Literature DB >> 16197790

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

A Genco1, T Bruni, S B Doldi, P Forestieri, M Marino, L Busetto, C Giardiello, L Angrisani, L Pecchioli, P Stornelli, F Puglisi, M Alkilani, A Nigri, N Di Lorenzo, F Furbetta, A Cascardo, M Cipriano, M Lorenzo, N Basso.   

Abstract

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.

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Mesh:

Year:  2005        PMID: 16197790     DOI: 10.1381/0960892055002202

Source DB:  PubMed          Journal:  Obes Surg        ISSN: 0960-8923            Impact factor:   4.129


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Review 9.  Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis.

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10.  Multi-centre European experience with intragastric balloon in overweight populations: 13 years of experience.

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