From 1990 to 1993, the ILOST team performed 255 "open" gastric banding procedures using the first generation Adjustable Silicone Gastric Banding System (Kuzmak), Inamed Development. In October 1992, we first developed and used the minimally invasive, laparoscopic approach. Changes were made to the gastric banding device originally developed by Dr. Kuzmak in order to make it suitable for the laparoscopic approach.

Between that time and November 2000, 1,500 patients (Table 1) underwent the LAP-BAND System procedure at our centers in Italy (Dr. Favretti, Obesity Center, University of Padua, Padua; Surgical Department, Regional Hospital, Vicenza), and Belgium (Dr. Cadiere, Surgical Department, Free University, Brussels). The average length of the procedure was 75 minutes (between 45 and 240 minutes).

Clinical trials conducted by BioEnterics Corporation (authorized and monitored by the FDA) were done in selected hospitals around the United States on a limited number of patients. Our team of surgeons was asked by BioEnterics Corporation to provide case documentation to the FDA in order to help accelerate approval of the surgical procedure.

Table 1
Characteristics of the average patient*
Number of patients		1,500 (78% female)
Age (yrs)		36 (18 - 65)
Body weight (kg)		126 (80 - 278)
% Above ideal body weight		204 (155 - 290)
Body Mass Index (BMI, kg/m2)		46 (35 - 65)
* Brussels and Padua series

Overall, 27% had undergone abdominal surgery previously. Patients also had the following co-morbidities: inflammation of the esophagus (12%), arterial hypertension (7%), type II diabetes (18%), sleep apnea syndrome (14%), hiatal hernia (11%), and painful arthritis or joint pain (7%). In only 1.6% of the cases, the laparoscopic procedure had to be stopped and converted to conventional surgery (table 2).

Table 2
Reasons for conversion from laparoscopy to standard surgery*
Risky perigastric dissection	0.9 % (laparoscopic inoperability because of the size of the left liver lobe)
instrument inadequacy	0.1 %
perforation of the stomach	0.4 %
band malpositioning	0.1 %
bleeding	0.1 %
Total	1.6 %
* Brussels and Padua series

Our group has reported the lowest rate of complications with gastric banding using the laparoscopic approach. Among 830 patients in Padua, only 33 (3.9%) had serious complications requiring reoperation (table 3). There were no complications due to wound healing and blood clotting in lungs (pulmonary embolism) or deep veins (deep venous thrombosis) did not occur. No deaths were reported.

Table 3
Major complications requiring re-operation**
	Type	Incidence
Early	gastric perforation (removal of band)	1 (0.12%)
	stomach slippage (repositioning)	1 (0.12%)
Late	stomach slippage (5 repositioned, 3 removed)	17 (2.0%)
	erosion of band (removal)	4 (0.48%)
	psychological intolerance (removal)	3 (0.36%)
Total		33 (3.9%)
** Padua series

Minor complications requiring additional surgery with a local anesthetic included twisting of the subcutaneous reservoir, breaking of the subcutaneous connecting tube and infection of the reservoir.

Table 4
Weight Loss Results from the Padua Data
Year	0	1	2	3	4	5	6	7
Number of Patients	830	680	479	305	185	74	24	3
Body Weight (kg)	128	104	96	94	90	88	87	85
Body Mass Index (kg/m2)	46.5	38	35	34	34	33	33	32
% Excess Weight Loss	---	36	46	49	49	55	53	53