EL-MINIA MED., BULL., VOL. 20, NO. 1, JAN., 2009 Hassanen et al EFFICACY OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING IN THE TREATMENT OF MORBID OBESITY By Ayman Hassanen, MD, Gamal Saleh, MD, Salah Abd EL-Raziq, MD Department of General Surgery - Minia University ABSTRACT: Aim: To determine the long-term efficacy and safety of laparoscopic adjustable gastric band (LAGB) in the treatment for morbid obesity and to detect whether age, gender, or preoperative body mass index (BMI) has an impact on the outcome. Patients and methods: All consecutive patients who had a LAGB inserted between October 2004 and October 2006 were evaluated prospectively at Department of General Surgery, Minia University Hospitals. Results: There were 32 females (78%) and 9 males (22%), with mean age 41.3±11, mean BMI 42.8±7.3 kg/m2. LAGB was successfully inserted in 39 of 41 included patients (95%). Mean operative time was 65± 30 minutes. The main complication was port leak in 4 patients (9.6%). The mean preoperative BMI was 42.8±7.3 versus 30±2.1 at 36 months postoperatively (Paired student “t” test, P<0.05). The mean preoperative weight was 118.3±22.9 versus 78±11.4 postoperatively (Paired student “t” test, P<0.05) There was no statistically significant difference in weight loss between different age groups up to 36 months after the band placement. Postoperative BMI at 36 months was 29.5±2.1 in age group (20-30y), 30±1.9 in age group (30-40y) and 30±3.9 in age group (40-50y), (One way ANOVA, P>0.05). The postoperative BMI was not affected by gender. Postoperative BMI at 36 months was 30±2.9 in males versus 29±2.9 in females (Student “t” test, P>0.05). The postoperative BMI was not affected by different preoperative BMI groups. At 36 months, postoperative BMI was 29.4±2.4 in BMI group (30-40), 30±1.6 in BMI group (40-50) and 31±3.9 in BMI group (5060) (One way ANOVA, P>0.05). Conclusion: The LAGB is effective in achieving long-term sustainable weight loss with an acceptably low complication rate. Bands are effective regardless of patient’s age, gender and BMI. KEY WORDS: Laparoscopy Morbid obesity Bariatric surgery lung dysfunction, and psychological disease3. Bariatric surgery is the only evidence-based approach to achieving sustainable weight loss in morbidly obese adults4. The laparoscopic adjustable gastric band (LAGB) is the most commonly used bariatric procedure. Alarmingly, obesity often starts in childhood5. The Swedish adjustable gastric band (SAGB) was introduced in Sweden in 19856 and it has been INTRODUCTION: Obesity is a growing public health concern in the world. According to a recent study by the Research and Development (RAND) organization, obesity is more damaging to health than smoking, high levels of alcohol consumption, or poverty1-2. This is due to its multiple co-morbid diseases, including diabetes, cardiovascular disease, musculoskeletal disorders, 49 EL-MINIA MED., BULL., VOL. 20, NO. 1, JAN., 2009 estimated that more than 120,000 gastric bands have been placed worldwide. There are numerous studies presenting their short-term efficacy7,8. However, despite a large experience in different centers, few publications have reported long-term efficacy of the LAGB9–10. Additionally, there is controversy in the literature as regard the impact of age, sex, and initial BMI at 3 years after LAGB. Our study reports the results in a series of 41 patients as regards of their preoperative age, gender, and BMI at long-term follow-up (3 years). Hassanen et al potential risks, and complications at operation and in the postoperative period. A written informed consent was taken from all patients. Preoperative investigations performed included gastroscopy, base-line hematological and biochemical investigations and abdominal ultrasound to document the presence of gallstones. The operation was done under general anesthesia. The patient was placed in the lithotomy position with reverse Trendelenburg to approximately 40○. The pneumoperitoneum was initiated and 6 ports were placed. We used the open visual access with a 10 mm Optiview trocar with a 0 telescope to allow access then it was replaced by telescope 30○. The Optiview trocar was placed laterally just below the left costal margin. The abdomen was insufflated to 15 mm Hg and additional ports were placed under direct vision including two 5 mm right sub costal ports, a 5 mm upper midline port, 18 mm left upper quadrant paramedian port and a 5 mm left upper quadrant port. The pars flacida in the hepatogastric ligament was incised (Fig 1, 2) close to the esophago-gastric junction. Then the right crus was visualized (Fig 3) after incision of the covering peritoneum. After minimal blunt and sharp dissection of the angle of Hiss to visualize the left crus (Fig 4), the retro-gastric tunnel was created below the esophago-gastric junction with the help of golden finger (Ethicon Endo Surgery) and the band (SAGB, Ethicon Endo Surgery) or (Lap-band, Allergan) was pulled behind the stomach after being introduced into the abdomen via the 18 mm trocar. After closing the band (Fig 5), a proximal gastric pouch of about 10 to 15 ml was created and secured with three to four non-absorbable gastro-gastric sutures (Fig 6) to avoid band slippage and pouch dilatation. After pulling out the tube, the pneumoperitoneum was PATIENTS AND METHODS: All morbidly obese patients who had a LAGB placed at General surgery Department of Minia University Hospitals from October 2004 to October 2006 were included, and their data recorded prospectively. The placement of LAGB was undertaken in patients who were referred for bariatric surgery. The indications for bariatric surgery were based on a number of parameters that included BMI, previous significant attempts to lose weight by dietary means, and the presence of significant co-morbidities. BMI criteria were those defined by National Health and Medical Research Council11 (BMI more than 40 or 35 with 1 or more co-morbidities). In addition, patients between BMI 30 and 35 were included if co-morbidities such as diabetes and sleep apnea were difficult to manage without weight reduction and could not be achieved by nonsurgical means. Exclusion criteria included inability to understand necessary intensive follow-up and operative procedures, untreated psychiatric disorders. All patients received multidisciplinary (medical, nutritional, psychological, and surgical) screening and education before surgery. Patients were informed about dietary requirements, follow-up protocol, 50 EL-MINIA MED., BULL., VOL. 20, NO. 1, JAN., 2009 released and the tube was connected to the port anterior to the rectus sheath. Hassanen et al for two independent samples and a paired t-test for paired observations except where otherwise noted. Data were analyzed using SPSS 10 for windows and One-Way ANOVA. P value of less than 0.05 was considered to indicate statistical significance. After starting fluid intake on the first postoperative day, a gastrograffin swallow was performed on the second postoperative day and the patient was discharged on the third postoperative day. Patients were seen by one of the treating physicians for band adjustments at 6 weeks and then every 3 months or as needed throughout the year and weighed at each visit. Most adjustments were performed by direct palpation. RESULTS: Between October 2004 and October 2006, 41 patients who underwent placement of LAGB at Department of General Surgery, Minia University Hospitals were prospectively evaluated. Early postoperative complications were those occurring within 30 days of the operation. Demographics: There were 32 females (78%) and 9 males (22%), with the mean preoperative age of 41.3±11 years. Twelve patients (29.2%) had previous cholecystectomy and 9 patients (21.9%) had a history of previous pelvic operations. Patient demographics were shown in Table 1. Long-term complications were those occurring after 30 days of the operation. Patients were considered to be lost to follow-up if they had not been reviewed in the previous 6 months. Operation: In this series, successful laparoscopic gastric banding was done in 39 of 41 included patients (95%) Mean operative time was 65± 30 minutes; it was 115±35 min for the first 20 patients and 55±25 min for the second 21 patients. Conversion to laparotomy was necessary in 2 patients (4.8%). These conversions took place early in the first year of the start of the study. Conversions were required in two patients (4.8%) due to adhesions from previous surgery and enlarged left lobe of the liver with difficulty in its retraction. There was no blood transfusion required in any patient. An additional operation was performed in 10(24.3%) of the patients; 6 (14.6%) hiatus hernia repair was performed by the approximation of the crura, at the time of band placement; 4 patients (9.7%) with known gallstones before surgery underwent simultaneous lapa- Efficacy of the surgery was determined by measure-ment of change in the percentage excess weight loss (%EWL), BMI, and absolute weight change in kilograms over the follow-up period. The classification developed by Reinhold12 was used to define the outcome. Success was defined as EWL more than 50%, whereas failure was defined as EWL less than 50%. The effect of preoperative BMI, age, and gender on outcome was evaluated. STATISTICAL METHODS: Descriptive data were expressed as mean + standard deviation or medians and ranges for continuous variables and as number and percent for categorical variables. Comparisons of discrete variables were analyzed with Fishers exact test, and comparisons of continuous variables were analyzed with a two-sample t-test 51 EL-MINIA MED., BULL., VOL. 20, NO. 1, JAN., 2009 Hassanen et al roscopic cholecystectomy during the gastric banding procedure. was no deep venous thrombosis, pulmonary embolism. Operative Morbidity: Operative complications occurred in 2 patients (4.8%). Accidental laceration of the left hepatic lobe occurred in 1 patient (2.4%), which spontaneously resolved. In addition, there was one patient with bleeding around the spleen (2.4%), which stopped on application of local pressure. Weight loss: The mean preoperative BMI was 42.8±7.3 versus 30±2.1 at 36 months postoperatively (P<0.05, Paired student “t” test). The mean preoperative weight was 118.3±22.9 versus 78±11.4 postoperatively (P<0.05, Paired student “t” test). The postoperative BMI was not affected by different age groups. There was no statistically significant differrence in weight loss between different age groups up to 36 months after the band placement. Postoperative BMI at 36 months was 29.5±2.1 in age group (20-30y), 30±1.9 in age group (30-40y) and 30±3.9 in age group (40-50y) (P>0.05, One way ANOVA). Early postoperative Morbidity: Early complications occurred within the first month after surgery. These included wound infection in 2 patients (4.8%), port infection in 2 patients (4.8%), Table 2. Wound infections responded to postoperative oral antibiotics for 1 week. In patients with port site infection, the port was removed, and patients treated with antibiotic and local antiseptic until the infection cleared and the wound healed. The injection port was reinserted after 3 months. The postoperative BMI was not affected by gender. Postoperative BMI at 36 months was 30±2.9 in males versus 29±2.9 in females (P>0.05, Student “t” test). The postoperative BMI was not affected by different preoperative BMI groups. Postoperative BMI at 36 months was 29.4±2.4 in BMI group (35-40), 30±1.6 in BMI group (40-50) and 31±3.9 in BMI group (50-60) (P>0.05, One way ANOVA). Late postoperative Morbidity: Late complication included one anterior slipped band (2.4%). The band was repositioned via laparoscopy, and the patient has remained well. There were one (2.4%) band erosion and 4 port or catheter leaks (9.7%), Table 2. Band erosion within the stomach clinically presented with loss of restriction from the band. Erosion was diagnosed endoscopically (Fig 7) and treated by removal of the band laparoscopically. Two patients developed gallstones (4.8%). There Using the Reinhold12 classification to distinguish excellent and poor weight loss, more than 70% of the patients lost more than 50% of their excess weight after 3 years of surgery. 52 EL-MINIA MED., BULL., VOL. 20, NO. 1, JAN., 2009 Hassanen et al Table 1: Patients demographics Character Number Mean age±SD (years) Mean weight±SD (Kg) Mean height±SD (cm) Mean BMI±SD (Kg/m2) Mean excess weight±SD (Kg) Age groups: 20-30 years 30-40 years 40-50 years Preoperative BMI groups: 30-40 40-50 50-60 History of cholecystectomy History of pelvic operation Value 41 (32/9) 41.3±11 118.3±22.9 168±21.2 42.8±7.3 55.2±20.7 9 (22%) 22 (54%) 10 (24%) 15 (36%) 20 (49%) 6 (15%) 12 (29.2%) 9 (12.9%) Table 2: Complication Complication Wound infection Port infection Port leak Band slippage Band erosion Gall stone formation Number (%) 2 (4.8) 2 (4.8) 4 (9.6) 1 (2.4) 1 (2.4) 2 (4.8) 53 EL-MINIA MED., BULL., VOL. 20, NO. 1, JAN., 2009 Hassanen et al Fig 1: Incision of the pars flacida in the hepatogastric ligament. Fig 2: The pars flacida after openining Fig 3: Incision of the peritoneum over the right crus 54 EL-MINIA MED., BULL., VOL. 20, NO. 1, JAN., 2009 Fig 4: Incision of the peritoneum over the left crus Fig 5: The band after its closure Fig 6: The band was secured by gastro-gastric sutures 55 Hassanen et al EL-MINIA MED., BULL., VOL. 20, NO. 1, JAN., 2009 Hassanen et al Fig 7: Endoscopic diagnosis of band erosion as rapid as seen after operations such as gastric bypass where up to 70% of excess weight is lost.17 However, with the passage of time the weight loss and sustainability of %EWL with gastric bypass decreases and by 3 years and beyond it approaches the 60% value.18 This result at 3 years is similar to that reported in our study and suggests that in terms of efficacy over a prolonged period there may be little difference between treatments via SAGB versus gastric bypass. Prospective randomized studies may answer this question, but other parameters as safety, cost effectiveness, availability of procedures, and patient acceptability may determine what is offered to specific patients. DISCUSSION: The physiologic improvements that result from even modest weight loss have been well documented. The 10% of excess weight loss has been shown to improve obstructive sleep apnea, cardiovascular risk, inflammation, thromboembolic risk, and serum glucose concentration. In addition to improving physiologic parameters, modest weight loss may even reduce intraabdominal adiposity with reduction of both intraabdominal and intrahepatic fat.13 Effective long-term weight reduction can be achieved in obese patients following insertion of a soft adjustable gastric band such as the SAGB. On long-term follow-up more than 70% of patients had a sustainable weight loss of greater than 50% of their excess weight. These results are similar to other series using the adjustable gastric band.14,15 In addition, it illustrates that the effectiveness that had previously been demonstrated,16 is sustained up to 3 years. Weight loss with the SAGB in the first year is not The relative safety of bariatric surgery using the adjustable gastric band is illustrated by the results of this study. Band slippage was a major complication after use of perigastric approache19. After the operative technique was changed from perigastric to pars flaccida placement of the band, this complication has become 56 EL-MINIA MED., BULL., VOL. 20, NO. 1, JAN., 2009 uncommon20. The results of this study are similar to patients with pars flacida approach20. Hassanen et al no effect on long-term efficacy for weight loss. This is contrary to a Branson et al study27 that demonstrated a similar overall weight reduction but showed that the procedure was more effective in younger women when compared with older men. Hence, age and gender do not seem to be a major discriminator for success. Initial BMI also has been thought to select patients for the different procedures. In this study, there was no difference demonstrated in efficacy in patients with different BMI. The relatively slow rate of weight loss produced by the SAGB may account for the low prevalence of postoperative gallstone formation. In patients having gastric bypass symptomatic gallstones were reported in up to 14% of patients28. In this series only 4.8% developed gallstones. It has previously shown that the rate of weight reduction affects gallbladder motility and a weight reduction rate in excess of 1 kg per week is associated with reduced gallbladder emptying.29 Changes in the co-morbidities of obesity have not been evaluated for this series of patients. A number of other series have demonstrated the therapeutic impact of weight reduction on the co-morbidities of diabetes30, hypertension30, sleep apnea31, and the metabolic syndrome.32 Furthermore, patients who lose weight in excess of 25% of excess weight generally have positive quality of life scores.33 Conclusion: The gastric banding is effective in achieving long-term sustainable weight loss with an acceptably low complication rate. Bands are effective regardless of patients’ age, gender, and BMI Erosion of the band into the stomach remains a major complication affecting 2.4% of the patients. This complication has been treated by the removal of the band via the endoscopic or laparoscopic approach, which subsequently permits either reinsertion of an adjustable gastric band or another bariatric procedure.21 The cause of band erosion is unknown.21 However, it is associated with excessive fluid in the band, which may produce ischemia of the underlying stomach.22 Alternatively, erosion may start as an ulcer of the mucosa and this may erode towards the band.23 In other series there is a suggestion that it may be associated with infection of the port, the connecting tubing, or the band itself.24 A clear relationship of causes has not been demonstrated in our study, and no single factor has been identified to cause band erosion. Reservoir port site infection was another common complication.24 This complication occurred within the 30 days of the postoperative period. Control of the infection occurred only after removal of the infection port. In these instances the port was reinserted 3 months after removal and when the infection had resolved. Operative mortality associated with the insertion of an adjustable gastric band is low and significantly lower to that reported for other bariatric operations25. This result makes this operation attractive to patients, even though the initial weight reduction may not be as rapid as that experienced by the more invasive procedures such as gastric bypass. Patient demographics and initial BMI has been suggested as a mean to select patients for the different bariatric procedures.26 In this study, gender had REFERENCES 1. Sturm R. The effects of obesity, smoking, and problem drinking on chronic medical problems and health care costs. Health Affairs 2002; 21: 245-53. 57 EL-MINIA MED., BULL., VOL. 20, NO. 1, JAN., 2009 2. Sturm R, Wells KB. Does obesity contribute as much to morbidity as poverty or smoking? Public Health 2001; 115: 229-35. 3. 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Surg Laparosc Endosc Percutan Tech. 2006; 16:131–136 59 Hassanen et al EL-MINIA MED., BULL., VOL. 20, NO. 1, JAN., 2009 تأثير تركيب حزام المعدة بالمنظار الجراحي في عالج السمنة المفرطة أيمن حسانين -جمال صالح -صالح عبد الرازق قسم الجراحة العامة بكلية طب المنيا إن الهدف من هذه الدراسه هو تقييم الدور طويل المدي لتركيب حزام المعده في عالج السمنة المفرطة وكذلك لتحديد اذا كان هناك تأثير لعامل العمر والجنس ومعدل السمنة على نتائج العملية .وتم اجراء هذه الدراسه فى قسم الجراحة العامة بمستشفى المنيا الجامعى فى الفترة من أكتوبر 2004الى أكتوبر 2006وكانت النتائج كما يلى: بلغ عدد المرضى 32مريضة ( )%78وعدد 9مرضى رجال ( )%22وقد تم تركيب حزام المعده بالمنظار الجراحي بنجاح فى عدد 39من عدد 41مريضا ( )%95وكان متوسط وقت العمليه 65دقيقة وحدث تسريب في مكان الصمام في عدد 4مرضى ( )%9.6وكان معدل السمنة قبل العملية 42.8 ±7.3مقارنة بالرقم 30 ±2.1بعد 36شهرا بعد العملية حيث كان ذلك ذو داللة إحصائية .وكان متوسط الوزن قبل العملية 118 ±22.9كيلوجرام مقارنة بالرقم 78±11.4بعد 36شهرا من العملية حيث كان ذلك ذو داللة إحصائية. وبالمتابعه التى امتدت 36شهرا حيث لم يكن هناك فارق في معدل السمنة بتغير عامل العمر اوالجنس اومعدل سمنة ما قبل العملية. وقد تم استنتاج ان تركيب حزام المعدة بالمنظار الجراحي في عالج السمنة المفرطة يعتبر طريقه ناجحه النقاص الوزن لمدى طويل وبنسبة مضاعفات قليلة ونتائجها ال تتغير ببتغير عامل العمر او الجنس او معدل سمنة ما قبل العملية . 60