Obesity Surgery, 5, 61-64 Gastric Banding for Treatment Preliminary Results G. Bajardi; M. Florena G. Ricevuto; G. Mastrandrea; of Morbid G. Pischedda; Obesity: D. Valenti; G. Rubino; Departmenf of Surgical and Anatomical Sciences,Division of General and Vascular Surgery, University of Palermo, Palermo, Italy Background: gastric banding (GB) has been used for treatment of morbid obesity. Methods: a banding device, introduced by Broadbent and consisting of a self-blocking nylon strip covered with a silicone tube, was used in 13 patients who have completed l-year follow-up. This device was used for its mechanical properties, biocompatibility, ease of insertion and low cost. Results: at 1 year, mean excess weight loss was 51.6%, with all but one patient losing more than 25% of excess weight. Associated illnesses resolved. There were two complications (15%): one patient required band removal for selfinduced vomiting and one patient required repair of an incisional hernia. Conclusions: GB has had good results thus far. Reported differences depend on materials, stoma diameter, pouch size, and developing techniques. Key words: surgery Morbid obesity, gastric banding, bariatric Table 1. Clinical No. of patients Age Height (cm) Pre-op weight Pre-op excess Pre-op excess BMI Table data (kg) weight weight 2. Associated (kg) (%) 13 (10 female, 30 (19-55) 164 (155-179) 124.6 (lOl.rS148.5) 66 (44.8-92.4) 111.1 (77-168) 46 (38-57.5) 3 male) illnesses Hypertension Effort dyspnea Diabetes Hypercholesterolemia Hypertriglyceridemia Amenorrhea Mild renal insufficiency 2 2 2 3 1 1 1 (15%) (15%) (15%) (21%) (7%) (7%) (7%) Introduction Materials Morbid obesity is a major health problem in developed countries. Obesity increasesmorbidity and mortality, being a risk factor for metabolic and cardiovascular diseases.l As dietary restrictions have been unsuccessful in maintaining weight loss, bariatric surgery may be considered the only valid chance for these patients. Among various surgical techniques, gastric banding (GB) is the simplest method to reduce gastric volume and consequently food intake. We present our preliminary results on 13 patients whose follow-up is available at 12 months. During the period January-April 1993, 13 patients have been submitted to GB. Each patient was affected by morbid obesity in the absence of endocrine, gastro-oesophageal and psychiatric diseases;clinical data are shown in Table 1. Associated diseasesare reported in Table 2. Surgical access was gained through a median xipho-umbilical laparotomy; a self-blocking nylon string, inserted in a silicone. tube, was used as the banding material, according to Broadbent’s model.2 Gastric stoma calibration was achieved by tightening the band over a 12 mm diameter naso-gastric bougie previously positioned by the anesthesist.The proximal gastric pouch was calibrated by inflating with 30 cc of saline a balloon positioned at the distal Reprint requests to: Professor Villabianca 101, 90143 Palermo, 0 1995 Rapid Communications G. Bajardi, Via Marchese Italy; fax: 01139916552645 of Oxford di and Methods Ltd Obesity Surgery, 5, 1995 61 B~jmdi et al. Table 3. Weight loss after GB EW (kg) At surgery 1st p.o. month 6th p.o. month 12th p.o. month 63.3 53.3 40.6 31.1 EWL (%) 17.0 36.8 51.6 WL (kg) BMI 11.0 23.7 33.2 46.0 42.5 37.4 34.3 EW = excess weight; EWL = excess weight loss: loss; BMI = body mass index; p.o. = post-operative. Table 4. Weight loss - literature EWL = excess weight = weight results EWL Favretti et ZI/.‘~ Kuzmak” Forsell et a/.’ Lovig et a/.’ Lovig et al.7 Kirby et a1.9 WL 56 80 5.5 74 38 54 (%) Follow-up 12 10 12 12 60 12 months months months months months months follow-up. A functional gastric stoma stenosis at the seventh post-operative month caused band removal (7%); this patient used self-induced vomiting during the early post-operative period. After band removal, no other bariatric surgery attempt was made on this patient as weight loss achieved was judged satisfactory by herself, and she is being followed. We observed an incisional hernia (7%) at the fourth postoperative month, which was successfully repaired. No vitamin or other nutrient deficiency has been registered during the follow-up period. Hemoglobin, iron, electrolites and proteins were in normal range at the scheduled samples. The pre-operative elevated levels of cholesterol, triglycerides and blood sugar always corrected after surgery. In a patient who had longstanding amenorrhea pre-operatively, a normal ovulatory cycle restarted after the second post-operative month. loss Discussion end of the bougie, immediately below the cardia and proximal to the band. Antithrombotic prophylaxis was accomplished in each patient using intra and post-operative lower limbs elastic bandage, and early post-operative mobilization. On the third post-operative day a barium swallow was given to view gastric pouch emptying and gastric stoma patency. On the fourth post-operative day a low calory liquid diet was started (50 cc per day). From the seventh post-operative day until the sixth week, a semi-solid diet was advised, and patients were invited to self-regulate the amount of food intake according to the sensation of satiety. After the sixth post-operative week, a free diet was allowed. Results No early morbidity or mortality occurred. Each patient was seen at the first, third, sixth and 12th post-operative month. As shown on Table 3, the highest weight loss was achieved during the first 6 months; in this period mean weight loss was 23.7 kg, corresponding to 36.8% of pre-operative excess weight. During the second 6-month period, weight loss has been slower with tendency to stabilization. At the end of 1 year, mean weight loss was 32.2 kg, equal to 51.6% of mean pre-operative excess weight. In only one patient, weight loss (25% of pre-operative excess weight) was judged unsatisfactory. No major late complications were found during 62 Obesity surgery, 5, 199s Since its early proposal by Molina3 and K011,~ GB appeared to be a simple and safe technique, able to induce a sensible weight loss in morbidly obese patients. Minimal surgical trauma, as well as maintenance of gastro-enteric integrity, made this technique fully reversible. These characteristics led us to use GB as an alternative to biliopancreatic diversion (BPD), which we had performed since 1990.~ Our preliminary results show at 12 months an excess weight loss of 51.6%, with a residual obesity expressed by a mean BMI of 34.3; these findings are similar to those reported by others (Table 4). Unfortunately, these data are difficult to compare because of lack of standardization of some key steps in this technique such as gastric pouch and stoma calibration. Some authors have stressed the high percentage of complications and revisions.g,ll This may be due to variability in this technique regarding some markpoints like banding material, stoma diameter, gastric pouch volume, and whether the whole system will keep the configuration imposed by the surgeon during the implant. We had a late complication rate of 15%; for both of these patients surgery was necessary, to remove a band in one and repair an incisional hernia in the other. More serious complications, however, have been experienced by other workers. Among nonspecific reported complications, wound infections (5.7%) and incisional hernias (8.6-10%) are the commonest, followed by deep vein thrombosis (DVT) (1.7%) and p u 1monary complications (Table 5). Among specific complications, the most frequently Gastric Table 5. Non-specific Favretti Kuzmak Sjoberg Lovig et Table et a/.13 et a/.“’ et a1.6 al.7 6. Specific Favretti Kuzmak Sjoberg Lovig et Granstrom complications eta/.13 et aI.” et a/.6 a/.’ et al.” 4.6% 5.3% 17.0% 18.3% complications Early Late 3.4% 2.7% 5.4% 3.6% 4.1% 12.7% 10.6% 13.6% 25.9% 29.1% Re-operations 22.6% 9.2% 20.0% 14.9% 31.9% reported are stoma1 stenosis (with or without pouch dilatation), pouch perforation and band erosion into the gastric wall (Table 6); these complications determine a reintervention rate of lo-ZO%, with mortality almost absent.6,7Insufficient weight loss (7% in our experience) represents another reason for therapeutic failure. The optimal stoma diameter is considered to be 12 min;2,7,9KuzmaklO suggestsa wider stoma (13 mm) for patients below 146 kg. Smaller diameters (11 mm) have been reported as a cause of persistent vomiting in 2% of patients submitted to GB.” Granstrom,” using a Marlex mesh band, observed 16 stenoses(22%), occurring in patients whose stomas were calibrated with 11 or 12 mm bougies. The diameter of gastric stoma is not the only determinant of stenosis: stomas patent to a pediatric gastroscope have been observed in patients clinically showing persistent vomiting and excessive weight 10~s.~’Excessive food intake may lead to gastric pouch dilatation far beyond the intraoperatively determined measure, resulting in a stoma size insufficient for proper pouch emptying, and responsible for a ‘functional’ stenosis. Other complications, such as band kinking or erosion into the stomach wall, have been correlated with the materials employed. Marlex mesh, Dacron or PTFE have all been considered responsible for a fibrotic reaction by the surrounding tissuesor erosions of the gastric wall. ‘,I1 Pouch perforation with tissue materials, although rare (1.3%), is associated with a high morta1ity.r’ The major advantage of Broadbent’s system,’ beyond its very low cost, derives from the coupling of the nylon string stiffness and the silicone coveringtube biocompatibility. These characteristics seem to prove effective in preventing band dilatation, slippage or erosion into the gastric wall. Gastric pouch volume is the other important deter- Banding minant of success.Optimal volumes have variously been reported between 30 rnll’ and 50 m1;gin another seriesthe banding device has been passedbehind the stomach using anatomical landmarks for band position, like the short gastric vessels7’1’or the standard distance of 3 cm below the cardia.s Keeping correct pouch dimensions is very important, because pouch dilatation has been correlated with minimal weight loss and with weight gain observed after prolonged follow-up; 7,gfurthermore, a large gastric pouch can be considered responsible of a functional stenosis. We believe that pouch dimensioning is more precise using the inflated balloon technique. Full co-operation is required by the patient to achieve clinically satisfying results. The patient must be advised not to provoke vomiting, to take just enough food to reach satiety, and not to drink highcalorie beverages. Inability to cope with these simple recommendations must be considered a contraindication to this surgery, as results may be impaired and severe complications may ensue. Recently BroadbenP proposed laparoscopic positioning of his banding device. This appears to be a very important step in preventing morbidity related to the abdominal wall opening like incisional hernias, a complication constantly present in every bariatric surgery experience. Usually, GB does not result in syndromes related to vitamins, electrolytes and basic nutrients, but rare reports of these complications can be found in the literature.7 From this point of view, GB is much more reliable than other bariatric surgery techniques, like the BPD which we used in the past.5 However, we await longterm weight loss results. Beneficial effects in lowering cardiovascular risk factors have been observed. Conclusions GB is effective in weight loss in morbidly obese patients. Among the bariatric operations, it is the least invasive, is reversible and lacks GI tract opening. Laparoscopic positioning of the banding device will be a further strong reason to select this technique for surgical treatment of obesity. It is imperative that standardization of measuresand materials is achieved to compare different series in order to improve the results. Patient selection is a critical step, as most unsatisfactory results may be related to incapacity to follow dietary recommendations. Obesity Sqery, 5, 19% 63 et al. Bajardi References 1. Drenick EJ, Bale GS, Seltzer F, et al. Excessive mortality and causes of death in morbidly obese men. ]A&&4 1980; 243: 2. Broadbent Surg 443-S. R. A simple band for gastric banding. Obesity 1993;3:307-8. Molina M,. Oria HE. Gastric banding. Program 6th Bariatric Surgery Colloquium. Iowa City 1983, p. 15. 4. Kolle K. Gastric Banding, O.M.G.I. 7th Congress, Stockholm 1982, abstract 185, p. 37. 5. Bajardi G, Latteri AM, Ricevuto G, et al. Biliopancreatic diversion: early complications. Obesity Surg 1992; 2: 3. 177-80. 6. Sjoberg EJ, Andersen E, Hoe1 R, et al. Gastric banding in the treatment of morbid obesity. Acta Chir Stand 1989;155:31-4. 7. Lovig T, Hafner JFW, Kaaresen R, et al. Gastric banding for morbid obesity: 5 years follow-up. Int J Obes 1993; 17: 453-7. 64 Obesity 8. Forsell P, Hallberg D, Hellers G. Gastric banding for morbid obesity: initial experience with a new adjustable band. Obesity Surg 1993; 3: 369-74. 9. Kirby RM, Ismail T, Crowson M, et al. Gastric banding in the treatment of morbid obesity. Br ] Surg 1989; 76: surgery,s, 1995 490-L Kuzmak LI. Gastric banding. In: Deitel M, ed. Surgey for the Morbidly Obese Patient. Philadelphia: Lea and Febiger, 1989,225-60. 11. Granstrom L, Backman L. Technical complication and related reoperation after gastric banding. Acta Ckir Stand 1987;153:215-20. 12. Broadbent R, Tracey M, Harrington P. Laparoscopic gastric banding. A preliminary report. Obesity Surg 10. 1993; 3: 63-7. 13. Favretti F, Enzi G, Pizzirani E, et al. Adjustable silicone gastric banding (ASGB): the Italian experience. Obesity Surg 1993;3: 53-6. (Received 4 August 1994; accepted 15 November 19%).