Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24 Months.

BACKGROUND: Weight regain following bariatric surgery is not uncommon. Safe, effective weight loss treatment up to 1 year has been reported with the closed-loop gastric electrical stimulation (CLGES) system. Continuous recording of eating and activity behavior by onboard sensors is one of the novel features of this closed-loop electrical stimulation therapy, and may provide improved long-term weight maintenance by enhancing aftercare. METHODS: Four centers participating in a 12-month prospective multicenter randomized study monitored all implanted participants (n = 47) up to 24 months after laparoscopic implantation of a CLGES system. Weight loss, safety, quality of life (QOL), and cardiac risk factors were analyzed. RESULTS: Weight regain was limited in the 35 (74%) participants remaining enrolled at 24 months. Mean percent total body weight loss (%TBWL) changed by only 1.5% between 12 and 24 months, reported at 14.8% (95% CI 12.3 to 17.3) and 13.3% (95% CI 10.7 to 15.8), respectively. The only serious device-/procedure-related adverse events were two elective system replacements due to lead failure in the first 12 months, while improvements in QOL and cardiovascular risk factors were stable thru 24 months. CONCLUSION: During the 24 month follow-up, CLGES was shown to limit weight regain with strong safety outcomes, including no serious adverse events in the second year. We hypothesize that CLGES and objective sensor-based behavior data combined to produce behavior change. The study supports CLGES as a safe obesity treatment with potential for long-term health benefits. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01448785.

Closed-loop gastric electrical stimulation versus laparoscopic adjustable gastric band for the treatment of obesity: a randomized 12-month multicenter study.

OBJECTIVE: To compare the weight loss, change in quality of life (QOL) and safety of closed-loop gastric electrical stimulation (CLGES) versus adjustable gastric band (LAGB) in the treatment of obesity. METHODS: This multicenter, randomized, non-inferiority trial randomly assigned the patients in a 2:1 ratio to laparoscopic CLGES versus LAGB and followed them for 1 year. We enrolled 210 patients, of whom 50 were withdrawn preoperatively. Among 160 remaining patients (mean age=39±11 years; 75% women; mean body mass index=43±6 kg m-2) 106 received CLGES and 54 received LAGB. The first primary end point was non-inferiority of CLGES versus LAGB, ascertained by the proportion of patients who, at 1 year, fulfilled: (a) a ⩾20% excess weight loss (EWL); (b) no major device- or procedure-related adverse event (AE); and (c) no major, adverse change in QOL. Furthermore, ⩾50% of patients had to reach ⩾25% EWL. The incidence and seriousness of all AE were analyzed and compared using Mann-Whitney's U-test. RESULTS: At 1 year, the proportions of patients who reached all components of the primary study end point were 66.7 and 73.0% for the LAGB and CLGES group, respectively, with a difference of -6.3% and an upper 95% CI of 7.2%, less than the predetermined 10% margin for confirming the non-inferiority of CLGES. The second primary end point was also met, as 61.3% of patients in the CLGES group reached ⩾25% EWL (lower 95% CI=52.0%; P<0.01). QOL improved significantly and similarly in both groups. AE were significantly fewer and less severe in the CLGES than in the LAGB group (P<0.001). CONCLUSIONS AND RELEVANCE: This randomized study confirmed the non-inferiority of CLGES compared with LAGB based on the predetermined composite end point. CLGES was associated with significantly fewer major AE.

Diabetes surgery in type 2 BMI 24-29 vs IMC 30-34 diabetic patients: is there differences among restrictive, malabsorptive and gastric bypass procedures?

Diabetes mellitus (DM) is a public health problem with a prevalence of 345 million people worldwide that it may double by the year 2030 and have a high costs and mortality. Gastrointestinal surgery is accepted as a form of treatment that was already suggested for obese in 1987 by Pories, confirmed for obese patients by the metaanalysis of Buchwald and the direct comparison of gastric bypass with medical treatment in the study of Schauer that demonstrate a 4 fold greater resolution rate of DM with surgery. Improvement occurs immediately after surgery, before the patients lose weight in with BMI > 35; but there is doubt if the existent evidence is enough to extrapolate these results to patients with BMI < 35 and especially with BMI < 30, in spite that four reviews in patients with this BMI and DM2 demonstrated the same results when stomach, duodenum and part of jejunum is bypassed as happen gastric bypass (better results with this of one anastomosis than of two anastomosis, Roux-en-Y) BPD. For patients with a BMI between 30 and 35 restrictive techniques: LAGB and SGL are good but not better than the mixed: RYGB, BAGUA, or SG-DJB with remission from 60 to 100%, minor in the derivative: BPD and above on the IID with a 81% of remission. There are no differences in the metabolic control in comparison to the obese, It is progressively better with DJB, SDS, IID and BAGUA especially in patients who do not require insulin, have less time with disease, have normal C peptide levels, and not so much relation with the initial BMI that is only important to decide the degree of restriction. Although several mechanisms has been suggested for explaining these results such as caloric intake, hormonal changes, bypass of the anterior or early stimulation of posterior intestine, fundectomy, intestinal gluconeogenesis and others, new ones will appear in the near future.

La diabetes mellitus (DM) es un problema de salud pública, con una prevalencia de 345 millones de personas, que puede duplicarse para el año 2030 y con importante repercusión en costes y mortalidad. La cirugía gastrointestinal es aceptada como una forma de tratamiento sugerida en obesos desde 1987 por Pories, y confirmada por el meta-análisis de Buchwald y la comparación directa del bypass gástrico con el mejor tratamiento médico en el estudio de Schauer que pone de manifiesto un índice de remisión 4 veces mayor con la cirugía. La mejoría ocurre inmediatamente después de la cirugía, antes de la pérdida de peso en pacientes con IMC > 35; pero hay duda si la evidencia existente es suficiente para extrapolar estos resultados a pacientes con IMC < 35 y especialmente con IMC < 30, a pesar de existir cuatro revisiones en pacientes con este IMC y DM2 que demuestran los mismos resultados que en obesos cuando se puentea estómago, duodeno y parte del yeyuno como pasa en el bypass gástrico y la DBP. Para pacientes con IMC entre 30 y 35 las técnicas restrictivas: BGAL Y GVL son buenas pero no superiores a las mixtas: BGYR, BAGUA o GV-BDY con remisión desde 60 a 100%, menor en las derivativas: DBP y mayor en la IID con un 81% de remisión. En pacientes con sobrepeso no existen diferencias en el control metabólico respecto a los obesos. Es progresivamente mejor con DBP, CDC, IID y BAGUA sobre todo en pacientes que no requieren insulina, tienen menos tiempo con la enfermedad o con un nivel de peptido C normal, factores determinantes y no así el IMC inicial que sólo influye en el volumen de restricción. Aunque se han sugerido distintos mecanismos para explicar los resultados como ingesta calórica, hormonales, teoría del intestino anterior o posterior, fundectomía , neoglucogénesis intestinal y otros, aparecerán más en un futuro no lejano.

Diabetes surgery in type 2 BMI 24-29 vs IMC 30-34 diabetic patients: is there differences among restrictive, malabsorptive and gastric bypass procedures? / Cirugía en pacientes con diabetes tipo 2 IMC 24-29 vs IMC 30-34: ¿existen diferencias entre los procedimientos restrictivos, malabsortivos y bypass gástrico?

Diabetes mellitus (DM) is a public health problem with a prevalence of 345 million people worldwide that it may double by the year 2030 and have a high costs and mortality. Gastrointestinal surgery is accepted as a form of treatment that was already suggested for obese in 1987 by Pories, confirmed for obese patients by the meta-analysis of Buchwald and the direct comparison of gastric bypass with medical treatment in the study of Schauer that demonstrate a 4 fold greater resolution rate of DM with surgery. Improvement occurs immediately after surgery, before the patients lose weight in with BMI > 35; but there is doubt if the existent evidence is enough to extrapolate these results to patients with BMI < 35 and especially with BMI < 30, in spite that four reviews in patients with this BMI and DM2 demonstrated the same results when stomach, duodenum and part of jejunum is bypassed as happen gastric bypass (better results with this of one anastomosis than of two anastomosis, Rouxen-Y) BPD. For patients with a BMI between 30 and 35 restrictive techniques: LAGB and SGL are good but not better than the mixed: RYGB, BAGUA, or SG-DJB with remission from 60 to 100%, minor in the derivative: BPD and above on the IID with a 81% of remission. There are no differences in the metabolic control in comparison to the obese, It is progressively better with DJB, SDS, IID and BAGUA especially in patients who do not require insulin, have less time with disease, have normal C peptide levels, and not so much relation with the initial BMI that is only important to decide the degree of restriction. Although several mechanisms has been suggesed for explaining these results such as caloric intake, hormonal changes, bypass of the anterior or early stimulation of posterior intestine, fundectomy, intestinal gluconeogenesis and others, new ones will appear in the near future (AU)

La diabetes mellitus (DM) es un problema de salud pública, con una prevalencia de 345 millones de personas, que puede duplicarse para el año 2030 y con importante repercusión en costes y mortalidad. La cirugía gastrointestinal es aceptada como una forma de tratamiento sugerida en obesos desde 1987 por Pories, y confirmada por el meta-análisis de Buchwald y la comparación directa del bypass gástrico con el mejor tratamiento médico en el estudio de Schauer que pone de manifiesto un índice de remisión 4 veces mayor con la cirugía. La mejoría ocurre inmediatamente después de la cirugía, antes de la pérdida de peso en pacientes con IMC > 35; pero hay duda si la evidencia existente es suficiente para extrapolar estos resultados a pacientes con IMC < 35 y especialmente con IMC < 30, a pesar de existir cuatro revisiones en pacientes con este IMC y DM2 que demuestran los mismos resultados que en obesos cuando se puentea estómago, duodeno y parte del yeyuno como pasa en el bypass gástrico y la DBP. Para pacientes con IMC entre 30 y 35 las técnicas restrictivas: BGAL Y GVL son buenas pero no superiores a las mixtas: BGYR, BAGUA o GV-BDY con remisión desde 60 a 100%, menor en las derivativas: DBP y mayor en la IID con un 81% de remisión. En pacientes con sobrepeso no existen diferencias en el control metabólico respecto a los obesos. Es progresivamente mejor con DBP, CDC, IID y BAGUA sobre todo en pacientes que no requieren insulina, tienen menos tiempo con la enfermedad o con un nivel de peptido C normal, factores determinantes y no así el IMC inicial que sólo influye en el volumen de restricción. Aunque se han sugerido distintos mecanismos para explicar los resultados como ingesta calórica, hormonales, teoría del intestino anterior o posterior, fundectomía , neoglucogénesis intestinal y otros, aparecerán más en un futuro no lejano (AU)

A review of unmet needs in obesity management.

The prevalence of obesity continues to escalate in the USA; however, there is no consensus regarding the optimal therapy for obesity. For the vast majority of severely obese patients, conventional medical therapies (i.e., diet, exercise, behavioral counseling) often fail over the long term. Existing pharmacotherapy adjunctive to behavioral therapy has limited effectiveness and an imperfect safety record. In contrast, bariatric surgery has a high degree of weight loss efficacy, yet only a small fraction of the qualifying obese population undergoes these procedures because of the associated perioperative risks and potential late complications. In addition, the role of bariatric surgery is unclear in certain patient populations, such as patients with lower body mass index (BMI, 30-35 kg/m(2)), the high-risk super-super obese patients (BMI > 60), the morbidly obese adolescent, and obese patients requiring weight reduction in preparation for other procedures, such as orthopedic, transplant, or vascular surgeries. In these circumstances, there is a need for an effective but less invasive treatment to bridge the gap between medical and surgical therapy. This review examines current treatment outcomes, identifies prominent areas of unmet clinical needs, and provides an overview of two minimally invasive "temporary procedures for weight loss" that may eventually address some of the unmet needs in obesity management.

Obese teenagers treated by Lap-Band System: the Italian experience.

BACKGROUND: Little is known about obesity surgery in young and adolescent patients. The aim of this study is to evaluate results of laparoscopic adjustable gastric banding in obese teenagers. METHODS: Patients < or = 19 years old selected from the database of the Italian Collaborative Study Group for Lap-Band were analyzed according to mortality, comorbidities, laparotomic conversion, intra- and postoperative complications, body mass index (BMI), and % excess weight loss (EWL) at different times of follow-up. Data were expressed as mean +/- SD. RESULTS: Fifty-eight (1.5%) of 3813 patients who underwent operation with the Lap-Band System were < or = 19 years old: 47F/11M; mean age, 17.96 +/- 0.99 years (range, 15-19); mean BMI, 46.1 +/- 6.31 Kg/m2 (range, 34.9 - 69.25); mean % excess weight, 86.4 +/- 27.1 (range, 34 - 226.53). Sixteen (27.5%) of the 58 patients were superobese (BMI > or = 50). In 27/58 (46.5%) patients, 1 or more comorbidities were diagnosed. Mortality was absent. Laparotomic conversion was necessary in 1 patient with gastric perforation on the anterior wall. Overall postoperative complications occurred in 6/58 (10.3%). The band was removed in 6/58 (10.3%) patients for gastric erosion (3 patients), psychologic, intolerance (2 patients), and in the remaining patient was converted 2 years after surgery (BMI 31) to gastric bypass or gastric pouch dilatation. Patient follow-up at 1, 3, 5, and 7 years was 48/52 (92.3%), 37/42 (88.1%), 25/33 (75.7%), and 10/10, respectively. At these times, mean BMI was 35.9 +/- 8.4, 37.8 +/- 11.27, 34.9 +/- 12.2, and 29.7 +/- 5.2 Kg/m2. Mean %EWL at the same time was 45.6 +/- 29.6, 39.7 +/- 29.8, 43.7 +/- 38.1, and 55.6 +/- 29.2. Five/25 (20%) patients had < or = 25% EWL at 5 years follow-up, while none of the 10 patients subject to follow-up at 7 years had < or = 25% EWL. CONCLUSIONS: Lap-Band System is an interesting option for teenagers suffering obesity and its related comorbidities, which deserves further investigation.

Obesity surgery: evidence-based guidelines of the European Association for Endoscopic Surgery (EAES).

BACKGROUND: The increasing prevalence of morbid obesity together with the development of laparoscopic approaches has led to a steep rise in the number of bariatric operations. These guidelines intend to define the comparative effectiveness and surrounding circumstances of the various types of obesity surgery. METHODS: A consensus panel representing the fields of general/endoscopic surgery, nutrition and epidemiology convened to agree on specific questions in obesity surgery. Databases were systematically searched for clinical trial results in order to produce evidence-based recommendations. Following two days of discussion by the experts and a plenary discussion, the final statements were issued. RECOMMENDATIONS: After the patient's multidisciplinary evaluation, obesity surgery should be considered in adults with a documented BMI greater than or equal to 35 and related comorbidity, or a BMI of at least 40. In addition to standard laboratory testing, chest radiography, electrocardiography, spirometry, and abdominal ultrasonography, the preoperative evaluation of obesity surgery patients also includes upper gastrointestinal endoscopy or radiologic evaluation with a barium meal. Psychiatric consultation and polysomnography can safely be restricted to patients with clinical symptoms on preoperative screening. Adjustable gastric banding (GB), vertical banded gastroplasty (VBG), Roux-en-Y gastric bypass (RYGB) and biliopancreatic diversion (BPD) are all effective in the treatment of morbid obesity, but differ in degree of weight loss and range of complications. The choice of procedure therefore should be tailored to the individual situation. There is evidence that a laparoscopic approach is advantageous for LAGB, VBG, and GB (and probably also for BPD). Antibiotic and antithromboembolic prophylaxis should be used routinely. Patients should be seen 3 to 8 times during the first postoperative year, 1 to 4 times during the second year and once or twice a year thereafter. Outcome assessment after surgery should include weight loss and maintainance, nutritional status, comorbidities and quality-of-life.

Italian Group for Lap-Band System: results of multicenter study on patients with BMI < or =35 kg/m2.

BACKGROUND: The Lap-Band System is the most common bariatric operation world-wide. Current selection criteria do not include patients with BMI < or = 35. We report the Italian multicentre experience with BMI < or = 35 kg/m(2) over the last 5 years. PATIENTS AND METHODS: Data were obtained from 27 centres involved in the Italian Collaborative Study Group for Lap-Band System. Detailed information was collected on a specially created electronic data sheet (MS Access 2000) on patients operated in Italy since January 1996. Items regarding patients with BMI < or = 35 were selected. Data were expressed as mean +/- SD except as otherwise indicated. RESULTS: 225 (6.8%) out of 3,319 Lap-Band patients were recruited from the data-base. 15 patients, previously submitted to another bariatric procedure (BIB =14; VBG= 1) were excluded. 210 patients were eligible for study (34M/176F, mean age 38.19+/-11.8, range 17-66 years, mean BMI 33.9+/-1.1, range 25.1-35 kg/m(2), mean excess weight 29.5+/-7.1, range 8-41). 199 comorbidities were diagnosed preoperatively in 55/210 patients (26.2%). 1 patient (0.4%) (35 F) died 20 months postoperatively from sepsis following perforation of dilated gastric pouch. There were no conversions to laparotomy. Postoperative complications presented in 17/210 patients (8.1%). Follow-up was obtained at 6, 12, 24, 36, 48 and 60 months. At these time periods, mean BMI was 31.1+/-2.15, 29.7+/-2.19, 28.7+/-3.8, 26.7+/-4.3, 27.9+/-3.2, and 28.2+/-0.9 kg/m(2) respectively. Co-morbidities completely resolved 1 year postoperatively in 49/55 patients (89.1%). At 60 months follow-up, only 1 patient (0.4%) has a BMI >30. CONCLUSIONS: Although surgical indications for BMI < or = 35 remain questionable, the Lap-Band in this study demonstrated that all but 1 patient achieved normal weight, and most lost their co-morbidities with a very low mortality rate.

The Italian Group for LAP-BAND: predictive value of initial body mass index for weight loss after 5 years of follow-up.

BACKGROUND: Laparoscopic of the LAP-BAND System placement stage of obesity is a safe operation, but its indication in terms of stage of obesity is controversial. The aim of this study was to evaluate the 5 years stage of obesity results for weight loss in patients with varying preoperative ranges of body mass index (BMI). METHODS: Data were obtained from the Italian Collaborative Study Group for LAP-BAND System (GILB) registry. Detailed information was collected on a specifically created database (MS Access 2000) for patients operated on in Italy from January 1996 to 2003. Patients operated on between January 1996 and December 1997 were allocated to four groups according to preoperative BMI range: 30-39.9 kg/m(2) (group A), 40-49.9 kg/m(2) (group B), 50-59.9 kg/m(2) (group C), and =60 kg/m(2) (group D) percent estimated weight loss respectively. Postoperative complications, mortality, BMI, BMI loss, and (%EWL) were considered in each group. Data are expressed as mean +/- SD, except as otherwise indicated. Statistical analysis was done by means of Fisher's exact test, and p < 0.05 was considered significant. RESULTS: After 5 years from LAP-BAND System surgery, 573 of 3,562 patients were eligible for the study. One hundred fifty-five of 573 (27.0%) were lost to follow-up, 24 of 418 (5.7%) underwent band removal due to complications (gastric pouch dilation, band erosion), eight of 418 (1.9%) were converted to other bariatric procedures, five of 418 (1.2%) died of causes not related to the operation or the band, and 381 of 573 (66.5%) were available for follow-up. Based on 96, 214, 64, and seven patients their preoperative BMI, Were allocated to groups A, B, C, and D, respectively. At time of follow-up mean BMI was 27.5 +/- 5.2 in group A, 31.6 +/- 4.7 in group B, 37.6 +/- 17.3 in group C, and 41.4 +/- 6.9 kg/m(2) in group D. Mean BMI loss was 9.8 +/- 5.4, 12.9 +/- 5.2, 15.8 +/- 8.1, and 23.2 +/- 4.9 kg/m(2), respectively, in groups A, B, C, and D. Mean %EWL at the same time was 54.6 +/- 32.3 in group A, 54.1 +/- 17.2 in group B, 51.6 +/- 35 in group C, and 59.l +/- 17.1 in group D. CONCLUSION: Initial BMI in this series did not correlate with %EWL 5 years after the operation. In fact %EWL was almost the same in each group, independent of preoperative weight. Initial BMI was an accurate indicator of the results obtained 5 years after LAP-BAND in group C (50-59.9 kg/m(2)) and D (=60 kg/m(2)) patients, who remained morbidly obese despite their %EWL.

Laparoscopic banding: selection and technique in 830 patients.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) with the Lap-Band has been our first choice operation for morbid obesity since September 1993. Results in terms of complications and weight loss are analyzed. METHODS: 830 consecutive patients (F 77.9%) underwent LAGB. Initial body weight was 127.9 +/- SD 23.9 kg, and body mass index (BMI) was 46.4 +/- 7.2 kg/m2. Mean age was 37.9 (15-65). Steps in LAGB were: 1) establishment of reference points for dissection (equator of the balloon inflated with 25 cc air and left crus); 2) creation of a retrogastric tunnel above the bursa omentalis; 3) creation of "virtual" pouch; 4) embedding the band. RESULTS: Mortality was 0, conversion 2.7%, and follow-up 97%. Major complications requiring reoperation developed in 3.9% (36 patients). Early complications were 1 gastric perforation (requiring band removal) and 1 gastric slippage (requiring repositioning). Late complications included 17 stomach slippages (treated by band repositioning in 12 and band removal in 5), 9 malpositions (all treated by band repositioning), 4 gastric erosions by the band (all treated by band removal), 3 psychological intolerance (requiring band removal), and 1 HIV positive (band removed). A minor complication requiring reoperation in 91 patients (11%) was reservoir leakage. 20% of patients who had % excess weight loss < 30 had lost compliance to dietetic, psychological and surgical advice. BMI declined significantly from the initial 46.4 +/- 7.2 to 37.3 +/- 6.8 at 1 year, 36.4 +/- 6.9 at 2 years, 36.8 +/- 7.0 at 3 years, and 36.4 +/- 7.8 at 5 years. CONCLUSION: LAGB is a relatively safe and effective procedure.

Anaesthesia for morbidly obese patients: a study of haemodynamic changes during bariatric surgery.

BACKGROUND AND AIMS: Morbid obesity with body mass index (BMI) > 40 kg/m2 requires surgical correction if the diet program fails. Laparoscopic adjustable gastric banding (LAGB) (bariatric surgery) is the standard surgical procedure. The haemodynamic effects of the typical pneumoperitoneum had been studied but, the additional effects of morbid obesity and the consequences of LAGB surgery had not. Therefore, we conducted this study to determine the haemodynamic changes under anaesthesia during bariatric surgery. MATERIALS AND METHODS: Under general anaesthesia, 7 patients (4 males) were studied. Their mean age was 36.2 yr (range 25-50 yr) and mean BMI was 49.7 kg/m2 (range 39.3-67.3). Besides routine monitoring of vital signs, non invasive cardiac output monitor (NICO, Novametrix, Wallingford, CT, USA) was used to monitor cardiac output (CO), cardiac index (CI) and stroke volume (SV). All the haemodynamic variables were taken at three phases: A) after induction of anaesthesia, B) during pneumoperitoneum and C) after gas deflation. RESULTS: The mean HR and BP showed significant high values during phase B compared to phase A. The mean values of CO were 7.2 +/- 1.1 and 9.06 +/- 2.6 L/min during phases A and B respectively with significant differences. The mean values of SV were 91.1 +/- 12.3 and 123.2 +/- 42.6 ml during phases A and B respectively with significant differences. The mean values of CI during phases A and B were 3.1 +/- 0.7 and 3.4 +/- 1.09 L/min/m2 respectively with significant differences. CONCLUSIONS: We have reported high CO and CI during pneumoperitoneum, which may be due to increased heart rate induced by sympathetic stimulation.

Laparoscopic Italian experience with the Lap-Band.

BACKGROUND: An increasing number of surgeons with different levels of experience with laparoscopic surgery and open obesity surgery have started to perform laparoscopic implantation of the Lap-Band. METHODS: An electronic patient data sheet was created and was mailed and e-mailed to all surgeons performing laparoscopic adjustable silicone gastric banding (LASGB) in Italy. Patients were recruited since January 1996. Data on 1,265 Lap-Band System operated patients (258 M/1,007 F; mean BMI 44.1, range 27.0-78.1; mean age 38, range 17-74 years) were collected from 23 surgeons performing this operation. RESULTS: Intra-operative mortality was absent. Post-operative mortality was 0.55% (7 patients) for causes not specifically related to LASGB implantation. The laparotomic conversion rate was 1.7% (22 patients). LASGB related complications occurred in 143 patients (11.3%). Pouch dilatation was diagnosed in 65 (5.2%), and 28 (2.2%) of these underwent re-operation. Band erosion was observed in 24 patients (1.9%). Port or connecting tube-port complications occurred in 54 patients (4.2%), 12 of whom required revision under general anesthesia. Follow-up was obtained at 6, 12, 18, 24, 36 and 48 months, and mean BMI was respectively 38.4, 35.1, 33.1, 30.2, 32.1 and 31.5. The percentage of patients observed at each follow-up was > 60%. There was no intra-operative mortality and no complication-related mortality, with acceptable weight loss. CONCLUSION: The LASGB operation is safe and effective, and deserves wider use for treatment of morbid obesity.

Laparoscopic gastroplasty (adjustable silicone gastric banding).

Until now, for treatment of morbid obesity in the long term, surgery remained as the final option. For 40 years, surgeons looked at the best procedure. Among the restrictive procedures (gastroplasty), the laparoscopic adjustable silicone banding is the least invasive surgical treatment of morbid obesity. Between October 1992 and January 1998, we performed this procedure on 652 patients. Median body mass index was 45 (range, 35-65). Median hospital stay was 3 days (range, 2-10 days). The mean operative time was 80 minutes (range, 40-240 minutes). Four patients (0.6%) presented early complications: bleeding (1 patient), gastric perforation (2 patients), and pneumonia (1 patient). Forty-seven (7.2%) patients presented late complications and needed to be reoperated. There is one case of mortality. Loss of mass body weight was 62% in 2 years. According to these results, laparoscopic adjustable silicone gastric banding seems to be a safe and efficient technique.

Variation in lipid levels in morbidly obese patients operated with the LAP-BAND adjustable gastric banding system: effects of different levels of weight loss.

BACKGROUND: A moderate weight loss is known to improve the lipid levels in simple obesity. The extent of weight loss needed to achieve a clinically meaningful effect on lipid abnormalities in morbid obesity is little understood. We analyzed the effects of different levels of body weight loss on the lipid levels of morbidly obese patients operated with the LAP-BAND System. METHODS: 225 morbidly obese patients (172 F and 53 M) in which a complete lipid profile has been collected both before and 12-18 months after surgery were studied. The changes of the lipid profile were analyzed according to different levels of percent weight loss (%WL: <10%, 10-20%, 20-30%, >30%). RESULTS: Mean weight loss was 30.7+/-15.2 kg, corresponding to a 23.1+/-9.7% reduction of body weight. A large variability in the weight loss was observed. A significant difference in the change of the lipid parameters between the group with <10%WL and the group with 10-20%WL was observed for total-cholesterol (+10.0+/-17.2% vs -0.7+/-14.7%; p<0.05), for the LDL (+18.7+/-26.3% vs +3.1+/-22.9%; p<0.05), and for the triglycerides (+7.7+/-26.3% vs -21.9+/-25.4%; p<0.05). No further significant differences were found between the two groups with greater weight loss (20-30%WL and >30%WL) and the group with 10-20%WL, the only exception being the percent change in triglycerides levels, i.e. higher in the group with %WL >30 (-33.6+/-31.5% vs -21.9+/-25.4%; p<0.05). CONCLUSION: A moderate weight loss of 10-20% of initial body weight produced the maximal effects on the lipid levels in morbid obesity.

Influence of age and menopausal status on pathologic and biologic features of breast cancer.

The distribution of the main prognostic factors in different age groups was evaluated in 1226 patients operated on for primary breast cancer, in order to identify those influenced by age and/or menopausal status. Patients were divided into the following groups: 1) 40 years of age and under; 2) premenopausal over 40 years of age; 3) postmenopausal under 75 years of age and 4) 75 years of age and over. Our findings showed that the youngest patients had the worst prognostic pattern, which improves as age increases and is the best in patients over 75 years of age. Some of the parameters investigated (tumour size, histologic and nuclear grade, tumour infiltrating lymphocytes, p53 and Ki 67) were found to be influenced by age, some (necrosis and oestrogen receptors) were influenced by menopausal status and/or age, some (vascular invasion, ploidy, S-phase and progesterone receptors) showed significant differences in different age groups but there was no consistent relation with patient age or menopausal status, and others (node status, ErbB2/Neu and Cathepsin D) were not influenced by age or menopause.

[Towards a protocol for the good use of the day hospital: an analysis of the level of the care supplied]. / Verso un protocollo per il buon uso del Day Hospital: analisi del livello di assistenza fornita.

Day hospital (DH) is an intermediate way of assistance between ambulatory activity and ordinary hospitalization, with the object of increasing efficiency of hospital services. Nowadays data about real efficiency of DH use are lacking, but probably inappropriateness of DH use is high. Aim of our study has been to analyze the complexity of the services provided by DH in our hospital in 1996. Therefore, we have analyzed 100 case sheets, regarding medical DHs, selected at random among the DHs performed in the year. Our analysis has evidenced that 67.7% of DHs had only one access and in 37% of accesses only one service has been performed. 31.1% of DHs required only clinical evaluation, laboratory analyses, ECG or chest X-ray. 59% of DHs had diagnostic reasons, only 10% therapeutic reasons. Only in 35 of the 75 patients who used DH (46.6%), DH was the only recovery in the year, the others have been recovered more than one (from 1 to 6). In conclusion, our data show that complexity of DH is low and that DH seems substitute ambulatory services rather than ordinary hospitalization.

The world's first obesity surgery performed by a surgeon at a distance.

BACKGROUND: In recent years, laparoscopic procedures have gained popularity. The laparoscopic technique is, however, more difficult than the conventional approach, especially in obese patients. The purpose of this article is to demonstrate a solution to these difficulties. METHOD: On September 16, 1998, a laparoscopic gastric banding procedure was performed by a surgeon while he was actually sitting at a distance from his patient. The surgeon's assistant was scrubbed and gowned and stood at the patient's side. The surgeon manipulated handles that were connected to a computer in command of robotic arms mounted on the operating table near the patient. The robotic arms contained surgical tools with articulated tips, well inside the abdominal cavity. The system constituted a master-slave construction called Mona (Intuitive Surgical, Mountain View, CA). The entire procedure (adjustable silicone gastric banding) was performed solely by this system without any other intervention. RESULTS: The entire procedure lasted 90 minutes. The blood loss was 25 mL. The patient left the hospital on the second postoperative day. CONCLUSION: This procedure demonstrates that telesurgical procedures are feasible, can be performed safely even in obese patients, and improve the surgeon's comfort by restoring ergonomically acceptable conditions, by increasing the number of degrees of freedom, and by recreating the eye-hand connection lost in videoendoscopic procedures.

Bariatric analysis and reporting outcome system (BAROS) applied to laparoscopic gastric banding patients.

BACKGROUND: The definition of success and failure of a bariatric procedure should include weight loss as well as improvement in comorbidity and quality of life assessment. The Bariatric Analysis and Reporting Outcome System (BAROS), introduced by Oria and Moorhead in 1997, seems to provide a standard for comparison in the surgical treatment of morbid obesity. METHODS: 180 morbidly obese and super-obese patients, who underwent laparoscopic gastric banding (lap-band) at our institutions and had a follow-up >18 months (19-55 months) were evaluated with BAROS. RESULTS: The patients were divided into four outcome groups (failure, fair, good, and excellent) based on a scoring table that adds or subtracts points while evaluating three main areas: percentage of excess weight loss, changes in medical conditions, and assessment of quality of life. Points were deducted for complications and reoperative surgery. CONCLUSIONS: The BAROS outcome system has proved to be a useful instrument in evaluating midterm results in our series of lap-band patients.

A randomized, controlled, clinical study of laparoscopic vs open tension-free inguinal hernia repair.

BACKGROUND: The aim of this prospective, randomized, controlled clinical study was to compare laparoscopic transabdominal preperitoneal (TAPP) hernia repair with a standard tension-free open mesh repair (open). METHODS: A total of 108 low-risk patients with unilateral (primary or recurrent) or bilateral hernias were randomized to TAPP (group 1 = 52 cases) or open (group 2 = 56 cases). The outcome measures included operating time, complications, postoperative pain, return to normal activity, operating theater costs, and recurrences. RESULTS: The mean operative time was longer for the TAPP than for the open group only in unilateral primary hernias. At rest, the median Visual Analog Scale (VAS) score was higher for group 1 than group 2 at 48 h postoperatively. Mild to discomforting pain in the inguinal region after 7 days, night pain after 30 days, and inguinal hardening after 3 months were more frequent in group 2 than group 1. No significant differences were observed in return to normal activities between the groups. One hernia recurrence was observed after 1 month in group 1. TAPP was significantly more expensive than open. CONCLUSIONS: TAPP was associated with less postoperative pain than open. The increase in operating theater costs, however, was dramatic and was not compensated by shorter time away from work. TAPP should not be adopted routinely unless its costs can be drastically reduced.

Laparoscopic adjustable silicone gastric banding (Lap-Band): how to avoid complications.

BACKGROUND: The laparoscopic application of LAP-BAND is gaining widespread acceptance as a gastric restrictive procedure. At the same time the reported morbidities (i.e., gastric perforation, stomach and/or band slippage) are cause for some concern. METHODS: From September 1993 until May 1997, 260 patients underwent LAP-BAND at the Department of Surgery at the University of Padova, Italy. RESULTS: The mortality rate was zero and the morbidity rate requiring reoperation was 3.4% (stomach slippage, gastric perforation, erosion). In order to avoid complications the key points of the technique are reviewed: (1) reference points for dissection (equator of the balloon, left crus); (2) retrogastric tunnel within the layers of the phrenogastric ligament; (3) embedment of the band; (4) proper outlet calibration; and (5) retention sutures. CONCLUSIONS: Attention to technical details is of paramount importance for a safe, standardized and effective operation.