus, and all of them were under anti-diabetic medication. Blood glucose levels returned to normal values in 17 of them after LSG, and those patients stopped receiving medication (p \ 0.001). Among six of these patients, the normalization of glucose levels was recorded by the first postoperative month. The eighteenth patient did not become normoglycemic over the 3-year follow-up but was able to reduce medication. Overall, 18 patients presented with obstructive sleep apnea, and 11 of them with a severe form requiring continuous positive airway pressure (CPAP) breathing therapy. One month later, the number of patients with obstructive sleep apnea symptoms was significantly reduced (p \ 0.001). All
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patients with obstructive sleep apnea who did not use CPAP (n = 7) stopped presenting any symptoms, while only one CPAP patient continued using it. Twenty-four patients had symptoms of GERD preoperatively and concomitant esophagitis that was controlled with medication. In most of these patients (n = 20), GERD symptoms stopped after the LSG and patients discontinued medication (p = 0.001). Among cured patients, the majority were free of symptoms by the third postoperative month (n = 14). However, four of them started taking medications again after the second year of follow-up. Interestingly, none of the patients who were cured by the first month had relapse during the 3 years of follow-up, but this observation was not statistically significant (p = 0.06). GERD was the only disorder which appeared in a portion of patients postoperatively. Overall, ten patients without any preoperative symptom presented with GERD after LSG. However, only three of these patients needed a medication, and only one patient experienced symptoms that persisted after the 3-year period, and even in this patient, medication was discontinued after the second year. The latter patient had undergone again upper gastrointestinal endoscopy at 1 year after operation and mild esophagitis was present.
Discussion
Fig. 1 Body mass index (BMI), % total weight loss (%TWL), % excessive weight loss (%EWL), and % excessive body mass index loss (%EBMIL) during the follow-up time points
Laparoscopic sleeve gastrectomy is the most recently developed operation for the treatment of morbid obesity, being no more than 10 years old [1]. In the modern era, the prevalence of morbid obesity is growing in many countries worldwide, including Greece. This led to the need to develop an easy operative procedure, with few technical demands and few complications that was easily accepted by patients, with an adequate, quick, and durable result in body weight loss [6]. This operation also needed to have
Table 3 Alterations in percentages of various comorbidities in 88 patients after LSG with a 3-year follow-up Hypertension (%)
Hyperlipidemia (%)
Diabetes mellitus (%)
Obstructive sleep apnea (%)
GERD (%)
Preoperative
33.3
26.4
20.7
20.2
27
1 month
18.3
17.2
10.3
1.1
26.1
3 months
14.9
16.1
6.9
1.1
20.5
6 months
16.1
17.2
3.4
1.1
13.6
12 months
15.1
17.2
3.4
1.1
8
24 months
9.3
9.2
0
1.1
6.1
36 months
10.5
9.2
1.1
1.1
9.2
GERD gastroesophageal reflux disease
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the capability to control all the obesity-derived comorbidities, such as diabetes mellitus. Laparoscopic sleeve gastrectomy is a restrictive operation with a propensity to change some hormonal signals [7]. This operation has no foreign body insertion, such as laparoscopic adjustable gastric band or vertical gastroplasty, and avoids disadvantages of more malabsorptive operations, such as gastric bypass, which excessively restricts food intake, causing dumping syndrome and diarrhea. Furthermore, the disadvantages of gastric bypass include more complications compared with the rest of the bariatric procedures and unproved durability [6–9]. Even now, there is a lack of sufficient data and studies regarding the weight loss succeeded in time and the impact of this operation on certain comorbidities, such as GERD, obstructive sleep apnea, hyperlipidemia, diabetes mellitus, and hypertension. In this study, the medical team of the endoscopic surgical department captured data from patients who underwent LSG and enrolled them in a close follow-up program, assessing several comorbidities and weight loss. The patients lived all over the country, so follow-up was not easy. This study included only the patients capable of long-time follow-up. The rate of complications due to the procedure in this study is 9 %. The most common major complications are the staple line leakage and hemorrhage. In this cohort, the prevalence of these two complications is 1.1 and 1.1 %, respectively. Although these complications could prove fatal, no mortality occurred in this cohort. Even though it is possible that during the 5-year study period, the surgery team become more experienced, there was no overall difference in the midterm outcomes. In other cohorts and review studies, the morbidity of the procedure ranged from 0 to 24 %. In previously published studies, leakage and hemorrhage were reported to occur in 1–6 % and 2–7.3 % of cases, respectively [10–12]. As in other bariatric centers, blue dye and upper gastrointestinal transit with water soluble contrast in the postoperative period were used to diagnose a staple line leak. Imaging studies and computed tomography scans were the main method of diagnosing and treating abscesses and fluid collections. The leaks and hemorrhages that required treatment by a second operation occurred in two cases (2.2 %). In the first case, total gastrectomy was performed because the leak developed to gastrobronchial fistula [13]. The mean BMI of the patients preoperatively was 47.8 kg/m2. In the first year after the operation, mean BMI was 30.9 kg/m2; in the second year, it was 29.4 kg/m2, and in the third year it was 29.8 kg/m2. Most of the loss of weight was achieved in the first year, especially during the first 6 months. After the second year, the patients keep
steady their body weight, and no further loss is achieved. The same result is better shown using the %EBMIL, which was 77.7 % at the first year, 82.8 % at the second year, and 81.4 % at the third year postoperatively. In our cohort, the body weight loss is not associated with the age, sex, or preoperative BMI of the patient. In other published series, %EWL in 1 year is 46–83.3 %, but in 3 years, it is less (55–66 %), revealing that after the second year, the weight loss plateaued and no further loss was achieved [1, 7, 8, 11–17]. Individual studies with 5 years of follow-up reveal a %EBMIL of 37.2–40.3 % [4, 9, 18, 19]. These results reveal that the weight loss after the LSG is achieved early during the first and second year, and weight regain is noticed thereafter. Few studies exist with long-term follow-up of patients after this operation. In these studies, the number of patients is small, and a stable %EWL is recorded (68 %) after 8 years of follow-up [3, 11]. This %EWL result raises questions about the durability of the method, and a longer follow-up of our patients is ongoing. Laparoscopic sleeve gastrectomy also has a great impact on several comorbidities of morbid obesity. Several studies assessed these comorbidities after LSG, but in most of them, the follow-up time period is 12–24 months. All of these studies exhibit improvement in hypertension, diabetes mellitus, hyperlipidemia, sleep apnea, and GERD after LSG [10]. Specifically, in various published series, hypertension is resolved after LSG in 62.5–93 % of cases after 6–18 months of follow-up [8, 13, 20]. In our cohort, 75.8 % of patients with hypertension stopped medication gradually during 36 months of follow-up, and improvement was recorded in one patient, who reduced his medication. Failure to relieve blood hypertension after the LSG was associated with advanced patient age ([50 years old, p = 0.01). Hyperlipidemia in published series by Cottam et al. and Han et al. was resolved in 73 and 45 %, respectively, after 1 year of follow-up after LSG. Improvement in hyperlipidemia was observed in the same studies in 5 and 30 %, respectively [8, 10, 14]. In our study, the resolution of hyperlipidemia was observed in 52.17 % of cases, and the effects of surgery and the alteration of the postoperative diet on lipid levels were mainly observed during the first 6 months after the operation. Improvement in the serum lipid levels was observed in three patients during the 3 years of follow-up. Interestingly, four patients without high lipid serum values before the LSG later developed hyperlipidemia after the operation and thereafter received medication. It is our estimation that these new cases of hyperlipidemia were not related to the previous bariatric operation. Many studies have been published about the efficacy of LSG in improving diabetes mellitus and glucose levels [8,
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10, 14, 20, 22–24]. In several studies, the resolution or improvement in diabetes mellitus is reaching 100 % postoperatively after LSG, especially after 1 year [10, 14]. This effect is attributed to lower ghrelin levels and increased concentrations of cholecystokinin, glucagon-like peptide 1, and peptide YY [7, 21]. Recurrences of type 2 diabetes mellitus are found in approximately 12 % of cases [9]. In our study, 94.4 % of patients did not need any medication within 36 months postoperation, and the remaining 5.6 % (one patient) reduced the amount of drugs taken. It is well-known that there is a strong relationship between obesity and obstructive sleep apnea [25]. In general, all bariatric operations improve sleep apnea in 75 % of cases as described in a recent review from Sarkhosh et al. [26] which included 69 studies with 13,900 patients. Prior to the LSG, 20.2 % of the patients in our study suffered from obstructive sleep apnea. An impressive profound effect on sleep apnea was achieved in the first month postoperatively. Only one patient did not improve after LSG, and the same patient was using a CPAP mask after 3 years of follow-up. The relationship between LSG and GERD is not straightforward. In our study, 83.3 % of the patients who had preoperative GERD were cured at 24 months postoperation. After 2 years, four patients started having symptoms again and started medication again. Moreover, 10 patients who did not preoperatively have symptoms of GERD started having symptoms in the postoperative period. However, GERD in these patients seemed to be selfcontrollable, and medication was taken temporarily only in three cases. Similar results were published by Sieber et al., where LSG led to the remission of GERD in 47.4 % of patients, but new onset GERD was diagnosed in 22 % of patients [9]. Similar results were also published by Rawlins et al. [27]. The same results from more than one study suggest that LSG has no clear effect on gastroesophageal reflux. This operation could cause damage to the anatomy of the gastroesophageal region and angle of His, making it susceptible to GERD. In conclusion, this study provides a clear view of the benefits of LSG. Close follow-up of 88 patients revealed a satisfactory result in weight loss. Recent large meta-analyses and reviews have shown that weight loss and diabetes remission are greatest and last longer in patients undergoing biliopancreatic diversion and gastric bypass [28]. But sleeve gastrectomy also provides satisfactory results. The stabilization of body mass at the third year postoperatively necessitates the close follow-up of these patients for an extended time period to ascertain the durability of the method. Promising results were also recognized in various comorbidities of obese patients, such as hypertension, hyperlipidemia, diabetes mellitus type 2, and obstructive sleep apnea. The same positive results were not realized for
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the comorbidity of gastroesophageal reflux, for which LSG seemed to both precipitate and ameliorate symptoms. Extended follow-up time is warranted to clarify the relationship between this operation and the GERD. Disclosures Konstantinos Albanopoulos, Dimitrios Tsamis, Maria Natoudi, Leonidas Alevizos, Georgios Zografos, Emmanouil Leandros have no conflicts of interest or financial ties to disclose.
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and Other Interventional Techniques
The impact of laparoscopic sleeve gastrectomy on weight loss and obesity-associated comorbidities: the results of 3 years of follow-up Konstantinos Albanopoulos1 • Dimitrios Tsamis1 • Maria Natoudi1 Leonidas Alevizos1 • Georgios Zografos1 • Emmanouil Leandros1
•
Received: 20 February 2015 / Accepted: 19 May 2015 Ó Springer Science+Business Media New York 2015
Abstract Background Laparoscopic sleeve gastrectomy is one of the most recent advances in the surgical treatment of morbid obesity. Extended follow-up studies of large cohorts are needed to establish the usefulness of the operation. The objectives of this study are to delineate the role of sleeve gastrectomy in weight loss and in comorbidities among obese patients. Methods Patients who underwent laparoscopic sleeve gastrectomy in a single bariatric center were followed up for a 3-year period. Weight loss and status of several comorbidities were assessed at the 1st, 3rd, 6th, 12th, 18th, 24th, and 36th postoperative month. Results Overall, after 3 years of follow-up of 88 patients, the mean body mass index (BMI) of the patients was 29.8 kg/ m2 (SD ±6.1), the % total weight loss was 38.1 % (SD ±12.9), the % excess weight loss was 69.5 % (SD ±17.5), and the % estimated BMI loss was 81.4 % (SD ±22.3). These parameters changed significantly over the first year of follow-up (p \ 0.001) and subsequently stabilized. The percentages of patients with hypertension (33.3 %), hyperlipidemia (26.4 %), diabetes mellitus (20.7 %), obstructive sleep apnea (20.2 %), and gastroesophageal reflux disease (GERD-27 %) were significantly reduced (10.5, 9.2, 1.1, 1.1, and 9.2 % respectively at 36 months postoperation), while 10 new cases of GERD appeared postoperatively. However, only three of the new GERD cases required medication, and only one of them experienced symptoms that persisted after the 3-year period.
Conclusion Three years of close follow-up of patients who had undergone laparoscopic sleeve gastrectomy demonstrated satisfactory weight loss results. Promising results were also obtained regarding various comorbidities of obese patients. Longer follow-up studies for more patients are needed to delineate the exact role of sleeve gastrectomy on postoperative outcomes.
& Dimitrios Tsamis [email protected]
Patients and methods
1
Laparoscopic Surgery Department, A 9 Propaideutic Surgical Clinic, Hippokration Hospital of Athens, University of Athens, Vas. Sofias 114, 11527 Athens, Greece
Keywords Sleeve gastrectomy Obesity Diabetes mellitus Hypertension Hyperlipidemia Sleep apnea Gastroesophageal reflux disease It has been approximately 10 years since sleeve gastrectomy was first performed laparoscopically [1]. Even today, this operation is gaining popularity because of its simple methodology and the low technical demands. This operation is a first-line solution in the worldwide obesity epidemic and is a reasonable alternative of laparoscopic gastric bypass [2]. The initial concerns regarding the complications of the method have been dissuaded. Unfortunately, there are few reports in the literature regarding the long-term results of this method [3–5]. In this study, 3-year follow-up results are presented regarding complications, weight loss, hyperlipidemia, hypertension, type 2 diabetes mellitus, obstructive sleep apnea, and gastroesophageal reflux disease in obese patients who underwent laparoscopic sleeve gastrectomy (LSG) in a single bariatric institution.
This study is a retrospective analysis of a prospective cohort of consecutive patients who underwent LSG for morbid obesity. All of the patients received operations in a
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single institution from the same minimally invasive experienced surgical team. The sleeve gastrectomies were performed by laparoscopy using four trocars. In all cases, staple lines were performed on a bougie size 34 fr that was placed in the stomach. After the operation, nasogastric tubes were placed, and methylene blue was instilled to ascertain the integrity of the stomach. The patients were evaluated and followed up for up to 3 years. This study was approved by the Ethical Committee of the local institution.
Operative technique The patient was positioned in supine position, with the legs apart, in a slight reverse Trendelenburg position. The pneumoperitoneum was established with open technique, and four trocars were placed. The greater omentum was freed from the greater curvature of stomach from a point 3–4 cm above pylorus through the angle of His. This maneuver was accomplished with the aid of an ultrasonic laparoscopic coagulation shear. A bougie was placed to guide the gastric section. The vertical section of the stomach was performed with two firings of laparoscopic linear stapler with green loads and subsequently firings with blue cartridges. All the firings were performed in close proximity with bougie. Specifically, all the morbidly obese patients who fulfilled the criteria for bariatric operation were questioned regarding their previous medical histories, comorbidities, and medications. Prior to the operation, blood tests were performed to evaluate patients’ lipidemic profiles and glucose levels. The total cholesterol and low-density cholesterol (LDL) levels were measured. Hyperlipidemia was defined by total cholesterol levels above 200 mg/dl and/or LDL levels above 190 mg/dl. Moreover, glucose tolerance tests were performed in all patients. Diabetes was defined by abnormal glucose tolerance tests and elevated glucose fasting levels ([110 mg/dl). The blood pressure in all patients was measured. Hypertension was defined by blood pressure exceeding 140 mmHg. In cases of elevated blood lipids, glucose or blood pressure without previous history or medication, the patients were evaluated by cardiologists. The medical team asked obese patients and family members about symptoms of obstructive sleep apnea. If a patient had any symptoms, such as repetitive pauses in breathing during sleep, intense snoring, or daytime sleepiness, he was evaluated by sleep apnea experts. Patients were also assessed for symptoms or medication for gastroesophageal reflux disease (GERD). In patients with symptoms of heartburn or regurgitation without medication more than two times per week, an upper endoscopy was performed. The presence of esophagitis confirmed the
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diagnosis. Nevertheless, the surgical team suggested performing upper endoscopy to all obese subjects, with or without having reflux symptoms. The patients were followed up at 1, 3, 12, 18, 24 and 36 months after the operation. In these time periods, the medical team assessed body mass index (BMI) and calculated the percentage of total weight loss (%TWL), the percentage of excess weight loss (%EWL), and the percentage of excess body mass index loss (%EBMIL). The %EWL was calculated as: preoperative body weight
current body weight
=preoperative body weight
ideal body weight
The ideal body weight (IBW) in kg was estimated: Males: IBW = 50 kg ? 2.3 kg for each 2.54 cm over 152.4 cm. Females: IBW = 45.5 kg ? 2.3 kg for each 2.54 cm over 152.4 cm. The research teams also repeated the questions regarding sleep apnea and gastroesophageal reflux symptoms and also asked about possible alterations of blood pressure, diabetes mellitus, hyperlipidemia, and gastroesophageal reflux disease medications. The remission of these comorbidities was accepted when the patients returned within the normal values (blood pressure \ 140 mmHg, total cholesterol \ 200 mg/dl, LDL \ 190 mg/dl, fasting glucose \ 110 mg/dl). Additionally, the intraoperative and postoperative complications of LSG, the hospital stay, and reoperations or readmissions were recorded. All of the aforementioned data were gathered prospectively by means of a standardized protocol and a computer database. The authors desired a complete follow-up study having the patients assessed closely only from the study members. By this way, the curve of the results of body weight loss and comorbidities through the time can be better delineated. Follow-up of the patients reached 99 %. Statistical analysis was performed retrospectively using the SPSS 18.0 (SPSS IncÒ, Chicago, IL) statistical software. Quantitative data were expressed as either mean (±SD) or median and range. Differences were analyzed by the Wilcoxon’s test or Chi-square test. Significance was tested at the 5 % level of statistical significance (p \ 0.05).
Results Overall, 88 patients underwent LSG for morbid obesity and completed follow-up at the 1st, 3rd, 6th, 12th, 18th, 24th, and 36th postoperative month in our institution from March of 2008 until March of 2013. The general characteristics of these 88 patients are depicted in Table 1. Over half (64 %)
Surg Endosc Table 1 General characteristics of the patients who were followed up consistently after LSG No of patients n = 88
Table 2 Evaluation of weight loss by terms of BMI, %TWL, %EWL, and %EBMIL after LSG in 88 patients with a 3-year followupà BMI (kg/m2)
%TWL
%EWL
%EBMIL
Sex (n) Men
32 (36 %)
Preoperative
47.8 (6.9)
–
–
–
42.5 (6.1)
12.0 (5.1)
21.0 (6.5)
24.5 (8.3)
57 (64 %)
1 month
Age (years)
39.2 (range 18–64)
Height (m)
1.70 (range 1.52–1.97)
3 months 6 months
38.1 (6.2) 34.5 (6.1)
20.6 (6.2) 27.9 (8.1)
37.9 (10.1) 52.6 (13.5)
44.4 (13.2) 61.8 (18.4)
139.3 (range 98–210)
12 months
30.9 (5.9)
35.7 (10.9)
66.1 (16.8)
77.7 (22.1)
47.8 (range 35.2–70.9) 8 (9.0 %)
18 months
29.5 (5.6)
38.9 (12.1)
70.6 (17.2)
83.1 (22.5)
24 months
29.4 (5.8)
39.1 (13.5)
70.5 (16.8)
82.8 (21.7)
3 (3.3 %)
36 months
29.8 (6.1)
38.1 (12.9)
69.5 (17.4)
81.4 (22.3)
Leak
1 (1.1 %)
à
Abscess
1 (1.1 %)
Bleeding
1 (1.1 %)
BMI body mass index, TWL total weight loss, EWL excessive weight loss, EBMIL excessive body mass index loss
Female
Weight (kg) 2
BMI (kg/m ) Postoperative complications (total-n) Major complications (n)
Minor complications (n)
5 (5.7 %)
Thrombophlebitis
1 (1.1 %)
Atelectasia/pneumonia
1 (1.1 %)
Fever
Values are expressed as mean (SD)
3 (3.3 %)
Reoperations (n)
2 (2.2 %)
Mortality (n)
0 (0 %)
BMI body mass index Data are expressed as mean or in percent
of the patients were women, and the rest (36 %) were men. Their mean age was 39.2 years (range 18–64), and their mean BMI was 47.8 kg/m2. Postoperative complications were present in eight patients (9.0 %). The most common major complications were bleeding (n = 1, 1.1 %), leak (n = 1, 1.1 %), and abscess formation (n = 1, 1.1 %). Other complications included fever (n = 3, 3.3 %), atelectasia/pneumonia (n = 1, 1.1 %), and thrombophlebitis (n = 1, 1.1 %). Reoperations were performed in two cases because of postoperative bleeding (one patient) and leakage (one patient). During these 5 years, no death was recorded. BMI, %TWL, %EWL, and %EBMIL over the 3-year follow-up are presented in Table 2. These parameters changed significantly over the first year of followup (p \ 0.001) and subsequently stabilized, as shown in Fig. 1. The first year after the LSG, 1.3 % of patients presented with an EWL \ 25 %, 15.8 % with an EWL between 25 and 50 %, and the majority (82.9 %) with an EWL [ 50 %. At the second year of postoperative followup, the percentage of patients with a EWL \ 25 % remained unaltered, while the percentage of patients with a EWL between 25 and 50 % slightly decreased to 9.8 %, and the percentage of patients with EWL [ 50 % slightly increased to 88.9 %. These percentages remained the same in the third postoperative year. Overall, at 36 months of follow-up, the mean BMI of the patients was 29.8 kg/m2,
%TWL was 38.1 %, %EWL was 69.5 %, and the %EBMIL was 81.4 %. The presence of hypertension, hyperlipidemia, diabetes mellitus, obstructive sleep apnea, and GERD in these obese patients preoperative and during follow-up is presented in Table 3. Overall, 29 people had initially increased blood pressure, and 26 of them required antihypertensive medication. Twenty-two of them (75.8 %) returned gradually to normal blood pressure (p = 0.01). In half of these patients (n = 11), normalization of blood pressure was observed during the first 3 months of follow-up. Failure to cure hypertension after LSG was more frequently observed in patients aged [50 years (p = 0.01). Twenty-three patients presented with hyperlipidemia preoperatively. Postoperatively, serum lipid levels gradually returned to normal levels in 12 of them (p = 0.01) and in the vast majority over the first 6 months (11 patients). Moreover, lipid serum levels were postoperatively reduced in three patients without reaching normal levels, and four new cases of hyperlipidemia appeared after the first year in patients who did not have hyperlipidemia preoperatively. Eighteen patients presented preoperatively with diabetes mellitus, and all of them were under anti-diabetic medication. Blood glucose levels returned to normal values in 17 of them after LSG, and those patients stopped receiving medication (p \ 0.001). Among six of these patients, the normalization of glucose levels was recorded by the first postoperative month. The eighteenth patient did not become normoglycemic over the 3-year follow-up but was able to reduce medication. Overall, 18 patients presented with obstructive sleep apnea, and 11 of them with a severe form requiring continuous positive airway pressure (CPAP) breathing therapy. One month later, the number of patients with obstructive sleep apnea symptoms was significantly reduced (p \ 0.001). All
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patients with obstructive sleep apnea who did not use CPAP (n = 7) stopped presenting any symptoms, while only one CPAP patient continued using it. Twenty-four patients had symptoms of GERD preoperatively and concomitant esophagitis that was controlled with medication. In most of these patients (n = 20), GERD symptoms stopped after the LSG and patients discontinued medication (p = 0.001). Among cured patients, the majority were free of symptoms by the third postoperative month (n = 14). However, four of them started taking medications again after the second year of follow-up. Interestingly, none of the patients who were cured by the first month had relapse during the 3 years of follow-up, but this observation was not statistically significant (p = 0.06). GERD was the only disorder which appeared in a portion of patients postoperatively. Overall, ten patients without any preoperative symptom presented with GERD after LSG. However, only three of these patients needed a medication, and only one patient experienced symptoms that persisted after the 3-year period, and even in this patient, medication was discontinued after the second year. The latter patient had undergone again upper gastrointestinal endoscopy at 1 year after operation and mild esophagitis was present.
Discussion
Fig. 1 Body mass index (BMI), % total weight loss (%TWL), % excessive weight loss (%EWL), and % excessive body mass index loss (%EBMIL) during the follow-up time points
Laparoscopic sleeve gastrectomy is the most recently developed operation for the treatment of morbid obesity, being no more than 10 years old [1]. In the modern era, the prevalence of morbid obesity is growing in many countries worldwide, including Greece. This led to the need to develop an easy operative procedure, with few technical demands and few complications that was easily accepted by patients, with an adequate, quick, and durable result in body weight loss [6]. This operation also needed to have
Table 3 Alterations in percentages of various comorbidities in 88 patients after LSG with a 3-year follow-up Hypertension (%)
Hyperlipidemia (%)
Diabetes mellitus (%)
Obstructive sleep apnea (%)
GERD (%)
Preoperative
33.3
26.4
20.7
20.2
27
1 month
18.3
17.2
10.3
1.1
26.1
3 months
14.9
16.1
6.9
1.1
20.5
6 months
16.1
17.2
3.4
1.1
13.6
12 months
15.1
17.2
3.4
1.1
8
24 months
9.3
9.2
0
1.1
6.1
36 months
10.5
9.2
1.1
1.1
9.2
GERD gastroesophageal reflux disease
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the capability to control all the obesity-derived comorbidities, such as diabetes mellitus. Laparoscopic sleeve gastrectomy is a restrictive operation with a propensity to change some hormonal signals [7]. This operation has no foreign body insertion, such as laparoscopic adjustable gastric band or vertical gastroplasty, and avoids disadvantages of more malabsorptive operations, such as gastric bypass, which excessively restricts food intake, causing dumping syndrome and diarrhea. Furthermore, the disadvantages of gastric bypass include more complications compared with the rest of the bariatric procedures and unproved durability [6–9]. Even now, there is a lack of sufficient data and studies regarding the weight loss succeeded in time and the impact of this operation on certain comorbidities, such as GERD, obstructive sleep apnea, hyperlipidemia, diabetes mellitus, and hypertension. In this study, the medical team of the endoscopic surgical department captured data from patients who underwent LSG and enrolled them in a close follow-up program, assessing several comorbidities and weight loss. The patients lived all over the country, so follow-up was not easy. This study included only the patients capable of long-time follow-up. The rate of complications due to the procedure in this study is 9 %. The most common major complications are the staple line leakage and hemorrhage. In this cohort, the prevalence of these two complications is 1.1 and 1.1 %, respectively. Although these complications could prove fatal, no mortality occurred in this cohort. Even though it is possible that during the 5-year study period, the surgery team become more experienced, there was no overall difference in the midterm outcomes. In other cohorts and review studies, the morbidity of the procedure ranged from 0 to 24 %. In previously published studies, leakage and hemorrhage were reported to occur in 1–6 % and 2–7.3 % of cases, respectively [10–12]. As in other bariatric centers, blue dye and upper gastrointestinal transit with water soluble contrast in the postoperative period were used to diagnose a staple line leak. Imaging studies and computed tomography scans were the main method of diagnosing and treating abscesses and fluid collections. The leaks and hemorrhages that required treatment by a second operation occurred in two cases (2.2 %). In the first case, total gastrectomy was performed because the leak developed to gastrobronchial fistula [13]. The mean BMI of the patients preoperatively was 47.8 kg/m2. In the first year after the operation, mean BMI was 30.9 kg/m2; in the second year, it was 29.4 kg/m2, and in the third year it was 29.8 kg/m2. Most of the loss of weight was achieved in the first year, especially during the first 6 months. After the second year, the patients keep
steady their body weight, and no further loss is achieved. The same result is better shown using the %EBMIL, which was 77.7 % at the first year, 82.8 % at the second year, and 81.4 % at the third year postoperatively. In our cohort, the body weight loss is not associated with the age, sex, or preoperative BMI of the patient. In other published series, %EWL in 1 year is 46–83.3 %, but in 3 years, it is less (55–66 %), revealing that after the second year, the weight loss plateaued and no further loss was achieved [1, 7, 8, 11–17]. Individual studies with 5 years of follow-up reveal a %EBMIL of 37.2–40.3 % [4, 9, 18, 19]. These results reveal that the weight loss after the LSG is achieved early during the first and second year, and weight regain is noticed thereafter. Few studies exist with long-term follow-up of patients after this operation. In these studies, the number of patients is small, and a stable %EWL is recorded (68 %) after 8 years of follow-up [3, 11]. This %EWL result raises questions about the durability of the method, and a longer follow-up of our patients is ongoing. Laparoscopic sleeve gastrectomy also has a great impact on several comorbidities of morbid obesity. Several studies assessed these comorbidities after LSG, but in most of them, the follow-up time period is 12–24 months. All of these studies exhibit improvement in hypertension, diabetes mellitus, hyperlipidemia, sleep apnea, and GERD after LSG [10]. Specifically, in various published series, hypertension is resolved after LSG in 62.5–93 % of cases after 6–18 months of follow-up [8, 13, 20]. In our cohort, 75.8 % of patients with hypertension stopped medication gradually during 36 months of follow-up, and improvement was recorded in one patient, who reduced his medication. Failure to relieve blood hypertension after the LSG was associated with advanced patient age ([50 years old, p = 0.01). Hyperlipidemia in published series by Cottam et al. and Han et al. was resolved in 73 and 45 %, respectively, after 1 year of follow-up after LSG. Improvement in hyperlipidemia was observed in the same studies in 5 and 30 %, respectively [8, 10, 14]. In our study, the resolution of hyperlipidemia was observed in 52.17 % of cases, and the effects of surgery and the alteration of the postoperative diet on lipid levels were mainly observed during the first 6 months after the operation. Improvement in the serum lipid levels was observed in three patients during the 3 years of follow-up. Interestingly, four patients without high lipid serum values before the LSG later developed hyperlipidemia after the operation and thereafter received medication. It is our estimation that these new cases of hyperlipidemia were not related to the previous bariatric operation. Many studies have been published about the efficacy of LSG in improving diabetes mellitus and glucose levels [8,
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10, 14, 20, 22–24]. In several studies, the resolution or improvement in diabetes mellitus is reaching 100 % postoperatively after LSG, especially after 1 year [10, 14]. This effect is attributed to lower ghrelin levels and increased concentrations of cholecystokinin, glucagon-like peptide 1, and peptide YY [7, 21]. Recurrences of type 2 diabetes mellitus are found in approximately 12 % of cases [9]. In our study, 94.4 % of patients did not need any medication within 36 months postoperation, and the remaining 5.6 % (one patient) reduced the amount of drugs taken. It is well-known that there is a strong relationship between obesity and obstructive sleep apnea [25]. In general, all bariatric operations improve sleep apnea in 75 % of cases as described in a recent review from Sarkhosh et al. [26] which included 69 studies with 13,900 patients. Prior to the LSG, 20.2 % of the patients in our study suffered from obstructive sleep apnea. An impressive profound effect on sleep apnea was achieved in the first month postoperatively. Only one patient did not improve after LSG, and the same patient was using a CPAP mask after 3 years of follow-up. The relationship between LSG and GERD is not straightforward. In our study, 83.3 % of the patients who had preoperative GERD were cured at 24 months postoperation. After 2 years, four patients started having symptoms again and started medication again. Moreover, 10 patients who did not preoperatively have symptoms of GERD started having symptoms in the postoperative period. However, GERD in these patients seemed to be selfcontrollable, and medication was taken temporarily only in three cases. Similar results were published by Sieber et al., where LSG led to the remission of GERD in 47.4 % of patients, but new onset GERD was diagnosed in 22 % of patients [9]. Similar results were also published by Rawlins et al. [27]. The same results from more than one study suggest that LSG has no clear effect on gastroesophageal reflux. This operation could cause damage to the anatomy of the gastroesophageal region and angle of His, making it susceptible to GERD. In conclusion, this study provides a clear view of the benefits of LSG. Close follow-up of 88 patients revealed a satisfactory result in weight loss. Recent large meta-analyses and reviews have shown that weight loss and diabetes remission are greatest and last longer in patients undergoing biliopancreatic diversion and gastric bypass [28]. But sleeve gastrectomy also provides satisfactory results. The stabilization of body mass at the third year postoperatively necessitates the close follow-up of these patients for an extended time period to ascertain the durability of the method. Promising results were also recognized in various comorbidities of obese patients, such as hypertension, hyperlipidemia, diabetes mellitus type 2, and obstructive sleep apnea. The same positive results were not realized for
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the comorbidity of gastroesophageal reflux, for which LSG seemed to both precipitate and ameliorate symptoms. Extended follow-up time is warranted to clarify the relationship between this operation and the GERD. Disclosures Konstantinos Albanopoulos, Dimitrios Tsamis, Maria Natoudi, Leonidas Alevizos, Georgios Zografos, Emmanouil Leandros have no conflicts of interest or financial ties to disclose.
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