The overall long-term complication rate following SAGB is reasonable. With improved operating technique and closer follow-up, it should be possible to reduce the complication rate further. Reoperation because of band migration appears to be related to overfilling of the system and should therefore be avoidable in most cases.

This relatively simple method appears to be at least as good as the other operations, and weight loss can be adjusted to patient comfort. Currently, the procedure is being performed laparoscopically.

A new adjustable gastric band was developed, consisting of a silicone balloon connected to a subcutaneous port In a closed system. The stoma diameter can be regulated within an extensive range (0-40 mm). The diameter is adjusted individually for each patient and weight loss can therefore be controlled and optimized. We evaluated the application of this new gastric banding procedure in terms of technical feasibility, complication rate and weight loss, and also the relationship between weight loss and pouch volume. Between January 1987 and April 1990 two preliminary studies of 18 and 24 patients respectively were carried out. In the first group there were technical problems resulting in insufficient weight loss. We therefore changed the procedure. In the second group the system thereafter worked as expected. In the second group mean preoperative weight was 132 kg, mean excess weight 60 kg, and mean BMI 45. The mean follow-up was in 21 months. At follow-up mean weight was 91 kg, mean weight loss 41 kg, and mean BMI 31. The mean postoperative stay was 6.0 days. Pouch volume and stoma diameter were followed by regular ondoscopy. There was a distinct relationship between pouch volume and weight loss-the smaller the volume the greater the weight loss.

BACKGROUND: Weight loss appears to be inversely related to pouch volume following gastric restriction procedures for morbid obesity. The aim of this study was to investigate the changes in pouch volume with time and the relationship between pouch volume and stoma diameter and subsequent weight loss following the Swedish Adjustable Gastric Banding (SAGB). METHODS: During 1990 50 patients were operated upon. Their mean BMI at surgery was 46 and at 2 years 28. We followed these patients with endoscopy at 6 weeks and 3, 18 and 24 months after surgery. During endoscopy pouch volume was estimated according to a standardized classification system and measured stoma diameter using balloon catheters. RESULTS: The results indicate that the pouch dilates during the first few months after surgery but that the size thereafter is fairly stable. There is also a relationship between pouch volume and subsequent weight loss. Pouch volume seems to be the primary determinator for weight loss. CONCLUSION: The smaller the pouch the greater the weight loss. Reduction of the stoma diameter is a good instrument for regulating the degree and speed of weight loss in patients with small pouches, but much less powerful in patients with large pouches.

Gastric banding for morbid obesity is theoretically an attractive method, since it is easily reversible, does not require opening of the stomach or intestines, and is associated with a very low surgical risk. The disadvantage is the high rate of reoperation because of the difficulty to obtain an optimal stoma diameter. This led us to develop a new gastric balloon band in which it is possible to regulate the inner diameter between 0 and 40 mm. In this study of the technical properties, we have investigated the inner pressure of the band during filling, the breaking point of the balloon when overfilling, the strength of the band and finally the degree of diffusion through the system. We found that there is no pressure with filling up to 10 ml. The band is thus a low pressure system. It can be filled with five times its normal volume before breaking. A pressure of 300 mmHg can be applied inside the system without breaking it. Finally, when the system was filled with soya oil, there was no detectable diffusion through the system in a one-year trial. These findings are consistent with our preset specifications. Clinical trials have therefore been started.