Heliosphere Bag in the treatment of severe obesity: preliminary experience.

BACKGROUND: Various intragastric balloons have been used in obese patients for temporary weight loss. Recently, a new balloon, the Heliosphere Bag, was proposed. In a preliminary study, we evaluated the safety and efficacy of this device. METHODS: The Heliosphere Bag was used in 10 patients, selected according to the guidelines for obesity surgery. The manufacturer's instructions were followed in positioning the device. Heliosphere Bag positioning was performed, after diagnostic endoscopy, under unconscious sedation. After placement, the balloon was slowly inflated with 840-960 cc of air, which gives the inflated final volume of 650-700 cc of air, as the air is compressed. On the first and second post-treatment day, intravenous saline (30-35 ml/kg/d) with omeprazole (20 mg/d), ondansetron (8 mg/d) and butylscopolamine bromide (20 mg t.i.d.) were given to all patients. All patients from day 3 after placement began liquid diet and were discharged home on day 4 on a 1000 kcal diet (carbohydrate 146 g, lipid 68 g, protein 1 g/kg ideal weight). After 6 months, the Heliosphere Bag was removed. The patients were followed monthly, and complications and their treatment, post-placement symptoms, BMI and %EWL were recorded. Data were expressed as mean +/- SD. RESULTS: From Sept-Dec 2004, 10 patients (5M/5F) underwent Heliosphere Bag placement, with age 35.2 +/- 15.7 years (17-49), BMI 43.3 +/- 8.1 kg/m(2) (35-51.2), and weight 126.8 +/- 23.7 kg (98.4-148). Heliosphere Bag positioning was quite difficult in all patients due to low pliancy and large size of the bag, causing patient discomfort. System failure at time of Heliosphere Bag positioning was observed in 5/10 patients (50%). At time of removal, the Heliosphere Bag was not found in the stomach in one patient. In 3 other patients, the balloon was found partially deflated. At the time of balloon removal after 6 months, BMI was 37.4 +/- 13.4 (28.9-42.1) and %EWL was 29.1 +/- 20.1 (9.0-57.4). BMI loss was 5.2 +/- 13.1 (1.9-11.2) and mean weight loss was 17.5 +/- 16.2 kg (5-33). CONCLUSIONS: Although weight loss was satisfactory, this device cannot be considered an advance for the temporary treatment of morbid obesity. This balloon still has some instrumental and technical problems that need to be solved: high rate of system failure at positioning, high rate of spontaneous deflation, absence of a marker such as methylene blue, and large size with low pliability that cause significant patient discomfort.

Laparotomic vs laparoscopic lap-band: 4-year results with early and intermediate complications.

BACKGROUND: Adjustable banding is safe, low invasive, and effective for losing weight. METHODS: 69 patients underwent this procedure by laparotomy or laparoscopy. RESULTS: Patients operated by laparotomy lost more weight than those operated by laparoscopy, but in 4 patients we were forced to re-operate in order to remove the band (3 pouch dilatations and 1 stomach slippage), and in 9 patients a ventral hernia appeared (5 patients repaired). In the laparoscopic cases there were 4 intra-operative gastric perforations, but all were repaired and the band placed at the same time (3 conversions to open), causing an increased post-operative hospital stay. There was a lower limb deep venous thromboembolism, which was followed by fatal pulmonary embolism (although the patient had been given heparin and had been treated with elastocompression and mobilization 2 hours after surgery). The band eroded in one patient. Weight losses in these morbidly obese patients were satisfactory at 2 years and maintained beyond 3 years. CONCLUSION: Laparoscopic adjustable banding is an efficient, generally safe procedure.

Two years of practice in adjustable silicone gastric banding (LAP-BAND): evaluation of variations of body mass index, percentage ideal body weight and percentage excess body weight.

BACKGROUND: In the treatment of morbid obesity, surgery had been the only method of obtaining a good and enduring weight loss. Although the procedure of choice is still a matter of debate, among gastric restriction procedures LAP-BAND has become our first choice. METHODS: We report the results from 62 morbidly obese patients operated in the period October 1994-December 1996. Their characteristics were: mean age 35.6 years, mean body weight 130.6 kg, mean height 162.3 cm, mean body mass index (BMI) 49.9 kg/m2, mean percentage ideal body weight (%IBW) 215.7 and mean excess weight (EW) 69.57 kg. RESULTS: Twenty-four months after surgery we found a mean BMI of 39.3, a mean %IBW of 168.6 and a mean % EW loss of 88.5. We removed the band in two patients: one after 9 months because of stoma stenosis and pouch enlargement in a woman who had been lost at follow-up, and the other for gastric slippage occurring after 18 months due to incorrect fixation of the band. CONCLUSION: Our results led us to consider LAP-BAND as the surgical approach for severe obesity among those patients selected for gastric restriction; indeed, it was very safe as well as effective and was rarely followed by complications.

To assess the efficacy of prophylaxis in digestive tract surgery using a predictive model of complication risk.

One hundred and ninety-one patients, all candidates for major clean-contaminated surgery, were classified according to the risk of developing postoperative wound infection, using clinical and nutritional factors. A widely validated nutritional assessment model, the Prognostic Nutritional Index (PNI), was used preoperatively to evaluate the risk and probability of post-operative septic complications. Based on the predicted outcome, patients were assigned to either a poor or a good risk group for statistical comparison. A prospective, double-blind, randomized trial was performed to compare the effectiveness of the monocyclic beta-lactam, aztreonam, with gentamicin for short-term perioperative prophylaxis. In the poor risk group (PNI greater than 40), aztreonam prophylaxis significantly reduced postoperative septic complications (p less than 0.05). The use of an objective scoring system to assess the risk of postoperative sepsis is recommended for future studies on antibiotic prophylaxis as it offers a realistic assessment basis.

Chemoprophylaxis in clean-contaminated surgery.

Prophylaxis should be restricted to operations for which its benefit has been established. These are mainly operations in which a viscus colonized by bacteria is opened and in which bacterial contamination is unavoidable. The most important principle is to ensure adequate blood levels of antibiotic at the time of surgery. The choice of antibiotic should be based on knowledge of bacteria likely to cause infection.

Chemoprophylaxis in the surgical ward: results of a national survey in Italy.

As part of a national program for the control of hospital acquired infections, a survey on the use of antibiotic chemoprophylaxis was conducted in 1050 public hospitals in Italy (95% of the total number of hospitals in the country). In each hospital, the chief of the general surgery ward was interviewed by means of a standard mail questionnaire. Answers were obtained from 479 surgeons (45.6%) after two mailings. More than 60% of these reported that they used chemoprophylaxis in clean surgery (mastectomy, splenectomy, hernioplasty). More than 80% used antibiotic prophylaxis in surgery in which antimicrobial prophylaxis is facultative (i.e. elective cholecystectomy, gastric resection), and 97.1% used antibiotic prophylaxis in large bowel surgery. The authors recorded starting times and duration of chemoprophylaxis. Cephalosporins were found to be the most commonly used antibiotics followed by penicillin.

First full blown syndrome of acute zinc deficiency in course of long term total parenteral nutrition: a clinical case.

The case of a surgical patient with a full blown syndrome of zinc deficiency is presented and the various implications related to a deficiency of this trace mineral are discussed. The symptomatology involved mental depression, visual disturbances, glucose intolerance, decreased serum alkaline phosphatase levels, wound healing impairment, eczematoid dermatitis and reduced humoral and cellular immune defences. Oral supplementation with zinc sulphate dramatically reversed the signs and symptoms of the syndrome and resulted in rapid wound healing. This case seems to have exhibited most of the different signs and symptoms reported from time to time in the literature. Awareness of zinc deficiency is being brought to light in many medical and surgical conditions. Total parenteral nutrition (T.P.N.) can exacerbate the lack of this trace metal and supplementation with fresh blood derivate are, as demonstrated, useless in these cases. Zinc, as component of various metalloenzymes, accounts for the clinical manifestations of its deficiency.

Solitary necrotic nodule of the liver misinterpreted as malignant lesion: considerations on two cases.

In our experience, we document 2 cases of a rare and non-tumoral lesion of the liver misinterpreted as necrotic tumor: necrotic solitary nodule. In the first clinical case, ultrasound (US) showed a polylobated lesion (35 x 35 x 38 mm) at segment 8. Color-doppler identified a compression of celiac axis (Dunbar syndrome). Arteriography revealed a subtotal stenosis of celiac tripod soon after the emergence of the left gastric artery. FNAB-CT showed a highly cellulated tissue with a necrotic core surrounded by a fibersclerotic tissue. The patient underwent surgery: cholecystectomy and correction of Dunbar syndrome. US follow-up showed a progressive reduction in diameter of the lesion (24 x 25 x 25 mm at 24 months), suggesting in this case the role of ischemic injury in the pathogenesis of the lesion. In the second clinical case, a hypoechoic lesion (32 x 32 x 30 mm) of segment 6 as occasional US finding during the staging for prostate cancer was shown. FNAC-CT showed a positive result for necrotic cells. Surgical treatment consisted in a wide excision of the lesion. Histologically the lesion was solitary necrotic nodule. The diagnosis of this rare lesion is accidental. In accordance with the literature (50% of cases), we founded an associated tumor. Radiology doesn't differentiate solitary necrotic nodule and other solid lesions. Diagnosis is histological (in our second case, FNAC-CT misinterpreted the tumor as a malignant lesion, while histology showed the real nature of it).