OBES SURG DOI 10.1007/s11695-014-1199-9

ORIGINAL CONTRIBUTIONS

Laparoscopic Sleeve Gastrectomy Using 42-French Versus 32-French Bougie: The First-Year Outcome Hadar Spivak & Moshe Rubin & Eran Sadot & Esther Pollak & Anya Feygin & David Goitein

# Springer Science+Business Media New York 2014

Abstract Background The optimal size of bougie in laparoscopic sleeve gastrectomy (LSG) remains controversial. The aim of this study was to evaluate the first-year outcome of LSG using two different sizes of bougies. Methods This study used a single institute retrospective casecontrol study of two groups of patients. Group A (N=66) underwent LSG using 42-Fr and group B (N=54) using 32Fr bougies. A medication score was applied to assess the change in comorbid conditions. Results Groups A and B's age (39.5±12 vs. 43.6±12.3 years), weight (119±17 vs. 120±20), and BMI (42.8±3.8 vs. 43.6± 6.9 kg/m2), respectively, were comparable (p=NS). Comorbid conditions were type 2 diabetes (T2DM) in 19 (29 %) vs. 23 (43 %) patients, hypertension in 22 (33 %) vs. 18 (33 %) patients, and gastroesophageal reflux (GERD) in 28 (42 %) vs. 10 (19 %) patients, respectively. At 1 year, group A vs. B BMI was (29.4±5 vs. 30±5 kg/m2) and excess weight loss was 67 vs. 65 %, respectively (p=NS). Postoperatively, T2DM (79 vs. 83 %), hypertension (82 vs. 61 %), and GERD (82 vs. 60 %) (p=NS), respectively, in groups A vs. B did not require previous medications anymore. Complications were comparable. Conclusions Our data suggest that using a 42-Fr or 32-Fr bougie does not influence LSG first-year weight loss or resolution of comorbid conditions. Long-term data is needed to conclude this issue.

H. Spivak : M. Rubin : E. Sadot : E. Pollak : A. Feygin : D. Goitein Department of Surgery C, Chaim Sheba Medical Center, 2 Sheba Rd., Tel Hashomer 56261, Israel H. Spivak (*) : M. Rubin : E. Sadot : E. Pollak : A. Feygin : D. Goitein Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel e-mail: [email protected]

Keywords Bariatric surgery . Laparoscopic surgery . Laparoscopic sleeve gastrectomy . Gastrectomy . Obesity . Hypertension . Type 2 diabetes mellitus . Gastroesophageal reflux

Introduction Laparoscopic sleeve gastrectomy (LSG) is emerging as a preferred primary weight loss procedure worldwide, and yet, its surgical technique is still controversial [1–5]. One of the most debated issues is the size of the bougie used during procedure. While larger size (50-Fr to 60-Fr) bougies initially used in LSG are generally avoidedthese days, it has been suggested that the optimal size should be well below 40-Fr [1]. Conversely, it has been shown that employing bougie ≥40-Fr is associated with the decrease in leak rates without impacting weight loss [5]. The abundant information, both professional and informal, available to the public results in online discussions regarding this issue and patients occasionally arrive in bariatric clinics asking for a particular bougie size for their surgery. We conducted this study to elucidate a potential difference in outcome between 42-Fr and 32-Fr size bougies.

Material and Methods Patients who are enrolled in the Israeli public system are referred to our center for the treatment of morbid obesity. After initial evaluation, they undergo a lengthy process that includes psychological, nutritional, and medical assessment. After a typical interval of 8 to 12 months (mostly due to operating room availability), they are randomly assigned to a surgeon, not necessarily the one who saw them initially in the clinic, for surgery.

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In the last 4 years, most of the bariatric cases performed in our hospital were LSG, and as experience was gained the surgical technique was stabilized. Each of the four bariatric surgeons in our hospital performs hundreds of weight loss procedures in the private and public system each year, and the combined experience is more than 4,000 bariatric cases (excluding gastric banding). The prominent difference between of the surgeons’ technique, however, is that two surgeons use a 42-Fr bougie for calibration and the other two use 32-Fr. Highlights of Surgical Technique LSG has been performed in our center since 2006. After an initial learning curve (all surgeons were well-experienced bariatric surgeons before introduction of LSG), the technique was stabilized: The line of transaction starts 1–2 cm from the pylorus to the angle of Hiss, leaving a uniform and long tubelike sleeve. Full mobilization of the stomach is completed, including all posterior attachments and exposure of the left crus of the diaphragm, prior to placing the bougie. However, two surgeons (HS and MR) use a 42-Fr bougie while the other two (AF and DG) use a 32-Fr bougie. Five to six staple cartridges are typically used in each case, and intraoperative staple line homeostasis is achieved by clips or suturing. The fundus is always entirely removed. No buttressing material is used. Low-molecular weight heparin was given in the next day of surgery based on the surgeons’ preference. The patients were discharged home after 2–3 nights at the hospital and were followed mostly in their community by dietitians and other professionals. In 2013, after approval by the hospital IRB, we randomly selected 122 patients who were operated upon in 2011 and completed 1 year of follow-up. Based on the operating surgeons and their bougie preference, we assigned the groups to A (42-Fr bougies, N=66) and B (32-Fr bougies, N=54). A missing follow-up information was obtained using telephone questionnaire and by repeated clinic appointments. To assess the change in three major comorbid conditions before and after surgery, we use a medication score and assigned a number for each level as follows: For type 2 diabetes mellitus (T2DM): 0 = no disease, 1 = borderline or controlled by diet, 2 = oral type of medications only, and 3 = subcutaneous injection of insulin. For hypertension: 0 = no disease, 1 = borderline or treated by diet alone, 2 = only one type of medication, and 3 = more than one type of medications. For gastroesophageal reflux (GERD): 0 = no disease, 1 = borderline or controlled by diet and/or oral antacids, and 3 = proton pump inhibitors. Data Analysis Descriptive and comparative statistics were performed using SPSS v21 (SPSS, Inc., Chicago, IL, USA). Continuous

variables are reported as mean and standard deviation unless otherwise specified and were compared using the Student’s t test. Categorical variables were compared using χ2 or the Fisher’s exact test depending on the number of observations. A p value ≤0.05 was considered significant in all cases.

Results Table 1 depicts demographic data of the two groups. The groups were comparable for preoperative weight, excess weight, BMI, and gender ratio (p=NS). Group A showed a trend to be 4 years younger (p=0.07). Preoperative comorbid conditions (Table 2) were similar in both groups except for GERD that turned out to be statistically stronger for group A. Figure 1 presents the change in BMI at baseline and at 1 year post surgery. Both groups experienced similar (p=NS) reduction in BMI of about 13 kg/m2 and two thirds of excess weight loss (%EWL). Table 2 depicts the change in the three comorbid conditions prior and at 1 year post surgery as calculated by the medication score. In both groups, T2DM, hypertension, and GERD improved or were cured in the vast majority of patients. Adverse Outcomes One group B patient had to be converted during surgery to open laparotomy due to uncontrolled bleeding from the splenic hilum. Postoperative recovery was unremarkable. In group A, one patient was readmitted to the hospital a week after discharge with acute abdomen due to portal vein thrombosis. He underwent percutaneous transhepatic thrombolysis followed by abdominal exploration. He subsequently fully recovered following 18 days in the hospital. There were three patients in group A and two in group B who required blood and/or fresh frozen plasma transfusion for postoperative bleeding. Of these, two in group A and one in group B went through exploratory laparoscopy to control bleeding from the staple line. There were no leaks or deaths in these series, and hospital stay was 2.5±1.4 days and 2.2±0.7 days for groups A and B, Table 1 Baseline characteristic of patients prior to surgery Variable

Group A (N=66)

Group B (N=54)

p value

Age (years) Weight (kg) Height (cm) BMI (kg/m2)

39.5±12 119±17 167±9.9 42.8±3.8

43.6±12.3 120±20 166±9.3 43.6±6.9

0.07 0.7 0.6 0.3

Gender (%) Female Male

65.2 34.8

66.7 33.3

0.9

OBES SURG Table 2 Associated comorbidities before and after surgery Variable

T2DM Preoperative (N) Postoperatively cured (N) Postoperatively improved (N) Postoperatively deteriorated (N) HTN Preoperative (N) Postoperatively cured (N) Postoperatively improved (N) Postoperatively deteriorated (N) GERD Preoperative (N) Postoperatively cured (N) Postoperatively improved (N) Postoperatively deteriorated (N)

Group A (N=66)

Group B (N=54)

28.8 % (19) 42.6 % (23) 78.9 % (15) 82.6 % (19) 78.9 % (15) 91.3 % (21) 5.3 % (1)

None (23)

p value

0.11 1 0.4 0.5

33.3 % (22) 33.3 % (18) 1 81.8 % (18) 61.1 % (11) 0.2 91.0 % (20) 72.2 % (13) 0.2 None (22) None (18) NA 42.4 82.1 85.7 3.6

% (28) 18.9 % (10) % (23) 60 % (6) % (24) 60 % (6) % (1) 10 % (1)

0.006 0.2 0.2 0.5

Resolution of comorbidities T2DM type 2 diabetes mellitus, HTN hypertension, GERD gastroesophageal reflux disease

respectively (p=NS). Readmission due to dehydration, nausea, or abdominal pain occurred in five patients in group A and two in group B (p=NS).

Discussion We compared the preliminary outcome of the two ways of performing LSG using an identical surgical and perioperative technique differing solely in the bougie size utilized. The primary message of this study is that the size of the calibration bougie (42-Fr vs. 32-Fr) has no predictive valueat least in the first year, in regard to weight reduction and resolution of comorbidities, as these were identical for the two groups and

comparable to other reported data [5-8]. To the best of our knowledge, this is the first “head-on” comparison between two bougie sizes from a single institution with identical settings. Recently, the International Sleeve Gastrectomy Expert Panel Consensus Statement for best practice guidelines (1) concluded in an overwhelming majority that a bougie not wider than 32–36-Fr should be used in LSG procedures. However, about half of the panel participants stated that one should not place the staple line tight along the bougie, casting doubt as to the actual diameter of the sleeve constructed. In addition, the panel opinion was that one should stay away from the pylorus and the transection should start at 2–4 cm proximal to it. On the other hand, Parikh et al. (5) following a meta-analysis on 9,991 LSG patients recommended the use of ≥40-Fr size since they found out that it may decrease the leak rate without impacting %EWL up to 3 years. Argument for and against the small-sized bougie can go either way. On one hand, there is a concern that the more stomach tissue is preserved, the more amenable to stretch it will be, and longterm sleeve dilation will ultimately cause failure. On the other hand, smaller-sized bougie may “push” towards secondary patient behavior changes (postoperatively): owing to food restriction, some patients turn themselves to sweets, in the liquid form (sodas) or the semi-liquid form (ice-creams, chocolates, etc.), and they are then likely to regain weight. In the practical aspect, the actual sleeve size is influenced by variations of surgeons’ technique, e.g., the way one places the stapler alongside the bougie, distance from the pylorus, etc. Therefore, leaving behind a uniform tube-like sleeve from the gastroesophageal junction to the pylorus affects the sleeve's size and function. Our series echoes the previous data that LSG improves or cures obesity-related comorbid conditions at 1 year follow-up [6, 7]. However, one of the drawbacks of our study is that we used only a medication score to judge the change in illnesses. Nevertheless, following surgery, management of the patients and reduction of their medications were done by community physicians based on clinical criteria and independent of the surgeons. As a result, the score carries valuable information and an indication for the change in the studied comorbidities. Other limitations of this study are its retrospective, non-randomized nature, and the relatively short duration of follow-up.

Conclusion

Fig. 1 Change in body mass index in 1 year

In the first year, there is no difference in outcome between thestudied bougiesizes. Long-term data is

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needed to conclude if below certain size there is a preferable bougie at all.

Conflict of Interest Hadar Spivak, Mosh Rubin, Eran Sadot, Esther Pollack, Anya Feigin, and David Goitein have no conflicts of interest to declare.

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References 1. Rosenthal RJ et al. International Sleeve Gastrectomy. Expert Panel Consensus Statement: best practice guidelines based on experience of >12,000 cases. Surg Obes Relat Dis. 2012;8(1):8–19. 2. Atkins ER, Preen DB, Jarman C, et al. Improved obesity reduction and co-morbidity resolution in patients treated with 40-French bougie

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versus 50-French bougie four years after laparoscopic sleeve gastrectomy. Analysis of 294 patients. Obes Surg. 2012;22(1):97–104. Yuval JB, Mintz Y, Cohen MJ, et al. The effects of bougie caliber on leaks and excess weight loss following laparoscopic sleeve gastrectomy. Is there an ideal bougie size? Obes Surg. 2013;23(10):1685–91. Lazzati A, Guy-Lachuer R, Delaunay V et al. Bariatric surgery trends in France: 2005-2011. Surg Obes Relat Dis. 2013;S1550–7289(13): 00253–0. doi:10.1016/j.soard.2013.07.015. Parikh M, Issa R, McCrillis A, et al. Surgical strategies that may decrease leak after laparoscopic sleeve gastrectomy: a systematic review and meta-analysis of 9991 cases. Ann Surg. 2013;257(2): 231–7. Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012;366(17):1567–76. Peterli R, Borbély Y, Kern B, et al. Early results of the Swiss Multicentre Bypass or Sleeve Study (SM-BOSS): a prospective randomized trial comparing laparoscopic sleeve gastrectomy and Rouxen-Y gastric bypass. Ann Surg. 2013;258(5):690–5.

Laparoscopic sleeve gastrectomy using 42-French versus 32-French bougie: the first-year outcome.

The optimal size of bougie in laparoscopic sleeve gastrectomy (LSG) remains controversial. The aim of this study was to evaluate the first-year outcom...
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