Nicola Basso

Effectiveness of Laparoscopic Sleeve Gastrectomy (First Stage of Biliopancreatic Diversion with Duodenal Switch) on Co-Morbidities in Super-Obese High-Risk Patients

Background: We evaluated laparoscopic sleeve gastrectomy (LSG) on major co-morbidities (hypertension, type 2 diabetes / impaired glucose tolerance, obstructive sleep apnea syndrome (OSAS) and on American Society of Anesthesiologists (ASA) operative risk score in high-risk super-obese patients undergoing two-stage laparoscopic biliopancreatic diversion with duodenal switch (LBPD-DS). Methods: 41 super-obese high-risk patients (mean BMI 57.3±6.5 kg/m2, age 44.6±9.7 years) were entered into a prospective study (BMI ≥60, or BMI ≥50 with at least two severe co-morbidities, no Prader-Willi syndrome, no conversion, minimum follow-up 12 months). 9 patients had BMI ≥60. 17 patients (41.4%) had OSAS on C-PAP therapy. In 10 patients, at least one intragastric balloon had been positioned and 4 had undergone laparoscopic adjustable gastric banding, all with unsatisfactory results. At surgery, 41.5% were classified ASA 4 and 58.5% as ASA 3 (mean ASA score 3.4±0.5). Patients underwent evaluation every 3 months postoperatively and were restaged at 12 months and/or before the second step. Results: 60% of major co-morbidities were cured and 24% improved. Average BMI after 6 and 12 months was 44.5±8.1 and 40.8±8.5 respectively (mean follow-up 22.2±7.1 months). After 12 months, 57.8% of the patients were co-morbidity-free and 31.5% had only one major co-morbid condition. At restaging, 20% of patients were still classified as ASA score 4 (OSAS on C-PAP therapy). 3 patients showed BMI <30 and were co-morbidity-free 12 months after LSG. Conclusions: LSG represents a safe and effective procedure to achieve marked weight loss as well as significant reduction of major obesity-related co-morbidities. The procedure reduced the operative risk (ASA score) in super-obese patients undergoing two-stage LBPD-DS.

BioEnterics Intragastric Balloon: The Italian Experience with 2,515 Patients

Background: The temporary use of the BioEnterics Intragastric Balloon (BIB) in morbidly obesity is increasing worldwide. The aim of this study is the evaluation of the efficacy of this device in a large population, in terms of weight loss and its influence on co-morbidities. Methods: Data were retrospectively recruited from the data-base of the Italian Collaborative Study Group for Lap-Band and BIB (GILB). After diagnostic endoscopy, the BIB was positioned and was filled with saline (500-700 ml) and methylene blue (10 ml). Patients were discharged with diet counselling (∼1000 Kcal) and medical therapy. The BIB was removed after 6 months. Positioning and removal were performed under conscious or unconscious sedation. Mortality, complications, BMI, %EWL, BMI loss and co-morbidities were evaluated. Results: From May 2000 to September 2004, 2,515 patients underwent BIB (722M/1,793F; mean age 38.9±14.7, range 12-71; mean BMI 44.4±7.8 kg/m2 ; range 28.0-79.1; and mean excess weight 59.5±29.8 kg, range 16-210). BIB positioning was uncomplicated in all but two cases (0.08%) with acute gastric dilation treated conservatively. Overall complication rate was 70/2,515 (2.8%). Gastric perforation occurred in 5 patients (0.19%), 4 of whom had undergone previous gastric surgery: 2 died and 2 were successfully treated by laparoscopic repair after balloon removal. 19 gastric obstructions (0.76%) presented in the first week after positioning and were successfully treated by balloon removal. Balloon rupture (n=9; 0.36%) was not prevalent within any particular period of BIB treatment, and was also treated by BIB removal. Esophagitis (n=32; 1.27%) and gastric ulcer (n=5; 0.2%) presented in patients without a history of peptic disease and were treated conservatively by drugs. Preoperative co-morbidities were diagnosed in 1,394/2,471 patients (56.4%); these resolved in 617/1,394 (44.3%), improved (less pharmacological dosage or shift to other therapies) in 625/1,394 (44.8%), and were unchanged in 152/1,394 (10.9%). After 6 months, mean BMI was 35.4±11.8 kg/m2 (range 24-73) and %EWL was 33.9±18.7 (range 0-87). BMI loss was 4.9±12.7 kg/m2 (range 0-25). Conclusions: BIB is an effective procedure with satisfactory weight loss and improvement in co-morbidities after 6 months. Previous gastric surgery is a contraindication to BIB placement.

Lap Band adjustable gastric banding system: the Italian experience with 1863 patients operated on 6 years.

Background: The Lap Band system procedure is currently the most common bariatric surgical procedure worldwide. This is an interim report of the experience of the 27 Italian centers participating in the national collaborative study group for Lap Band® (GILB). Methods: An electronic database was specifically created. It was mailed and e-mailed to all of the surgeons now performing the laparoscopic gastric banding operation in Italy. Results: Beginning in January 1996, 1893 patients were recruited for the study. There were 1534 women and 359 men with a mean body mass index (BMI) of (range 30.4–83.6) and a mean age of 37.8 ± 10.9 years (range; 17–74). The mortality rate has been 0.53% (n = 10), mainly due to cardiovascular complications (myocardial infarction, pulmonary embolism). The laparotomic conversion rate has been 3.1% (59/1893) and was higher in superobese patients (BMI>50) than in to morbidly obese patients (BMI <50) (p <0.05). Postoperative complications occurred in 193 patients (10.2%), including tube port failure (n = 79; 40.9%), gastric pouch dilation (GPD) (n = 93; 48.9%), and gastric erosion (n = 21, 10.8%). Most GPD (65.5%) occurred during the first 50 patients treated at each center. The incidence of GPD decreased as the surgeons acquired more experience. Surgery for complications was often performed by laparoscopic access, rarely via laparotomy. No death was recorded as a consequence of surgery to treat complications. Weight loss has been evaluated at the following intervals: 6, 12, 24, 36, 48, 60, and 72 months, with BMI 37.9, 33.7, 34.8, 34.1, 32.7, 34.8, and 32. Conclusions: The Lap Band system procedure has a very low mortality rate and a low morbidity rate and it yields satisfactory weight loss. Surgery for complications can be performed safely via laparoscopic access.

BioEnterics® Intragastric Balloon (BIB®) : a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients

Background:The BioEnterics® Intragastric Balloon (BIB®) System in association with restricted diet has been used for the short-term treatment of morbid obesity. Aim of this study was to evaluate the real, short term, efficacy of the BIB for weight reduction in morbidly obese patients by using a prospective, double-blind, randomised, sham-controlled, crossover study.Methods:Patients were recruited from January 2003 to December 2003. After selection, they were randomly allocated into two groups: BIB followed by sham procedure after 3 months (Group A), and sham procedure followed by BIB after 3 months (Group B). All endoscopic procedures were performed under unconscious intravenous sedation. The BioEnterics Intragastric Balloon (Inamed Health; Santa Barbara, CA, USA) was filled by using saline (500 ml) and methylene blue (10 ml). Patients were discharged with omeprazole therapy and diet (1000 kcal). Patients were followed up weekly by a physician blinded to randomisation. In both groups mortality, complications, BMI, BMI reduction and %EWL were considered. Data were expressed as mean±s.d., except as otherwise indicated. Statistical analysis was performed by means of Students t-test, Fishers exact test or χ 2 with Yates correction; P<0.05 was considered significant.Results:A total of 32 patients were selected and entered the study (8M/24F; mean age: 36.2±5.6 years, range 25–50 years; mean BMI 43.7±1.5 kg/m2, range 40–45 kg/m2; mean %EW: 43.1±13.1, range: 35–65). All patients completed the study. Mortality was absent. Complications related to endoscopy, balloon placement and removal were absent. Mean time of BIB positioning was 15±2 min, range 10–20 min. After the first 3 months of the study, in Group A patients the mean BMI significantly (P<0.001) lowered from 43.5±1.1 to 38.0±2.6 kg/m2, while in Group B patients the decrease was not significant (from 43.6±1.8 to 43.1±2.8 kg/m2). The mean %EWL was significantly higher in Group A than in Group B (34.0±4.8 vs 2.1±1%; P<0.001). After crossover, at the end of the following 3 months, the BMI lowered from 38.0±2.6 to 37.1±3.4 kg/m2 and from 43.1±2.8 to 38.8±3.1 kg/m2 in Groups A and B, respectively.Conclusions:The results of this study show that treatment of obese patients with BioEnterics Intragastric Balloon is a safe and effective procedure. In association with appropriate diet it is significantly effective in weight reduction when compared to sham procedure plus diet. The BIB® procedure can play a role in weight reduction in morbidly obese patients or in the preoperative treatment of bariatric patients.

Prosthetic closure of the esophageal hiatus in large hiatal hernia repair and laparoscopic antireflux surgery

BackgroundLaparoscopy has become the standard surgical approach to both surgery for gastroesophageal reflux disease and large/paraesophageal hiatal hernia repair with excellent long-term results and high patient satisfaction. However, several studies have shown that laparoscopic hiatal hernia repair is associated with high recurrence rates. Therefore, some authors recommend the use of prosthetic meshes for either laparoscopic large hiatal hernia repair or laparoscopic antireflux surgery. The aim of this article was to review available studies regarding the evolution, different techniques, results, and future perspectives concerning the use of prosthetic materials for closure of the esophageal hiatus.MethodsA search of electronic databases, including Medline and Embase, was performed to identify available articles regarding prosthetic hiatal closure for large hiatal or paraesophageal hernia repair and/or laparoscopic antireflux surgery. Techniques and results as well as recurrence rates and complications related to the use of prosthetics for hiatal closure were reviewed and compared. Additionally, recent experiences and recommendations of experienced experts in this field were collected.ResultsThe results of 42 studies were analyzed in this review. Some techniques of mesh hiatal closure were evaluated; however, most authors prefer posterior mesh cruroplasty. The type and shape of hiatal meshes vary from small angular meshes to A-shaped, V-shaped, or complete circular meshes. The most frequently utilized materials are polypropylene, polytetrafluoroethylene, or dual meshes. All studies show a low rate of postoperative hernia recurrence, with no mortality and low morbidity. In particular, comparative studies including two prospective randomized trials comparing simple sutured hiatal closure to prosthetic hiatal closure show a significantly lower rate of postoperative hiatal hernia recurrence and/or intrathoracic wrap migration in patients who underwent prosthetic hiatal closure.ConclusionsLaparoscopic large hiatal/paraesophageal hernia repair with prosthetic meshes as well as laparoscopic antireflux surgery with prosthetic hiatal closure are safe and effective procedures to prevent hiatal hernia recurrence and/or postoperative intrathoracic wrap migration, with low complication rates. The type of mesh, particularly the size and shape, is still controversial and is a matter for future research in this field.

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 occured 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.

CIMETIDINE AND ANTACID PROPHYLAXIS OF ACUTE UPPER GASTROINTESTINAL BLEEDING IN HIGH - RISK PATIENTS

A randomized, controlled clinical trial was performed to compare the efficacy of prophylactic cimetidine treatment, antacid treatment and no treatment in high risk patients. Sixty patients received cimetidine (200 mg every 6 hours), 52 patients received antacids (Maalox, 10 ml/hour), and 56 patients received no treatment. One hundred thirty-five patients completed the study. Eight patients in the control group and one patient in the antacid-treated group presented with upper gastrointestinal bleeding. No bleeding occurred in the cimetidine-treated group. Patients considered at low risk had no bleeding. Cimetidine or antacid prophylaxis significantly decreased the incidence of upper gastrointestinal bleeding in the high risk patients.

360° laparoscopic fundoplication with tension-free hiatoplasty in the treatment of symptomatic gastroesophageal reflux disease

AbstractBackground: Since laparoscopic Nissen fundoplication was first described by Cuschieri in 1989 and later by Dallemagne in 1991, this procedure has been widely employed for the treatment of symptomatic gastroesophageal reflux disease (GERD) and/or hiatal hernia. However, a relatively high incidence (7–11%) of intrathoracic Nissen valve migration/paraesophageal hernia following laparoscopic fundoplication has recently been reported. Methods: Between November 1992 and August 1995, 65 consecutive patients with severe GERD and/or hiatal hernia underwent laparoscopic 360° fundoplication. In nine of these 65 (13.8%) patients, an intrathoracic Nissen valve migration had occurred within 4 months. Six of these patients were symptomatic and were again submitted to the laparoscopic intervention. Videotapes of both the first and second operation were reviewed. In all cases, it was apparent that, at the first operation, closure by stitches of the hiatus was under tension, and at the second operation, the muscle fibers of the right crus were disrupted, probably due to the tension between the suture margins during the inspiratory movements of the diaphragm. These findings prompted us to perform an effective tension-free closure of the hiatus. A polypropylene mesh (3 × 4 cm) was placed on the hiatus behind the esophagus and fixed with eight metallic agraphes (2 + 2 on the superior edge and 2 + 2 on the lateral sides of the right and left cruses). Results: Between August 1995 and February 1998, the technique, complete with 360° fundoplication, was used for 67 patients with GERD. At mean follow-up of 22.5 months (range, 1–30), there was no evidence of postoperative paraesophageal hernia or complications related to the use of the mesh. Conclusions: This tension-free hiatoplasty seems to be an effective solution to prevent postoperative paraesophageal hernia in patients undergoing antireflux laparoscopic surgery. However, longer follow-up is still needed.

Laparoscopic adjustable silicone gastric banding: prospective evaluation of intragastric migration of the lap-band.

Intragastric prosthesis (Lap-Band, BioEnterics Co., Carpinteria, CA, U.S.A.) migration is one of the major long-term complications of laparoscopic adjustable silicone gastric banding. The causes, clinical signs, timing, and overall incidence of band entrapment have not been prospectively investigated in a large series. The purpose of this study was to assess prospectively the incidence of Lap-Band intragastric migration and to establish the safety and effectiveness of minimally invasive band removal. Between January 1996 and June 2000, 148 consecutive patients enrolled in a multidisciplinary bariatric program underwent laparoscopic adjustable silicone gastric banding. In the follow-up treatment, gastrointestinal endoscopy was performed routinely. One hundred twenty-three patients with a minimum follow-up period of 12 months were entered into the study group. Eleven (9.2%) patients had long-term major complications. Intragastric band migration was observed in nine (7.5%) patients. The diagnosis was established by routine endoscopy between 10 and 41 months after surgery. Five erosions occurred in the first 30 cases (learning curve period). In six patients, the band was removed by an intragastric endoscopic-assisted approach avoiding laparotomy. The remaining three patients are under endoscopic surveillance. The results of this study show that routine upper gastrointestinal endoscopy can discover asymptomatic band migrations early. Band erosion did not require emergency treatment and can be removed safely by a minimally invasive approach.

Use of the somatostatin analogue octreotide to localise and manage somatostatin-producing tumours

Background—Somatostatin receptor scintigraphy (SRS) and octreotide therapy have both changed the management of gastroenteropancreatic endocrine tumours, but very few data are available on the use of SRS and octreotide to visualise and treat somatostatinomas. Method—The results of SRS and octreotide treatment in three somatostatinoma patients were examined. Results—SRS was able to detect extensive hepatic involvement in patient 1, one hepatic and one pancreatic lesion in patient 2, and one hepatic lesion in patient 3. Octreotide therapy (0.5 mg/day subcutaneously) was effective in decreasing plasma levels of somatostatin in all three patients. Symptoms (diabetes and diarrhoea) were greatly improved in the two patients with “somatostatinoma syndrome”. Conclusion—The study shows that somatostatinoma, like most other gastroenteropancreatic endocrine tumours, possesses functioning somatostatin receptors.