BioEnterics Intragastric Balloon: The Italian Experience with 2,515 Patients.

BACKGROUND: The temporary use of the BioEnterics Intragastric Balloon (BIB) in morbidly obesity is increasing worldwide. The aim of this study is the evaluation of the efficacy of this device in a large population, in terms of weight loss and its influence on co-morbidities. METHODS: Data were retrospectively recruited from the data-base of the Italian Collaborative Study Group for Lap-Band and BIB (GILB). After diagnostic endoscopy, the BIB was positioned and was filled with saline (500-700 ml) and methylene blue (10 ml). Patients were discharged with diet counselling ( approximately 1000 Kcal) and medical therapy. The BIB was removed after 6 months. Positioning and removal were performed under conscious or unconscious sedation. Mortality, complications, BMI, %EWL, BMI loss and co-morbidities were evaluated. RESULTS: From May 2000 to September 2004, 2,515 patients underwent BIB (722M/1,793F; mean age 38.9+/-14.7, range 12-71; mean BMI 44.4+/-7.8 kg/m(2) ; range 28.0-79.1; and mean excess weight 59.5+/-29.8 kg, range 16-210). BIB positioning was uncomplicated in all but two cases (0.08%) with acute gastric dilation treated conservatively. Overall complication rate was 70/2,515 (2.8%). Gastric perforation occurred in 5 patients (0.19%), 4 of whom had undergone previous gastric surgery: 2 died and 2 were successfully treated by laparoscopic repair after balloon removal. 19 gastric obstructions (0.76%) presented in the first week after positioning and were successfully treated by balloon removal. Balloon rupture (n=9; 0.36%) was not prevalent within any particular period of BIB treatment, and was also treated by BIB removal. Esophagitis (n=32; 1.27%) and gastric ulcer (n=5; 0.2%) presented in patients without a history of peptic disease and were treated conservatively by drugs. Preoperative co-morbidities were diagnosed in 1,394/2,471 patients (56.4%); these resolved in 617/1,394 (44.3%), improved (less pharmacological dosage or shift to other therapies) in 625/1,394 (44.8%), and were unchanged in 152/1,394 (10.9%). After 6 months, mean BMI was 35.4+/-11.8 kg/m(2) (range 24-73) and %EWL was 33.9+/-18.7 (range 0-87). BMI loss was 4.9+/-12.7 kg/m(2) (range 0-25). CONCLUSIONS: BIB is an effective procedure with satisfactory weight loss and improvement in co-morbidities after 6 months. Previous gastric surgery is a contraindication to BIB placement.

[Evaluation of the results after 5 year from a vertical banded gastroplasty: our experience]. / Risultati a 5 anni della gastroplastica verticale secondo MacLean: nostra esperienza.

BACKGROUND AND AIMS: vertical banded gastroplasty (GPV) is the most frequently performed restrictive procedure for morbid obesity, but long-term follow-up is almost nonexistent. A poor outcome after GPV and a low quality of life has been reported. The aim of the study was to determine long-term outcome after 5 years follow-up. METHODS: 225 GPV were performed from 1995 to 2002. Patients were followed every month in the first three months, after 6 and 12 months, and subsequently every year. RESULTS: No mortality was observed. One gastric fistula, treated with medical therapy, was the single related complication observed. Vomiting occurred in 21.2% of patients. After 2 years 74.5% of patients had a BMI < 35, with a decrease of IEW = 50% (IEW% L 54.1%, 56.4%, and 57.1% after 12, 24 and 60 months, respectively). After 5 years, the results were unsatisfactory in 17.1% of patients; 8 patients underwent bariatric re-operation with good results. CONCLUSIONS: GPV represents a safe procedure with a low incidence of complications, with poor results in 17.1% of patients. Pre-operative identification of non responders is achievable with "BIB test". In the responders significant dietary changes are complained.

[Billiopancreatic diversion with preservation of the duodenal bulb and transitory gastroplasty in the treatment of morbid obesity. Our experience]. / La diversione bilio-pancreatica con conservazione del bulbo duodenale e gastroplastica transitoria nel trattamento dell'obesità patologica. Nostra esperienza.

We present our experience in malabsorbitive procedure in bariatric surgery based on Biliopancreatic Diversion (BPD) with transitory gastroplasty. Since 1995 we operated on 74 patients with BPD coupled with gastroplasty which is transitory due to the presence of a band in polidioxanone (PDS). The technique, proposed by Vassallo et al. in 1992, involve the respect of the duodenal bulb (5 centimeter from the pylorous) making an end-to-side duodeno-ileal isoperistaltic anastomosis. The initial excess weight loss was satisfactory (69.8% +/- 11.4% after 1 year) and it kept being stable during all the follow-up (75.2% +/- 6.4% after 5 years). The mortality was absence. We didn't observe ipoalbuminemia, diarrhea or halitosis in any patients. Only 1 patient (1.3%) developed an anastomotic ulcer. After 5 years follow-up we observed 2 cases (12.5%) of chronic hypochromic anemia and 1 case (6.2%) of hypocalcemia. We didn't perform any restorative operation. We consider this technique a good malabsortive procedure able to obtain a satisfactory and stable weight loss, with a low incidence of complications. Moreover it could be applied in patients previously treated by an ineffective gastroplasty.

[Treatment of chronic critical ischemia of the lower limbs with spinal cord electrostimulation]. / Il trattamento dell'ischemia critica cronica degli arti inferiori con elettrostimolazione midollare.

The treatment of Fontaine's third and fourth stage chronic critical lower limb ischemia can be considered a medical, social and economic problem. One current form of therapeutic intervention in some cases is medullary electrostimulation (SCS: spinal cord stimulator). This study looks at the period from January 1998 to December 1997 in which patients were selected for an etiological and symptomatological examination. The criteria established at the European Consensus Conference on Critical Leg Ischemia were employed to perform medullary electrostimulation. The entire procedure included a trial period with a temporary implant and if considered tolerable and effective, a permanent implant. One hundred sixty-four patients (117 male and 46 female, aged 41-93) affected by peripheral obstructive arteriopathy were examined. Etiological causes included atherosclerosis (70.7%), diabetes or other atherosclerotic diseases (25%), inflammatory arteriopathy (1.8%) and chronic renal failure under dialysis treatment (2.4%). The procedure was successful in 103 patients (62.8%) while unsuccessful in 61 (37.2%). The best results were obtained in patients at the Fontaine's 3rd stage in which the limb was saved in 72.2% of the patients and at the beginning of the 4th stage with a success rate of 62.7%. The advanced 4th stage had a success rate of only 42.4%. From an etiological point of view, the rate of limb preservation for atherosclerosis patients was 68.1%, in diabetics 56% and inflammatory diseases 33%. However, no positive results were obtained in patients with chronic renal failure.

[Resection surgery in malignant neoplasms of the exocrine pancreas: our experience, 1987-1994]. / La chirurgia resettiva nelle neoplasie maligne del pancreas esocrino: nostra esperienza 1987-1994.

From 1987 to 1994, 24 patients underwent resection for pancreatic cancer; they represented 24% of all patients observed in that period. Surgical procedures were a pancreatoduodenectomy (PD) in 20 cases, a distal pancreatectomy in 4 cases, a palliative intervention in 61 cases, an exploratory laparotomy in 13 cases and a video laparoscopy in 2 cases. Adjuvant treatments were given in addition to resection in 20 patients. In the 20 patients undergoing PD, mortality was 20% and morbidity 20%. There was no mortality and no morbidity in distal pancreatectomy. The 1-year survival in pancreatoduodenectomy was 50% and 0% for distal pancreatectomy. Pancreatic resection, radical and palliative, whenever technically possible, represents the treatment of choice for pancreatic cancer.