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 We enrolled 210 patients, of whom 50 were withdrawn preoperatively.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.

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.

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.

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.

The influence of a new timing strategy of band adjustment on the vomiting frequency and the food consumption of obese women operated with laparoscopic adjustable silicone gastric banding (LAP-BAND).

OBJECTIVE: To evaluate the effects of a new timing strategy of band adjustment on the short-term outcome of obese women operated with adjustable silicone gastric banding. SUBJECTS: The outcome of 30 women without binge-eating disorder operated with laparoscopic adjustable silicone gastric banding with a wider intraoperatory band calibration (LAP-BAND) was compared to that of 30 body mass index-matched women without binge-eating disorder previously operated with adjustable silicone gastric banding (ASGB) applied by laparotomy with the usual intraoperatory band calibration. The patients were evaluated 3, 6 and 12 months after surgery. MEASUREMENTS: (1) weight loss; (2) total daily energy intake; (3) percent as liquid, soft or solid food; (4) vomiting frequency; (5) rate of postoperative percutaneous band adjustments; (6) rate of band-related complications. RESULTS: Both the weight loss and the daily energy intake did not differ between patients with LAP-BAND and patients with ASGB. After surgery, the patients with LAP-BAND ate more solid food and less liquid food than the patients with ASGB. Vomiting frequency was higher in patients with ASGB than in patients with LAP-BAND. The total number of percutaneous band adjustments was higher in women with LAP-BAND than in women with ASGB. Band inflation because of weight stabilization was performed in six (20.0%) women with ASGB and in 19 (63.3%) women with LAP-BAND. Neostoma stenosis occurred in one woman with ASGB, but in none of the women with LAP-BAND. One patient with LAP-BAND presented band slippage. CONCLUSIONS: The wider intraoperatory band calibration performed in patients with LAP-BAND did not reduce the short-term efficacy of adjustable silicone gastric banding. This new timing strategy of band adjustment required more postoperative percutaneous band inflations, but it improved the eating pattern of the patients (low vomiting frequency and high intake of solid food).

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.

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.

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.

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.

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.

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.

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.

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.

[Vertical gastroplasty. Evaluation of efficacy]. / La gastroplastica verticale. Valutazione dell'efficacia.

The paper evaluates the results of vertical gastroplasty in the treatment of morbid obesity. A series of 34 patients (24 F and 10 M) with the following characteristics was included in the study: mean age 41 years, preoperative weight 141 kg, % of ideal weight 204%, BMI 49; mean follow-up was 35 months. Postoperative mortality was zero and there were reduced early and long-term complications. Mean weight loss, expressed as a percentage of overweight, at 6 months was 48.5%, 56.8% at 12 months, 63.4% at 24 months and 67.2% at 36 months. The authors conclude that, given the low incidence of complications and the satisfactory weight loss which was maintained long after the operation, vertical gastroplasty appears to be the preferred operation, since it represents a safe and effective method of treating pathological obesity.

[Idiopathic retroperitoneal fibrosis: effectiveness of surgery combined with corticosteroid therapy]. / Fibrosi retroperitoneale idiopatica: efficacia della terapia associata chirurgica e corticosteroidea.

Idiopathic retroperitoneal fibrosis (ERF) is a rare disease characterized by non-neoplastic fibroblastic and inflammatory proliferation. We describe a case of a 58-year-old man presenting with abdominal pain, weight loss and abdominal mass on clinical examination. The patient was evaluated by abdominal CT scan and magnetic resonance imaging which disclosed a periaortic soft-tissue mass with marked longitudinal extension below renal arteries origin. The diagnosis of ERF was histologically confirmed after surgical exploration and biopsies followed by extensive ablation of fibrous tissue. After 6 months of low-doses of postoperative steroid therapy retroperitoneal fibrous tissue had almost disappeared on CT examination.

Regional intra-vascular and intra-lymphatic therapy of neoplastic diseases: a review.

The aims of regional therapy are to increase the exposure of regional confined cancers to drugs and to decrease their systemic levels. Two main approaches are available: intra-vascular and intra-lymphatic (I.L.) therapy. The former is comprised of different methods of delivering chemo-radio therapeutic agents directly to the tumor, i.e. intra-arterial infusion (I.A.I.), isolation perfusion (I.P.), tourniquet infusion (T.I.), trans-catheter embolization (T.C.E.) and intra-portal infusion (I.P.I.). The main aim of the latter is the prevention or cure of lymphatic metastases. So far none of the reported methods have been universally accepted. Pharmacokinetic studies have recently made I.A.I. a more rational method: the increase in regional exposure achieved is a direct function of the total body clearance of a drug and an inverse function of the regional arterial blood flow. I.A.I. is most effective in the treatment of hepatic metastases from carcinoid and colo-rectal cancer. I.P. gives objective response in 50% of recurrent melanomas. T.I., T.C.E., I.P.I. and I.L. therapy are still experimental methods. However, the future for regional therapy appears exciting, since pharmacological and technological developments seem to have greatly improved its potential effectiveness as a cancer treatment.

[Thyroid carcinoma in the young age]. / Il carcinoma tiroideo in età giovanile

Thyroid carcinoma in the young is relatively benign. Lymph node, lung and bone metastases are very frequent. This sets a premium on early diagnosis and at the same time complicates the choice of management. These wellcombined surgical and radiation treatment is therefore recommended.

Feasibility of outpatient surgery in the tropics.

The feasibility of outpatient surgery was investigated at a regional hospital in a Third World country. A series of 73 patients with uncomplicated hernias (inguinal, femoral) and hydroceles were allocated at random to receive standard surgical treatment either as inpatients (group 1) or as outpatients (group 2). Patients living within a 4 km radius of the hospital or who agreed to stay in specially provided quarters nearby were eligible to take part in the study. Patients not able to follow the basic hygiene rules taught by the local staff were excluded. The morbidity rate was 5/36 (13.8%) in group 1 and 8/37 (21.6%) in group 2. No statistically significant differences were demonstrated between the complications that occurred in the two groups.

[Peptic ulcer: proposal of a data collection chart for electronic processing]. / Ulcera peptica: proposta di una cartella raccolta dati da sottoporre ad elaborazione elettronica.

Given the high incidence of peptic-ulcer disease and the need to develop an adequate means of assessment of medical-surgical treatments, the Authors propose a clinical record card for computer processing.