Miller K,  Hell E, Lang B, Lengauer E. Gallstone Formation Prophylaxis following Gastric Restrictive Procedures for Weight Loss: A Randomized Doubleblind Placebo Controlled Trial. Ann Surg 2003 (Accepted for Publication)

Background & Aims: Rapid weight loss following surgery for the treatment of morbid obesity is associated with a high incidence of gallstone formation. This long term follow- up study was designed to determine if a 6-month regimen of prophylactic ursodesoxycholic acid is effective in the prevention of gallstones. Methods: Patients with vertical banded gastroplasty (VBG) and adjustable gastric banding (AGB) were enrolled in this study. A single center, randomized, doubleblind, prospective trial evaluated 500 mg of ursodesoxycholic acid versus placebo beginning within 3 days after surgery and continuing for 6 months or until gallstone development, for patients with morbid obesity. Transabdominal sonography or abdominal CT-scan was obtained preoperatively, at 3, 6, 12 and 24 months following surgery, or until gallstone formation. Results: From March 1997 to April 2000, 262 patients were submitted to surgery. 77 Patients refused to participate in the study, 43 patients with previous gallstone operation or verified gallstones preoperatively were excluded. Of 152 patients, 76 were randomized to placebo and 76 to 500 mg ursodesoxycholic acid daily. Preoperative age, sex, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation was significantly less (p=0,0018, Fisher exact) frequent with ursodesoxycholic acid than with placebo at 12 months, 3 % vs. 22%, and 8 % vs. 30 % (p=0,0022) at 24 months, cholecystectomy in 4,7 % vs. 12%, respectively (p< 0,02, Fisher exact). Conclusion: A daily dose of 500 mg ursodesoxycholic acid for 6 months is effective prophylaxis for gallstone formation following gastric restrictive procedures.

Franz Krempler¹, Harald Esterbauer², Raimund Weitgasser³, Christoph Ebenbichler⁴, Josef R. Patsch⁴, Karl Miller⁵, Mingqiang Xie², Veronika Linnemayr², Hannes Oberkofler², and Wolfgang Patsch² A Functional Polymorphism in the Promoter of UCP2 Enhances Obesity Risk but Reduces Type 2 Diabetes Risk in Obese Middle-Aged Humans Diabetes 2002;  51:3331-3335

Obesity is frequently associated with type 2 diabetes. We previously observed an association of a functional G/A polymorphism in the uncoupling protein 2 (UCP2) promoter with obesity. The wild-type G allele was associated with reduced adipose tissue mRNA expression in vivo, reduced transcriptional activity in vitro, and increased risk of obesity. On the other hand, studies in animal and cell culture models identified pancreatic ß-cell UCP2 expression as a main determinant of the insulin secretory response to glucose. We therefore ascertained associations of the -866G/A polymorphism with ß-cell function and diabetes risk in obesity. We show here that the pancreatic transcription factor PAX6 preferentially binds to and more effectively trans activates the variant than the wild-type UCP2 promoter allele in the ß-cell line INS1-E. By studying 39 obese nondiabetic humans, we observed genotype differences in ß-cell function; wild-type subjects displayed a greater disposition index (the product of insulin sensitivity and acute insulin response to glucose) than subjects with the variant allele (P < 0.03). By comparing obese subjects with and without type 2 diabetes, we observed genotype-associated differences in diabetes prevalence that translated into a twofold age-adjusted risk reduction in wild-type subjects. Thus, the more common UCP2 promoter G allele, while being conducive for obesity, affords relative protection against type 2 diabetes.

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Miller KA. Implantable electrical gastric stimulation to treat morbid obesity in the human: operative technique. Obes Surg 2002 Apr;12 Suppl 1:17S-20S

BACKGROUND: The surgery to place the implantable gastric stimulator (IGS) is described. METHODS: There are two implantable components to the IGS. One is the electrical stimulator itself, which is placed in the anterior abdominal wall. It is connected to a bipolar lead that is positioned in the muscle wall of the stomach. We describe the procedure that is necessary to safely place the components. RESULTS: 4 patients have been implanted using techniques that were developed and refined around the world. There were no operative deaths. All procedures were successfully completed laparoscopically. Two (2/4) connections required revision because the leads were not fully inserted into the header of the generator. CONCLUSIONS: The operation to implant the IGS is safe and simple to perform. Attention to technical details is essential.

Hell E, Miller KA, Moorehead MK, Norman S. Evaluation of health status and quality of life after bariatric surgery: comparison of standard Roux-en-Y gastric bypass, vertical banded gastroplasty and laparoscopic adjustable silicone gastric banding. Obes Surg 2000 Jun;10(3):214-9

BACKGROUND: This study is a trial to compare the effects and outcomes of three different bariatric procedures performed in two centers. Standard Roux-en-Y gastric bypass was performed by Dr. Norman Samuels in Fort Lauderdale (Florida); vertical banded gastroplasty and laparoscopic adjustable silicone gastric banding were done in Hallein (Salzburg) by Dr. Emanuel Hell and Dr. Karl Miller. METHODS: In a prospective comparative study 30 matched patients from each group were followed to assess post-operative improvement in health status and quality of life, to compare the three different techniques. The Bariatric Analysis and Reporting Outcome System (BAROS) as described by Oria and Moorehead has been used for evaluation. RESULTS: The observation time was at least 3 years (3 to 8 years) in each individual case. A significant increase in quality of life and health status in 75% of the surgically-treated patients was observed when compared with a non-operated control group of morbidly obese patients. CONCLUSIONS: By utilizing BAROS it has been found possible to compare the results of different procedures done by different surgeons with different techniques, utilizing patients from different cultures and with different languages. The results of this comparative study favor the standard gastric bypass for the treatment of morbid obesity. This operation is superior to purely gastric restrictive procedures in weight loss and improvement of quality of life.

Miller K, Hell E. Laparoscopic adjustable gastric banding: a prospective 4-year follow-up study. Obes Surg 1999 Apr;9(2):183-7

BACKGROUND: A body mass index of > or =40 kg/m2 represents clinically severe obesity and warrants operative treatment if requested. The adjustable silicone gastric band and the Swedish adjustable gastric band are recently produced laparoscopic gastric restrictive devices. The aim of this study was to assess all complications linked to both the available gastric bands in a long-term follow-up. METHODS: In a prospective study, the effects, complications, and outcomes of this procedure were analyzed. The complications found were divided into early and general complications, and complications correlated to the bands. The technique of laparoscopic adjustable gastric banding is described. Follow-up was performed by the operating team. RESULTS: Between July 1994 and August 1998, the authors operated on 158 patients and performed 102 adjustable silicone gastric bandings and 54 Swedish adjustable gastric bandings. The mean age at surgery was 36 years (range 17-72). The mean preoperative weight was 136 kg (89-230). Of 158 patients who underwent laparoscopic procedures, 156 (98%) could be followed up (mean 28 months; duration of follow-up, 6 weeks to 46 months). In early postoperative complications that required operation, one trocar wound hematoma (0.6%) and one wound infection of the port site (0.6%) were observed. The late complications that required reoperation were two pouch dilatations (1.3%), three band leakages (2%), one band migration (0.6%), and one late infection of the port (0.6%). A debanding operation was necessary in one patient because of esophageal dysmotility disorder. No early or late postoperative mortality was registered. The overall reoperation rate is currently about 7%. CONCLUSION: The operation is safe and effective. Moreover, adjustable gastric banding is fully reversible and is adjustable to the patient's needs. This study verifies the importance of correct operating technique. The authors' study and experience clearly indicate that laparoscopic adjustable gastric banding is an attractive alternative in the surgical treatment of morbid obesity.

Miller K, Rettenbecher L, Hell E. Adjustments and Leak Detection of the Adjustable Silicone Gastric Band (ASGB) and Lap-Bandtrade mark Adjustable Gastric Band (LAGB) System. Obes Surg 1996 Oct;6(5):406-411

BACKGROUND: The detection of a leakage in the system of the adjustable silicone gastric band (ASGB) may be difficult. Gastrografin injection into the port should be avoided because it acts like a glue and blocks the system. METHODS: A syringe containing saline and a syringe containing Thallium-201 chloride is connected to the 4-way stopcock which is connected to the needle. The needle is pushed into the port. The position is confirmed by injection and aspiration of saline. 2 ml of TL-201 chloride (74 MBp) is injected to locate the leakage in the system with planar images with a gamma camera (Elscint SP 6), 30 min, 2, 3, and 24 h after injection. RESULTS: The original ASGB was provided with an injection reservoir which, in our series, was found to be leaking in four cases (3%). CONCLUSIONS: Our technique for adjustment and leak detection appears to be simple and effective. Band-related problems such as reservoir leak should disappear with improvement of the material.

Miller K, Lang B, Hell E. Local vs Systemic Antibiotics to Decrease Wound Complications following Vertical Banded Gastroplasty: Results of a Prospective Randomized Trial. Obes Surg 1995 Aug;5(3):293-297

BACKGROUND: Obesity is generally regarded as one factor predisposing to wound infection. Most reports of infection rates range from I to 16% for similar procedures. In our department the wound infection rate for morbidly obese patients was 12% without perioperative antibiotics. METHODS: In a prospective randomized study we compared local gentamicin-collagen fleece application in the subcutaneous layer with patients receiving a perioperative single I.V. dose of amoxicillin-clavulanic acid 2.2 g. We examined the results of different perioperative management of antibiotics on 50 morbidly obese patients who underwent vertical banded gastroplasty from March 1993 to August 1994. The fascial, subcutaneous and skin closure technique were identical in the two groups. For both groups we used a closed-suction system to drain the bottom of the deep subcutaneous layer. On the third postoperative day, the subcutaneous drains were removed. Patients stayed in hospital an average of 10 days. They had follow-up visits after 1, 3 and 6 months, and then yearly. RESULTS: None of the 50 patients developed a wound infection, hematoma, or seroma in the hospital. During the follow-up (median 6 months), no patient developed a wound abscess. CONCLUSIONS: We believe that perioperative antibiotic management is an important factor in obtaining a low infection rate.