Laparoscopic Sleeve Gastrectomy

| June 18, 2009

By Ismael Court, MD; Omar Bellorin, MD; Fernando Dip, MD; Christopher DuCoin, MD; Samuel Szomstein, MD, FACS; and Raul J. Rosenthal, MD, FACS

All from the Bariatric & Metabolic Institute, Section of Minimally Invasive Surgery, Cleveland Clinic Florida, Weston, Florida

Key words: Bariatric surgery, laparoscopy, morbid obesity, Roux-en-Y gastric bypass, sleeve gastrectomy

Introduction
Surgery has become the most effective option in the management of morbid obesity and comorbid conditions.[1–3] Surgery for morbid obesity provides excellent short-term and long-term outcomes, decreasing overall mortality and providing a marked survival advantage.[5] Sleeve gastrectomy (SG) appears as a novel surgical treatment option to manage morbid obesity.[3–10]

EVOLUTION OF SLEEVE GASTRECTOMY AS A PRIMARY PROCEDURE FOR WEIGHT LOSS IN MORBID OBESITY
Biliopancreatic diversion (BPD) was described by Scopinaro in 1976.[12] In 1998, Hess and Marceau, published a modification of this procedure called BPD with duodenal switch (BPD-DS).[13,14] The BPD-DS procedure described a vertical gastrectomy, called sleeve gastrectomy. BPD-DS combines a vertical SG with a final gastric volume of approximately 100 to 150mL, and a duodenal switch with a common channel of 100cm and an alimentary limb of 150cm. The SG functioned as the restrictive component of the procedure replacing the need for a distal gastrectomy.

The SG functioned as the restrictive component of the procedure, replacing the need for a distal gastrectomy. This technique resulted in greater weight loss with reduced morbidity when compared to the original Scopinaro procedure, including reduction in ulcerogenicity and malabsorption with hypoproteinemia, hypocalcaemia, and dumping syndrome.[6,16] BPD-DS creates moderate restriction while preserving the vagal integrity, lesser curvature, antrum, pylorus, and the first part of the duodenum. Gagner and colleagues published the first results on BPD-DS done by laparoscopy in 2000.[18] The BPD-DS resulted in effective weight loss with an acceptable morbidity.[18] It was also effective in providing and maintaining excess weight loss (EWL).[17–20] Laparoscopic sleeve gastrectomy (LSG) was subsequently recommended as an initial step of a two-step procedure in the management of superobese patients or those with a high operative risk due to extensive comorbid conditions to minimize the associated morbidity and mortality. Regan et al in 2003 described a two-stage procedure in seven super-superobese patients who underwent LSG as a first-stage procedure followed by laparoscopic Roux-en-Y gastric bypass (LRYGB) as a second-stage for more definitive treatment of obesity.[21] Eleven months after the LSG, and prior to the second-stage procedure, average EWL was 33 percent (37kg).[21] Their initial experience suggested that the two-stage approach was feasible, and that the LSG was effective in the short term at achieving significant EWL. A similar result was published by Milone et al in 2005 that showed the mean EWL after LSG at six months was 45.5 percent in a study about the efficacy of LSG compared with the intragastric balloon.[22] As surgical experience increased with LSG, the role of this procedure began to change to that of a primary, restrictive bariatric procedure. In 2005, Mognol et al and Moon Han et al published their early results with LSG as a primary procedure for weight loss, showing an average EWL after a year of 51 percent (10 patients) and 83.3 percent (60 patients), respectively.[23, 24] Besides the significant weight loss, it was evident an important reduction in comorbid conditions, including diabetes, hypertension, and dyslipidemia, occurred.[22–24] In 2005, Baltazar et al also presented the experience with the LSG in patients with BMI>55 with severe medical conditions as an alternative to adjustable bands and for conversion of gastric banding patients, with good results in BMI reduction in each case.[25] In 2006, Cottam et al published their initial experience performing LSG on 126 patients with a mean BMI of 65, showing significant EWL and reduction in comorbidities.[26] In 2006, we published our initial experience that showed the early results in 30 patients who underwent LSG as a primary procedure to weight loss. It showed that the mean EWL was 52.8 percent at six months after the surgery, with one major complication and no mortality.[9] In late 2006, Himpens et al published the first randomized study that compared gastric banding and LSG. They concluded that weight loss and satiety after one year and three years are better after LSG than gastric banding.[27] In 2007, Gagner highlighted the benefits of SG, including the low rate of complications, avoidance of foreign material, maintenance of normal gastrointestinal continuity, absence of malabsorption, ability to convert to multiple other operations, and reduction of the ghrelin-producing stomach mass.[28] In the same year, Vidal et al from Spain published a prospective study that suggested that LSG and LRYGB result in a similar rate of type 2 diabetes mellitus (T2DM) resolution at four months after surgery.[29] This concept brought attention to the effects of SG for T2DM patients. In October 2007, at the First International Consensus Summit for Sleeve Gastrectomy, it was established that “LSG is being performed for super-obese and high-risk patients, but its indications have been increasing. A second-stage bariatric operation may be performed if necessary. Long-term results of LSG and further networking are anxiously awaited.”[32] In early 2008, Karamanakos et al published a double-blind study that showed markedly reduced ghrelin levels in addition to increased peptide YY (PYY) (anorexigen) levels after LSG, are associated with greater appetite suppression and excess weight loss compared with LRYGB.[31] In the same year, we published our experience with 147 patients who underwent LSG. Our results suggested that LSG is a safe one-stage restrictive technique as a primary procedure for weight loss in the morbidly obese with an acceptable perioperative complication rate.[30] Another important finding was shared in September 2008. Yehoshua et al published their study showing a notably higher mean pressure in the sleeved stomachs (43mmHg) versus complete stomachs (34mmHg), stressing that it might be an important element in the mechanism of weight loss.[33] Also in September 2008, Vidal et al published their second report in 91 T2DM patients who underwent LSG or RYGB. At twelve months postoperative, SG was as effective as RYGB in inducing remission of T2DM.[35] In December 2008, Rubin et al published their result in 120 consecutive patients undergoing LSG. They showed 53 percent excess BMI lost during a median follow-up of 11.7 months and concluded that LSG is a safe and effective procedure for morbid obesity.[34] In March 2009, we published our midterm follow-up after LSG as a final approach for morbid obesity. The percent of EWL was 67.9 percent at 24 months. We concluded that LSG is a safe and effective surgical procedure for the morbidly obese, and EWL is acceptable after two years.[36]

SURGICAL TECHNIQUE
We use a seven-trocar technique for LSG with identical port placement to our LRYGB procedure (Figure 1). After induction of anesthesia and endotracheal intubation, the abdominal cavity is accessed through a 1cm supraumbilical incision using an Optiview trocar™ (Ethicon EndoSurgery, Cincinnati, OH). The abdominal cavity is insufflated with carbon dioxide to a pressure of 15mmHg. The operating ports are inserted under direct vision. The liver is retracted cranially, and the gastroesophageal (GE) junction is exposed. A point on the greater curvature approximately 6cm proximal to the pylorus is identified as the distal extent of the resection. The Harmonic scalpel™ (Ethicon EndoSurgery, Cincinnati, OH) is used to divide the vessels along the greater curve up to the angle of His. A 38 Fr bougie is inserted transorally to the level of the distal stomach. Linear cutting staplers (Endopath®, Ethicon EndoSurgery, Cincinnati, Ohio) are used to vertically transect the stomach, creating a narrow gastric tube with an estimated capacity of 150mL (Figure 2). The staple line is then oversewn with a running 2-0 Vicryl® suture. The resected stomach is placed in a specimen bag and extracted. All patients have a routine gastrograffin swallow study on postoperative Day 1 and are commenced on oral fluids if normal.

AUTHORS’ EXPERIENCE OF LAPAROSCOPIC SLEEVE GASTRECTOMY AS A PRIMARY BARIATRIC PROCEDURE
At the Bariatric Institute at Cleveland Clinic Florida, 357 LSGs, as a one-stage restrictive procedure for weight loss, have been performed between November 2004 and March 2009. The majority (n=339) were performed as primary procedures. Fourteen patients underwent LSG as a secondary procedure after failed LAGB, previous jejunoileal bypass (n=2), biliopancreatic divertion with weight regain (n=1), or failed RYGB (n=1). We recently published our mid-term follow-up after LSG as a final approach for morbid obesity.[36] Our retrospective analysis included 130 consecutive patients who underwent LSG as a final procedure for morbid obesity between November 2004 and January 2007, and who had complete 3 to 24 months of follow-up. The mean weight loss was 21, 31.2, 37.4, 39.5, and 41.7kg at 3, 6, 12, 18, and 24 months, respectively. The mean EWL was 33.1, 50.8, 62.2, 64.4, and 67.9 percent at 3, 6, 12, 18, and 24 months, respectively. The mean operative time was 97 minutes (range 58–180) and all procedures were completed laparoscopically. The mean hospital stay was 3.2 days (range 1–19). One patient (0.7%) had leakage at the staple line, while four patients (2.8%) developed trocar site infection. Three patients (2.1%) complained of symptoms of gastroesophageal reflux disease (GERD), three patients (2.1%) developed symptomatic gallstones, and trocar site hernia was present in one (0.7%) patient, with zero mortality in this series.[36]

METABOLIC SYNDROME AND LAPAROSCOPIC SLEEVE GASTRECTOMY

Bariatric surgery is highly effective in improvement of obesity-related conditions, including T2DM and metabolic syndrome (MS).[38] The mechanisms of action have not been completely elucidated yet. Data suggest a shared role between malabsorptive and restrictive procedures.[39] It would be determinant in the T2DM resolution, the remaining pancreatic b-cell function after the surgery.[41] The high level of GLP-1 after meals seen when ingested glucose reaches the ileum rapidly in the LRYGB, would be responsible to induce improvements in glucose and insulin metabolism,[44] but GLP-1 would not be the only critical factor for the early changes in glucose tolerance.[45] Although LSG has provided excellent outcomes regarding resolution of MS and T2DM in several series,[26,29,35,40] the GLP-1 theory cannot explain it completely. Bernstine et al published that LSG has no effect on gastric emptying,[43] and Yehoshua et al showed a notably higher mean pressure in the sleeved stomachs (43mmHg) versus complete stomachs (34mmHg).[33] LSG is a restrictive procedure and also induces important reduction in the plasma levels of ghrelin.[31,42,43] The secondary low intake could be the most important factor in gaining the glucose-insulin homeostasis.

LAPAROSCOPIC SLEEVE GASTRECTOMY AND COMPLICATIONS
The complication rates of LSG range from 2.9 to 15.3 percent, with an overall reported mortality rate of 0.39 percent.[24,26,27,40,47–49] Complications can be classified as acute or chronic, major or minor. Bleeding, leaks, and stenosis are always presented as acute complications that are mostly major and sometimes life-threatening conditions. Strictures and GERD are considered chronic complications and are mostly minor. Some authors claim that oversewing the staple line47 or using reinforcement material50 can prevent bleeding, which occurs in 0.7 to 1.8 percent of patients.[47,50] Leakage, which remains the most serious complication, is found in 0.7  to 0.8 percent of patients.[36,50] Symptoms of GERD are being reported in 2.8 percent of patients after LSG.[36] A possible explanation for this side effect is the decrease in gastric volume and the presence of an intact pylorus, resulting in increased intragastric pressure and reflux. LSG appears to be safe overall when compared to other well-established bariatric procedures.

SLEEVE AND THE INSURANCE INDUSTRY

The American Medical Association (AMA) has not yet authorized the codes for sleeve gastrectomy. Most insurance companies deem the gastric sleeve to be experimental, and so this specific procedure is usually not a covered benefit. There are only two insurance companies that cover the procedure—Blue Cross® and Blue Shield® Federal Employee Plan (FEP) and Oxford Health Insurance® from United Healthcare Network®. Medicaid officially states that sleeve gastrectomy is investigational. There are exceptional cases that can be covered by Medicaid.

There are signs of progress with multiple insurance companies. It should be expected that in 2010 sleeve gastrectomy have its own code and a formal acceptance.

CONCLUSION
Laparoscopic sleeve gastrectomy is an effective primary restrictive procedure to achieve weight loss. It is a relatively straightforward procedure that can be performed laparoscopically with an extremely low conversion rate. LSG is technically feasible in high-risk patients, and also in super-obese patients with BMI>70kg/m2. As our experience with LSG is expanding, we are attempting to identify definitive indications for LSG in our patient population. There are no guidelines regarding age limit in LSG. In our experience, the age range was 12 to 79 years of age. LSG was also an option for 14 patients with failed laparoscopic adjustable gastric banding (LAGB), as other groups have also published.[37,11] We also perform LSG for morbidly obese adolescents and patients on lifelong anticoagulation to avoid marginal ulcer relation problems more commonly associated with RYGB. LSG could be appropriate for very high-risk patients with significant comorbidity, low BMI[35–40] with comorbidity, and low BMI requiring a second surgical procedure (such as kidney or liver transplantation, joint replacement, or recurrent incisional hernia repair). We do not perform LSG as a staged procedure. We recommend LRYGB as the procedure of choice in patients with a BMI>50kg/m2 with comorbidity.
The relationship between laparoscopic sleeve gastrectomy and T2DM is a topic that requires further research, as early results have shown an improvement in the control of T2DM after LSG and even the resolution in many patients.[29,31,35] Important additional research should also include long-term outcome studies about the ghrelin levels after LSG and appetite suppression.[31] It has been hypothesized that this lower ghrelin level could be one of the explanations why patients who have failed LAGB can improve with LSG. With so many promising topics surrounding the LSG procedure, it is easy to see why it has become the topic of discussion in the bariatric surgery community. It is evident that a growing number of surgeons think that LSG is an excellent option for morbid obesity, as was discussed at the last International Consensus Summit for Sleeve Gastrectomy in March 2009. It will be interesting to see the evolution of LSG as an option in terms of codification and coverage by insurance carriers.

In conclusion, LSG can be performed with minor complications and low mortality. It has been demonstrated to be a safe and effective procedure in the short and midterm and an adequate alternative for failed LAGB. Prospective studies are required to determine the long-term outcome, the efficacy of maintenance of weight loss, and resolution of comorbid conditions.

References
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21.    Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg. 2003;13(6):861–864.
22.    Milone L, Strong V, Gagner M, Laparoscopic sleeve gastrectomy is superior to endoscopic intragastric balloon as a first stage procedure for super-obese patients (BMI > or =50) Obes Surg. 2005;15(5):612–617.
23.    Mognol P, Chosidow D, Marmuse JP. Laparoscopic sleeve gastrectomy as an initial bariatric operation for high-risk patients: initial results in 10 patients. Obes Surg. 2005;15(7):1030–1033.
24.    Moon Han S, Kim WW, Oh JH. Results of laparoscopic sleeve gastrectomy (LSG) at 1 year in morbidly obese Korean patients. Obes Surg. 2005;15(10):1469–1475.
25.    Baltasar A, Serra C, Perez N, et al. Laparoscopic sleeve gastrectomy: a multi-purpose bariatric operation. Obes Surg. 2005;15(8):1124–1128.
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30.    Tucker ON, Szomstein S, Rosenthal RJ. Indications for sleeve gastrectomy as a primary procedure for weight loss in the morbidly obese. J Gastrointest Surg. 2008;12(4):662–667.
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46.    Bernstine H, Tzioni-Yehoshua R, Groshar D, et al. Gastric emptying is not affected by sleeve gastrectomy—scintigraphic evaluation of gastric emptying after sleeve gastrectomy without removal of the gastric antrum. Obes Surg. 2009;19(3):293–298.
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Category: Past Articles, Surgical Perspective

Comments (4)

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  1. Bridget says:

    Thank you for the excellent evidence based medicene review. Have you heard anything more about insurance coverage for 2010??? I want to have the surgery but want to have it here in US , and currently would have to pay out of pocket???

  2. Cathy says:

    I agree. I found this write up by searching for evidence re the use of the laporascopic sleeve. I have been attempting a literature review including completed clinical trials regarding its use – but might not be using the search mode correctly (or clinical trials just have not been published). As far as I can find the sleeve gastrectomy is still not FDA approved.

    I have been assessed at my local Center of excellence for bariatric surgery and my surgeon has recommended the sleeve but we have been told by the insurance that this is still investigational (as it does not have FDA approval).

    I am in the process of appealing this decision (this is an Anthem/Blue Cross insurer). Is there a current fund of literature available as of April 2010 that might help me make the case for having my bariatric surgery as the sleeve as per my surgeon’s recommendation? By the way, this surgeon has an excellent track record among health care providers and is known for lack of surgical complications. thanks for any help in the appeal process!

  3. Amy says:

    My surgeon has recommended the sleeve to me as well. He knows that I have NC Medicaid insurance. So, I am assuming this means it is covered. I know the the Rouxe-n-Y procedure is covered by NC Medicaid. If I can’t have the sleeve paid for, then I will have the Roux-n-Y done.

  4. Brenda says:

    I, too, want to have the Sleeve Gastrectomy. My doctor is a well respected wls surgeon at Stanford University, CA. It is not up to the surgeon whether or not your insurance will cover this procedure, it’s up to the insurane company. I have Tricare Prime, and am in the process of appealing their denial. All I can say is, do your research as I am doing and send it in with your appeal letter. Hopefully, this procedure will soon become mainstream and everyone who needs it, will be approved. Victory can be achieved by many, so keep trying!