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

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.

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Category: Past Articles, Review