OBES SURG DOI 10.1007/s11695-014-1432-6

ORIGINAL CONTRIBUTIONS

A Comparison of a Single Center’s Experience with Three Staple Line Reinforcement Techniques in 1,502 Laparoscopic Sleeve Gastrectomy Patients Tyler W. Barreto & Paul R. Kemmeter & Matthew P. Paletta & Alan T. Davis

# Springer Science+Business Media New York 2014

Abstract Objective This study aimed to compare outcomes of laparoscopic sleeve gastrectomy (LSG) patients based on three types of staple line reinforcement (SLR): seromuscular suturing (imbrication), absorbable polymer membrane (APM), and bovine pericardial strips (BPS). Background LSG represented 67.3 % of bariatric procedures performed in Michigan in 2013, and its prevalence continues to rise. Multiple studies suggest that SLR can potentially reduce the incidence of complications. However, the current literature is limited secondary to a small sample size and is not conclusive on which type of reinforcement technique is best in reducing the risk of complications. Methods The charts of 1,526 consecutive patients who underwent an LSG from January 2005 to January 2013, by four experienced surgeons, were reviewed. Data include patient demographics, reinforcement technique utilized, length

T. W. Barreto (*) Grand Rapids Medical Education Partners Family Medicine Residency, 300 Lafayette SE, Suite 4000, Grand Rapids, MI 49503, USA e-mail: [email protected]

of hospitalization, complications, hospital readmission rates, and mortality. Results Of 1,502 patients who underwent an LSG and met inclusion/exclusion criteria, 373 (24.8 %) were reinforced using imbrication, 269 (17.9 %) with BPS, and 860 (57.3 %) with APM. Patient demographics and complication rates were similar between groups. A statistically significant difference occurred in length of stay, readmission, and reoperation rates (p30 % hematocrit change with no alternative identifiable source. Surgical Technique All surgeries were performed by four experienced bariatric surgeons. All patients received enoxaparin 40 mg subcutaneously 2 h preoperatively. One surgeon always used BPS (surgeon BPS), two surgeons always used APM (surgeons APM 1 and APM 2), and one surgeon utilized either APM, staple line imbrication, or both (surgeon Imbrication). Other than the type of SLR, all surgeons utilized a similar technique in performing the LSG. Briefly, the greater curvature of the stomach was fully mobilized from approximately 3 cm proximal to the pylorus and proceeded to the left crus with dissection of the gastrohepatic fat pad utilizing either the HARMONIC scalpel (Ethicon Endo-Surgery, Cincinnati, OH) (surgeons BPS and APM 1) or the ENSEAL device (Ethicon Endo-Surgery, Cincinnati, OH) (surgeons APM 2 and Imbrication). Resection of the stomach was initiated between 3 and 5 cm proximal to the pylorus depending on the thickness of the antrum utilizing an ECHELON FLEX ENDOPATH 60-mm linear stapler (Ethicon Endo-Surgery, Cincinnati, OH). Staple height was dependent on the thickness of the tissue being resected, with a closed height of 2.0–2.3 mm (green or black loads) for the antrum and body, and 1.8 mm (gold load) for the fundus when tissue thickness was decreased. A 34-Fr bougie was utilized to size the sleeve for all four surgeons, and attempts were made to avoid narrowing of the incisura angularis or stapling the esophagus. Intraoperative endoscopies were performed based on the surgeon’s preference but utilized mostly by surgeons BPS and APM 1. All identified hiatal hernias were repaired. Staple lines of patients in the imbrication group were imbricated utilizing a running seromuscular stitch of absorbable suture. In all groups, the greater omentum was secured to the region of the staple line utilizing absorbable suture. For patients in the BPS and APM groups, surgical clips were utilized when necessary to help with hemostasis (primarily surgeons BPS and APM 2), but were not used in the imbrication group. Postoperatively, patients received care by experienced bariatric nurses following established protocols, including receiving enoxaparin 30 mg subcutaneously bid. Contrast studies were obtained selectively on patients with clinical signs of a possible leak. Patients were discharged when able to meet oral intake goals, pain was adequately controlled, and able to ambulate independently. Statistical Analysis Quantitative data are expressed as the mean and standard deviation, while nominal data are expressed as a percentage. Comparisons for APM versus BPS and imbrication for quantitative variables were performed using the t test. Comparisons for all three groups for

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quantitative data were made using the ANOVA test. Nominal variables were evaluated using the χ 2 test. Data were analyzed using IBM SPSS Statistics v. 21 (Armonk, NY).

Results A total of 1,526 charts were reviewed. Twenty-four patients were excluded secondary to an unknown type of reinforcement or use of two types simultaneously, leaving 1,502 patients. Of the LSG performed, 373 (24.8 %) were reinforced by imbrication, 269 (17.9 %) by BPS, and 860 (57.3 %) by APM. Patient demographics are described in Table 1. Patient age ranged from 18 to 75 years (mean 46.1 years), and body mass index (BMI) ranged from 35 to 100 kg/m2 (mean 49.7 kg/m2). None of the study demographics were statistically different between groups. Bleeding occurred in 14 (3.8 %) of imbrication, 16 (5.9 %) of BPS, and 47 (5.5 %) of APM cases (p=0.36). The vast majority of bleeds were diagnosed related to a drop in hemoglobin 25 % of readmissions being related to a leak. Finally, when comparing our LSG leak rates to those of other experienced surgeons, 0.3 % in the imbrication and APM groups is on par with rates reported from the MBSC on >11,000 patients of 0.53 % and by Rosenthal on >12,000 patients of 1.06 %, which makes the BPS group rate of 1.5 % higher among experienced surgeons [25]. Despite a liberal definition of bleeding, postoperative bleed rates were not statistically different between groups, but did make our rates appear high at 3.8–5.9 %. However, a clinically significant bleed occurred in only one patient (0.07 %) from the BPS group. This rate compares favorably with the MBSC data which show transfusion requirements on 1.45 % of patients (personal communication, January 27, 2014).

Our study also demonstrated a difference in length of hospital stay (LOS), with BPS having the shortest stay of 1.9 days compared to that of APM and imbrication of 2.1 days. Although this difference is statistically significant, the clinical significance of five additional hours within the hospital is uncertain. These hours could represent financial savings to the hospital; however, the higher readmission rate in the BPS group would eliminate any potential savings. Unfortunately, our study was not designed to evaluate hospital costs, and this will be the subject of a future investigation. There are some weaknesses of our study. First, each surgeon has extensive laparoscopic bariatric surgical experience, including intracorporeal suturing, and therefore, the results may not be applicable across less experienced surgeons. For example, imbricating the staple line is technically more demanding than utilizing buttressing material, and therefore, the learning curve associated with this would presumably be steeper. Second, since the reinforcement technique was tied to specific surgeons, variation in surgical skill and patient management could account for any differences between groups. Third, each surgeon has a consulting agreement with either Baxter Healthcare (surgeon BPS) or W.L. Gore & Associates (surgeons APM 1, APM 2, and Imbrication) which could bias the decision for type of buttressing technique utilized. Fourth, although all surgeons were experienced bariatric surgeons, incorporation of the LSG introduced a new learning curve, and over the course of this study, there were subtle variations in technique within each SLR group which are impossible to track but would impact outcomes. Finally, neither the financial impact of eliminating implant costs compared to increased operative time with imbrication nor the cost associated with readmission and reoperation were examined, but will be a focus of a future investigation. Until further data are available, each surgeon has opted to stick with his or her SLR technique of choice.

Conclusion LSG is becoming the procedure of choice in metabolic surgery, and surgeons must use evidenced-based medicine in an attempt to reduce the risk of serious complications related to this procedure. Comparison of BPS, APM, and imbrication of the staple line in 1,502 LSG patients through a single center by four experienced surgeons demonstrated that BPS is associated with significantly higher readmission and reoperation rates with a trend towards a higher leak rate. There is no significant difference in bleed rates between the three reinforcement techniques. Although length of stay was shortest in the BPS group, this was offset by higher readmission rates.

OBES SURG Conflict of Interest Dr. Kemmeter reports consulting fees from Ethicon Endo-Surgery and W. L. Gore & Associates outside the submitted work. Drs. Barreto, Paletta, and Davis have nothing to disclose. Statement of Informed Consent For this type of study, formal consent is not required. Statement of Human and Animal Rights All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Source of Funding There was no funding for this project.

References 1. Zhao Yand Encinosa W. Bariatric surgery utilization and outcomes in 1998 and 2004. Healthcare cost and utilization project: Statistical Brief #23. 2007;1-7. 2. Campanile FC, Boru CE, Rizzello M, et al. Acute complications after laparoscopic bariatric procedures: update for the general surgeon. Langenbeck Arch Surg. 2013;398(5):669–86. 3. Gentileschi P, Camperchioli I, D’Ugo S, et al. Staple-line reinforcement during laparoscopic sleeve gastrectomy using three different techniques: a randomized trial. Surg Endosc. 2012;26(9):2623–9. 4. Choi YY, Bae J, Hur KY, et al. Reinforcing the staple line during laparoscopic sleeve gastrectomy: does it have advantages? A metaanalysis. Obes Surg. 2012;22(8):1206–13. 5. Daskalakis M, Berdan Y, Theodoridou S, et al. Impact of surgeon experience and buttress material on postoperative complications after laparoscopic sleeve gastrectomy. Surg Endosc. 2011;25(1):88–97. 6. Glaysher M, Khan OA, Mabvuure N, et al. Staple line reinforcement during laparoscopic sleeve gastrectomy: does it affect clinical outcomes? Int J Surg. 2013;11(4):286–9. 7. Gagner M and Buchwald J. Comparison of laparoscopic sleeve gastrectomy leak rates in four staple-line reinforcement options: a systematic review. Surg Obes Relat Diseas. 2014 Jan 28. 8. Gagner M. Meta-analysis of leaks following laparoscopic vertical sleeve gastrectomy. Obes Surg. 2011;21(8):958. abstract PL02-05; presented at the XVI World Congress of International Federation of the Surgery of Obesity (IFSO), Aug 31-Sept 3, 2011, Hamburg, Germany. 9. Consten, Dakin GF, Robertus JL, et al. Perioperative outcome of laparoscopic left lateral liver resection is improved by using a bioabsorbable staple line reinforcement material in a porcine model. Surg Endosc. 2008;22:1188–93.

10. Thaker, Matthews BD, Linehan DC, et al. Absorbable mesh reinforcement of a stapled pancreatic transection line reduced the leak rate with distal pancreatectomy. J Gastrointest Surg. 2007;11:59–65. 11. Yamamoto M, Hayashi MS, Nguyen NT, et al. Use of Seamguard to prevent pancreatic leak following distal pancreatectomy. Arch Surg. 2009;144:894–9. 12. Consten EC, Gagner M, Pomp A, et al. Decreased bleeding after laparoscopic sleeve gastrectomy with or without duodenal switch for morbid obesity using a stapled buttressed absorbable polymer membrane. Obes Surg. 2004;14:1360–6. 13. Franklin Jr ME, Ramila GP, Treviño JM, et al. The use of bioabsorbable staple line reinforcement for circular stapler (BSG “Seamguard”) in colorectal surgery. Surg Laparosc Endosc Percutan Tech. 2006;16(6):411–5. 14. Nguyen NT, Longoria M, Chalifoux S, et al. Bioabsorbable staple line reinforcement for laparoscopic gastrointestinal surgery. Surg Technol Int. 2005;14:107–11. 15. de la Portilla F, Zbar AP, Rada R, et al. Bioabsorbable staple-line reinforcement to reduce staple-line bleeding in the transection of mesenteric vessels during laparoscopic colorectal resection: a pilot study. Tech Coloproctol. 2006;10:335–8. 16. Angrisani L, Lorenzo M, Borrelli V, et al. The use of bovine pericardial strips on linear stapler to reduce extraluminal bleeding during laparoscopic gastric bypass: prospective randomized clinical trial. Obes Surg. 2004;14:1198–202. 17. Stammberger U, Klepetko W, Stamatis G, et al. Buttressing the staple line in lung volume reduction surgery: a randomized three-center study. Ann Thorac Surg. 2000;70:1820–5. 18. Murray KD, Ho CH, Hsia JYJ, et al. The influence of pulmonary staple line reinforcement of air leaks. Chest. 2002;122:2146–9. 19. Al Hajj GN, Haddad J. Preventing staple-line leak in sleeve gastrectomy: reinforcement with bovine pericardium vs. oversewing. Obes Surg. 2013;23(11):1915–21. 20. Bulbuller N, Aslaner A, Oner OZ, et al. Comparison of four different methods in staple line reinforcement during laparoscopic sleeve gastrectomy. Int J Clin Exp Med. 2013;6(10):985–90. 21. D’ugo S, Gentileschi P, Benavoli D, et al. Comparative use of different techniques for leak and bleeding prevention during laparoscopic sleeve gastrectomy: a multicenter study. Surg Obes Relat Diseas. 2013 Nov 12. 22. Baker RS, Foote J, Kemmeter P, et al. The science of stapling and leaks. Obes Surg. 2004;14(10):1290–8. 23. Simon TE, Scott JA, Brockmeyer JR, et al. Comparison of staple-line leakage and hemorrhage in patients undergoing laparoscopic sleeve gastrectomy with or without Seamguard. Am Surg. 2011;77:1665–8. 24. Gagner M, Deitel M, Erickson AL, et al. Survey on laparoscopic sleeve gastrectomy (LSG) at the Fourth International Consensus Summit on Sleeve Gastrectomy. Obes Surg. 2013;23:2013–7. 25. Rosenthal R. International Sleeve Gastrectomy Expert Panel Consensus Statement: best practice guidelines based on experience of 12,000 cases. Surg Obes Relat Dis. 2012;8:8–19.

A comparison of a single center's experience with three staple line reinforcement techniques in 1,502 laparoscopic sleeve gastrectomy patients.

This study aimed to compare outcomes of laparoscopic sleeve gastrectomy (LSG) patients based on three types of staple line reinforcement (SLR): seromu...
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