Implementing an Evidence-based Approach to Selection of Type of Laparoscopic Bariatric Surgery

| July 14, 2009

by Geoffrey P. Kohn, MBBS, FRACS; Stephen P. Haggerty, MD, FACS; D. Wayne Overby, MD; Robert D. Fanelli, MD, FACS, FASGE; and Timothy M. Farrell, MD, FACS

Drs. Kohn, Overby, and Farrell are from the Department of Surgery, University of North Carolina at Chapel Hill, North Carolina; Dr. Haggerty is from the Department of Surgery, North Shore University Health System, Evanston, Illinois; and Dr. Fanelli is from the Department of Surgery, Berkshire Medical Center, Pittsfield, Massachusetts.

Introduction
Obesity may be the most significant disease epidemic affecting Western nations in the 21st century. Morbid obesity and its associated comorbidities threaten the lives of millions of Americans. However, medical therapies have been demonstrated to not achieve persisting weight loss or comorbidity resolution. Three minimally invasive surgical procedures have emerged as viable treatment options for morbid obesity—Roux-en-Y gastric bypass (RGB), adjustable gastric banding (AGB), and biliopancreatic diversion with duodenal switch (BPD-DS), though there remains a marked paucity of comparative data.

We participated in developing the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Guideline for Clinical Application of Bariatric Surgery, and in doing so reviewed the literature and made best-evidence recommendations to allow selection of the type of bariatric operation most appropriate to specific patients’ requirements.[1] This article summarizes our clinical practice guideline.

A search of the literature was performed, using both electronic and physical resources. Inclusion of a study required focus on at least one of the following categories of information: surgical outcomes, guidelines, healthcare economics, or quality of life. Search terms used were therefore combinations of obesity surgery, bariatric surgery, gastric bypass, gastroplasty, gastric band, biliopancreatic diversion, duodenal switch, sleeve gastrectomy, reoperation, revision, laparoscopic, diabetes, hypertension, hyperlipidemia, sleep apnea, nutrition, and complications.

Manual reference checks of published review articles were performed to supplement the above electronic searches. The articles were graded on level of evidence and recommendations were made.

Summary of the Evidence Collected by Operation
Laparoscopic RGB. Outcomes. Laparoscopic RGB is the most commonly performed bariatric operation in the United States, and its incidence is rising exponentially.[2,3] The operation in its present form, with a 30cc pouch and a 75 to 150cm Roux limb length, is highly reproducible and well suited for a minimally invasive approach. The literature comparing laparoscopic RGB to open RGB and to contemporary medical and surgical treatments for obesity includes several prospective, randomized, controlled trials,[4-11] a large, prospective, case-controlled cohort study,[12] numerous case series, and four meta-analyses.[13-16] Open and laparoscopic RGB have similar efficacy. In prospective randomized trials,[5-7,10] there are no significant differences in weight loss up to three-year followup. Similar results have been reported in case series.[16] Patients who undergo laparoscopic RGB typically experience 60- to 70-percent excess weight loss (%EWL), with greater than 75-percent control of comorbidities.[12–15] In general, as shown in Table 1, results of these outcome measures are better after RGB than after banding procedures, which have 45 to 50 %EWL and less predictable improvement of comorbidities, but are lower than with BPD-DS, which results in 70 to 80 %EWL with slightly better control of comorbidities.[15] Much of the appeal of RGB is that it is a combined restrictive and malabsorptive procedure that bypasses the foregut and offers a more significant improvement in type 2 diabetes than AGB, which relies solely on weight loss.[17] A similar effect is seen after BPD-DS, but that operation has the potential for more severe metabolic consequences and steatorrhea.[18–21]

Complications. The mortality rate after RGB ranges from 0.3 percent in case series to 1.0 percent in controlled trials, and the rate of preventable and nonpreventable adverse surgical events is 18.7 percent.[14] The mortality rate in a review of selected laparoscopic RGB series ranged from 0.5 percent to 1.1 percent.[22] Safety of laparoscopic RGB has been compared to open RGB, with laparoscopic patients having reduced incidence of splenectomy secondary to iatrogenic injury, wound infection, incisional hernia and perioperative mortality, but higher rates of bowel obstruction, intestinal hemorrhage, and stomal stenosis.[23] The most frequently reported perioperative complications associated with laparoscopic RGB are wound infection (3%), anastomotic leak (2.1%), gastrointestinal tract hemorrhage (1.9%), bowel obstruction (1.7%), and pulmonary embolus (0.4%), while the most frequently reported late complications are stomal stenosis (4.7%), bowel obstruction (3.2%), and incisional hernia (0.5%).[23] Table 2 uses morbidity and mortality data from multicenter trials to show AGB to be the safest, while BPD-DS is the most risky.

Laparoscopic AGB. Outcomes. Laparoscopic AGB is very effective at producing weight loss, with patients losing approximately 50 percent of excess body weight.[15, 24] The weight loss occurs in a gradual manner, with approximately 35 %EWL by six months, 40 percent by 12 months, and 50 percent by 24 months. This percentage appears to remain stable after 3 to 8 years based on the few studies providing this length of followup;[25–28] however, as many as 25 percent of laparoscopic AGB patients fail to lose 50 percent of their excess body weight by five years postoperation.[15, 29]

Type 2 diabetes mellitus is improved in about 90 percent of patients,[30] and diabetic medications are eliminated in 64 percent.[30,31] Gastroesophageal reflux disease may be eliminated in at least 89 percent at 12 months, even in patients with large hiatus hernias,[32,33] but with the side effect of impaired lower esophageal sphincter relaxation and possible altered esophageal motility.[34] The rate of obstructive sleep apnea drops from 33 percent to two percent in laparoscopic AGB patients.[35]

Major quality of life improvements are seen after AGB placement, with all subscales of the SF-36 general quality of life questionnaire significantly improved, particularly in areas of bodily pain, general health perception, and mental health perception.[36–38] The short-term (<12 months) weight loss of laparoscopic AGB is inferior to RGB.[39] This discrepancy is seen to continue, with a randomized, controlled trial illustrating that EBWL at five years was 47.5 percent for AGB versus 66.6 percent for RGB.[40] Still, life-threatening complications are less frequent in laparoscopic AGB as compared to laparoscopic RGB.

Complications. Case series and systematic reviews put early mortality rates after laparoscopic AGB at 0.05 to 0.4 percent[15,41] compared with laparoscopic RGB at 0.5 to 1.1 percent,22 open RGB at 0.5 to 1.0 percent,[14,15] open BPD at 1.1 percent,[15,42] and laparoscopic BPD at 2.5 to 7.6 percent.[43–45]

Regarding relative morbidity rates, comparative data are few. Overall complications and major complications are less common in laparoscopic AGB than laparoscopic RGB or laparoscopic BPD-DS in a single-center experience.[46] Laparoscopic AGB placement shares some of the perioperative complications of other bariatric operations, with gastrointestinal perforation (1%) and other visceral injury (1%) being the most common. In addition, band-specific complications are frequently reported,[36] with three-year data approximating 30 percent for gastric prolapse, five percent for esophageal dilatation, and 10 percent for stomal obstruction.

Complications requiring AGB explantation or major revision occur in up to 33 percent by nine years of follow up.[47,48] Port-site complications, including pain, port displacement, and leak, arise in about seven percent of patients.

BPD-DS. Outcomes. BPD-DS results in dramatic weight loss during the first 12 postoperative months, which continues at a slower rate over the next six months. Weight loss is durable up to at least five years postoperatively. Ninety-five percent of patients with BMIs less than 50kg/m2 and 70 percent of those with BMI greater than 50kg/m2 achieve greater than 50-percent excess body weight loss.[19,49,50] Weight may be regained over time,[42] highlighting the importance of long-term follow-up.

BPD-DS dramatically impacts comorbidities. At least 90 percent of patients with type-2 diabetes will cease to need diabetic medications by 12 to 36 months.[51–53] Fifty to 80 percent of hypertensive patients will be cured, with another 10 percent experiencing improvement.[54–56] Up to 98 percent of patients with obstructive sleep apnea will experience symptom resolution.[57,58]

Although BPD-DS, RGB, and AGB are all superior to nonsurgical therapy, the relative effectiveness of these procedures has not been fully compared. Available data are rarely randomized or controlled and often compare nonequivalent cohorts. Nonetheless, available data suggest the weight loss effect of BPD-DS is greater and more durable than laparoscopic AGB.[25,57] Likewise, BPD may be superior to RGB in patients with BMI greater than or equal to 50kg/m2.[59]

A meta-analysis examining studies published between 1990 and 2003 found BPD-DS resulted in more weight loss and improvement of diabetes, hyperlipidemia, hypercholesterolemia, hypertriglyceridemia, and obstructive sleep apnea than any other type of bariatric procedure.[15] Despite the favorable reports on the use of the duodenal switch procedure for the treatment of morbid obesity, it has been slow to gain widespread acceptance.[49]

Complications. The 30-day mortality of early laparoscopic BPD-DS series ranges from 2.6 to 7.6 percent.[43,44] Major anatomic complications, which occur in up to 25 percent of cases, may include early occurrence of anastomotic leak, duodenal stump leak, intra-abdominal infection, hemorrhage, and venous thromboembolism, [44,45,49,60,61] or later bowel obstruction, incarceration, or stricture.[46]

Although 70 to 98 percent of patients maintain normal serum albumin three years after surgery,[49,57] steatorrhea is a frequent chronic complication. Common channel length of 50cm is associated with reports of diarrhea in most patients,[57] whereas length of 100cm is not.[49] Iron deficiency is common, with serious iron deficiency anemia (hemoglobin <10mg/dL) occurring in six percent of patients.[62]

Surveillance of biochemical and hematological markers of iron deficiency should drive replacement. Calcium and Vitamin D malabsorption are also common, manifesting as secondary hyperparathyroidism.[63] Supplements do not prevent development of secondary hyperparathyroidism. Increase in bone resorption is known to occur irrespective of parathormone levels, suggesting a phenomenon of bone reshaping parallel to the loss of weight.[64] Due to fat malabsorption resulting from BPD, supplementation of fat-soluble vitamins is recommended. Deficiency of these vitamins is more likely with a shorter common channel.

Cholelithiasis occurs postoperatively in 6 to 25 percent[65,66] of patients after BPD-DS. Some surgeons advocate for routine cholecystectomy given the alteration in endoscopic accessibility to the biliary tract that increases the difficulty of treating choledocholithiasis, whereas others argue for staged cholecystectomy only if symptoms develop, since cholecystitis occurs uncommonly after BPD-DS.[67]

Conclusions
Laparoscopic RGB, AGB, and BPD-DS have all been proved effective. Laparoscopic AGB has the lowest perioperative risk and the lowest rate of metabolic complications, but the lowest potential weight loss. BPD-DS provides the highest and most durable long-term loss of excess body weight, but is the most complex and has the highest major complication and mortality rate. All procedures improve comorbidities, though BPD-DS and RGB provide the most rapid comorbidity improvement. AGB is most reversible, and RGB is the least likely to require reoperation. RGB provides patients the most autonomy from healthcare providers and is favored by most bariatric surgeons.

Presently, there is not one weight loss operation that fits all patients. The patient must be well informed and comfortable with the anatomical and lifestyle changes he or she will undergo. Furthermore, the surgeon and patient must consider risk versus benefit on an individual basis, as well as take into consideration the surgeon’s personal experience and outcomes. A flowchart ( Figure 1), intended to aid to patient and physician decision-making, has been constructed.

References
1.    SAGES guideline for clinical application of laparoscopic bariatric surgery. Surgic Endosc 2008;22(10):2281–2300.
2.    Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA. 2005;294(15):1909-17.
3.    Nguyen NT, Root J, Zainabadi K, et al. Accelerated growth of bariatric surgery with the introduction of minimally invasive surgery. Arch Surg. 2005;140(12):1198–1202; discussion 1203.
4.    Inabnet WB, Quinn T, Gagner M, et al. Laparoscopic Roux-en-Y gastric bypass in patients with BMI <50: a prospective randomized trial comparing short and long limb lengths. Obes Surg. 2005;15(1):51–57.
5.    Westling A, Gustavsson S. Laparoscopic vs open Roux-en-Y gastric bypass: a prospective, randomized trial. Obes Surg. 2001;11(3):284–292.
6.    Nguyen NT, Goldman C, Rosenquist CJ, et al. Laparoscopic versus open gastric bypass: a randomized study of outcomes, quality of life, and costs. Ann Surg. 2001;234(3):279–289; discussion 289–291.
7.    Lujan JA, Frutos MD, Hernandez Q, et al. Laparoscopic versus open gastric bypass in the treatment of morbid obesity: a randomized prospective study. Ann Surg. 2004;239(4):433–437.
8.    Lee WJ, Huang MT, Yu PJ, et al. Laparoscopic vertical banded gastroplasty and laparoscopic gastric bypass: a comparison. Obes Surg. 2004;14(5):626–634.
9.    Olbers T, Fagevik-Olsen M, Maleckas A, Lonroth H. Randomized clinical trial of laparoscopic Roux-en-Y gastric bypass versus laparoscopic vertical banded gastroplasty for obesity. Br J Surg. 2005;92(5):557–562.
10.    Puzziferri N, Austrheim-Smith IT, Wolfe BM, et al. Three-year follow-up of a prospective randomized trial comparing laparoscopic versus open gastric bypass. Ann Surg. 2006;243(2):181–188.
11.    Olbers T, Bjorkman S, Lindroos A, et al. Body composition, dietary intake, and energy expenditure after laparoscopic Roux-en-Y gastric bypass and laparoscopic vertical banded gastroplasty: a randomized clinical trial. Ann Surg. 2006;244(5):715–722.
12.    Sjostrom L, Lindroos AK, Peltonen M, et al. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004;351(26):2683–2693.
13.    Colquitt J, Clegg A, Loveman E, et al. Surgery for morbid obesity. Cochrane Database Syst Rev. 2005(4):CD003641.
14.    Maggard MA, Shugarman LR, Suttorp M, et al. Meta-analysis: surgical treatment of obesity. Ann Intern Med. 2005;142(7):547–559.
15.    Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292(14):1724–1737.
16.    Shekelle PG, Morton SC, Maglione M, et al. Pharmacological and surgical treatment of obesity. Evid Rep Technol Assess (Summ). 2004(103):1-6.
17.    Gan SS, Talbot ML, Jorgensen JO. Efficacy of surgery in the management of obesity-related type 2 diabetes mellitus. ANZ J Surg. 2007;77(11):958–962.
18.    Mason EE. Bone disease from duodenal exclusion. Obes Surg. 2000;10(6):585–586.
19.    Anthone GJ. The duodenal switch operation for morbid obesity. Surg Clin North Am. 2005;85(4):819–833, viii.
20.    Scopinaro N, Adami GF, Marinari GM, et al. Biliopancreatic diversion. World J Surg. 1998;22(9):936-46.
21.    Fabry H, Hendrickx L, Van Hee R. Blind loop syndrome after biliopancreatic diversion: a diagnostic challenge. Obes Surg. 2001;11(5):643–645.
22.    Nguyen NT, Wilson SE. Complications of antiobesity surgery. Nat Clin Pract Gastroenterol Hepatol. 2007;4(3):138–147.
23.    Podnos YD, Jimenez JC, Wilson SE, et al. Complications after laparoscopic gastric bypass: a review of 3464 cases. Arch Surg. 2003;138(9):957–961.
24.    Galvani C, Gorodner M, Moser F, et al. Laparoscopic adjustable gastric band versus laparoscopic Roux-en-Y gastric bypass: ends justify the means? Surg Endosc. 2006;20(6):934–941.
25.    O’Brien PE, McPhail T, Chaston TB, Dixon JB. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006;16(8):1032–1040.
26.    O’Brien PE, Brown WA, Smith A, et al. Prospective study of a laparoscopically placed, adjustable gastric band in the treatment of morbid obesity. Br J Surg. 1999;86(1):113–118.
27.    Angrisani L, Alkilani M, Basso N, et al. Laparoscopic Italian experience with the Lap-Band. Obes Surg. 2001;11(3):307–310.
28.    DeMaria EJ, Sugerman HJ, Meador JG, et al. High failure rate after laparoscopic adjustable silicone gastric banding for treatment of morbid obesity. Ann Surg. 2001;233(6):809–818.
29.    Angrisani L, Di Lorenzo N, Favretti F, et al. The Italian Group for LAP-BAND: predictive value of initial body mass index for weight loss after 5 years of follow-up. Surg Endosc. 2004;18(10):1524–1527.
30.    Abu-Abeid S, Keidar A, Szold A. Resolution of chronic medical conditions after laparoscopic adjustable silicone gastric banding for the treatment of morbid obesity in the elderly. Surg Endosc. 2001;15(2):132–134.
31.    Dixon JB, O’Brien PE. Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding. Diabetes Care. 2002;25(2):358–363.
32.    Dixon JB, O’Brien PE. Gastroesophageal reflux in obesity: the effect of lap-band placement. Obes Surg. 1999;9(6):527–531.
33.    Angrisani L, Iovino P, Lorenzo M, et al. Treatment of morbid obesity and gastroesophageal reflux with hiatal hernia by Lap-Band. Obes Surg. 1999;9(4):396–398.
34.    Weiss HG, Nehoda H, Labeck B, et al. Treatment of morbid obesity with laparoscopic adjustable gastric banding affects esophageal motility. Am J Surg. 2000;180(6):479–482.
35.    Dixon JB, Schachter LM, O’Brien PE. Sleep disturbance and obesity: changes following surgically induced weight loss. Arch Intern Med. 2001;161(1):102–106.
36.    Horchner R, Tuinebreijer MW, Kelder PH. Quality-of-life assessment of morbidly obese patients who have undergone a Lap-Band operation: 2-year follow-up study. Is the MOS SF-36 a useful instrument to measure quality of life in morbidly obese patients? Obes Surg. 2001;11(2):212–218; discussion 219.
37.    Weiner R, Datz M, Wagner D, Bockhorn H. Quality-of-life outcome after laparoscopic adjustable gastric banding for morbid obesity. Obes Surg. 1999;9(6):539–545.
38.    Martin LF, Smits GJ, Greenstein RJ. Treating morbid obesity with laparoscopic adjustable gastric banding. Am J Surg. 2007;194(3):333-43; discussion 344–348.
39.    O’Brien P. Outcomes of laparoscopic adjustable gastric banding. In: Sugerman HJ, Nguyen NT, eds. Management of morbid obesity: Taylor & Francis Group; 2006:181–190.
40.    Angrisani L, Lorenzo M, Borrelli V. Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 5-year results of a prospective randomized trial. Surg Obes Relat Dis. 2007;3(2):127–132; discussion 132–133.
41.    Chapman AE, Kiroff G, Game P, et al. Laparoscopic adjustable gastric banding in the treatment of obesity: a systematic literature review. Surgery. 2004;135(3):326–351.
42.    Biron S, Hould FS, Lebel S, et al. Twenty years of biliopancreatic diversion: what is the goal of the surgery? Obes Surg. 2004;14(2):160–164.
43.    Paiva D, Bernardes L, Suretti L. Laparoscopic biliopancreatic diversion: technique and initial results. Obes Surg. 2002;12(3):358–361.
44.    Kim WW, Gagner M, Kini S, et al. Laparoscopic vs. open biliopancreatic diversion with duodenal switch: a comparative study. J Gastrointest Surg. 2003;7(4):552–557.
45.    Ren CJ, Patterson E, Gagner M. Early results of laparoscopic biliopancreatic diversion with duodenal switch: a case series of 40 consecutive patients. Obes Surg. 2000;10(6):514–523; discussion 524.
46.    Parikh MS, Laker S, Weiner M, et al. Objective comparison of complications resulting from laparoscopic bariatric procedures. J Am Coll Surg. 2006;202(2):252–261.
47.    Favretti F, Segato G, Ashton D, et al. Laparoscopic adjustable gastric banding in 1,791 consecutive obese patients: 12-year results. Obes Surg. 2007;17(2):168–175.
48.    Balsiger BM, Ernst D, Giachino D, et al. Prospective evaluation and 7-year follow-up of Swedish adjustable gastric banding in adults with extreme obesity. J Gastrointest Surg. 2007;11(11):1470-6; discussion 1446-7.
49.    Marceau P, Biron S, Bourque RA, Potvin M, Hould FS, Simard S. Biliopancreatic Diversion with a New Type of Gastrectomy. Obes Surg. 1993;3(1):29-35.
50.    Anthone GJ, Lord RV, DeMeester TR, Crookes PF. The duodenal switch operation for the treatment of morbid obesity. Ann Surg. 2003;238(4):618–627; discussion 627-8.
51.    Gagner M, Matteotti R. Laparoscopic biliopancreatic diversion with duodenal switch. Surg Clin North Am. 2005;85(1):141–149, x-xi.
52.    Marinari GM, Papadia FS, Briatore L, et al. Type 2 diabetes and weight loss following biliopancreatic diversion for obesity. Obes Surg. 2006;16(11):1440–1444.
53.    Marceau P, Biron S, Hould FS, Marceau S. Changing intestinal absorption for treating obesity. In: Sugerman HJ, Nguyen NT, (eds). Management of Morbid Obesity: Philadelphia, PA: Taylor & Francis Group, 2006:153–156.
54.    Carson JL, Ruddy ME, Duff AE, et al. The effect of gastric bypass surgery on hypertension in morbidly obese patients. Arch Intern Med. 1994;154(2):193–200.
55.    Adami G, Murelli F, Carlini F, et al. Long-term effect of biliopancreatic diversion on blood pressure in hypertensive obese patients. Am J Hypertens. 2005;18(6):780–784.
56.    Adami GF, Papadia F, Carlini F, et al. Effect of biliopancreatic diversion on hypertension in severely obese patients. Hypertens Res. 2005;28(2):119–123.
57.    Dolan K, Hatzifotis M, Newbury L, Fielding G. A comparison of laparoscopic adjustable gastric banding and biliopancreatic diversion in superobesity. Obes Surg. 2004;14(2):165–169.
58.    Simard B, Turcotte H, Marceau P, et al. Asthma and sleep apnea in patients with morbid obesity: outcome after bariatric surgery. Obes Surg. 2004;14(10):1381–1388.
59.    Prachand VN, Davee RT, Alverdy JC. Duodenal switch provides superior weight loss in the super-obese (BMI ≥50kg/m2) compared with gastric bypass. Ann Surg. 2006;244(4):611–619.
60.    Hess DS, Hess DW, Oakley RS. The biliopancreatic diversion with the duodenal switch: results beyond 10 years. Obes Surg. 2005;15(3):408–416.
61.    Scopinaro N, Gianetta E, Civalleri D, et al. Two years of clinical experience with biliopancreatic bypass for obesity. Am J Clin Nutr. 1980;33(2 Suppl):506–514.
62.    Marceau P, Hould FS, Lebel S, et al. Malabsorptive obesity surgery. Surg Clin North Am. 2001;81(5):1113–1127.
63.    Chapin BL, LeMar HJ, Jr., et al. Secondary hyperparathyroidism following biliopancreatic diversion. Arch Surg. 1996;131(10):1048–1052; discussion 1053.
64.    Moreiro J, Ruiz O, Perez G, et al. Parathyroid hormone and bone marker levels in patients with morbid obesity before and after biliopancreatic diversion. Obes Surg. 2007;17(3):348–354.
65.    Michielson D, Van Hee R, Hendrickx L. Complications of biliopancreatic diversion surgery as proposed by Scopinaro in the treatment of morbid obesity. Obes Surg. 1996;6(5):416–420.
66.    Scopinaro N, Gianetta E, Civalleri D, et al. Biliopancreatic bypass for obesity: II. Initial experience in man. Br J Surg. 1979;66(9):618–620.
67.    Bardaro SJ, Gagner M, Consten E, et al. Routine cholecystectomy during laparoscopic biliopancreatic diversion with duodenal switch is not necessary. Surg Obes Relat Dis. 2007;3(5):549–553.
68.    Farrell TM, Haggerty SP, Overby DW, et al. Clinical application of laparoscopic bariatric surgery: an evidence-based review. Surg Endosc. 2009;23(5):930–949. Epub 2009 Jan 6.

Category: Patient Management Perspective

Comments are closed.