Safety and Efficacy of a New Swallowable Intragastric Balloon Not Needing Endoscopy: Early Italian Experience.

PURPOSE: The aim of this study was to evaluate the safety and efficacy of a new intragastric balloon (Elipse™ Balloon, Allurion Technologies, Natick, MA USA) not needing endoscopy. MATERIALS AND METHODS: The balloon was swallowed under fluoroscopy in 38 consecutive patients (F/M 28/10, mean age 46.4 ± 10.6 years, mean weight 109.7 ± 21.9 kg, and mean body mass index (BMI) 38.6 ± 6.7 kg/m2). After 4 months, the balloon spontaneously emptied and it was excreted through the digestive tract without upper endoscopy. RESULTS: There were no complications during balloon passage. After 16 weeks, the mean weight loss was 12.7 kg, mean percent excess weight loss was 26%, and mean BMI reduction was 4.2 kg/m2. Total body weight loss was 11.6%. There was a significant reduction in major co-morbidities related to metabolic syndrome: blood pressure (p < 0.02), waist circumference (p < 0.002), triglycerides (p < 0.0001), blood glucose (p < 0.001), and HOMA-IR index (p < 0.001). At the end of the treatment, 37 balloons were naturally excreted in the stool, and one balloon was endoscopically removed. CONCLUSIONS: The results of this study on 38 consecutive patients demonstrate that the Elipse™ Balloon is safe, effective, and very well accepted by patients.

Changes in insulin sensitivity and secretion after sleeve gastrectomy.

BACKGROUND: Sleeve gastrectomy is indicated for the treatment of obesity and related co-morbidity including diabetes. The dynamic changes in insulin secretion and sensitivity after sleeve gastrectomy are unknown. METHODS: Whole-body insulin sensitivity was measured by the euglycaemic hyperinsulinaemic clamp technique, and insulin secretion by C-peptide deconvolution after an oral glucose tolerance test (OGTT), before and 3, 6 and 12 months after sleeve gastrectomy in morbidly obese subjects. The time course of glucagon-like peptide (GLP) 1, as a marker of insulin secretion following OGTT, was also assessed. RESULTS: Ten patients were included in the study. Median (range) baseline insulin sensitivity (M-value) increased from 84.0 (20.2-131.4) mmol per kg per min at baseline to 122.8 (99.0-179.3) mmol per kg per min at 12 months after surgery (P = 0.015). Fasting insulin sensitivity, measured by homeostatic model assessment of insulin resistance, which represents a surrogate index of hepatic insulin resistance, decreased from 3.3 (1.9-5.5) to 0.7 (0.5-1.1) mg/dl · µunits/ml (P < 0.001). Total insulin secretion, measured as incremental area under the curve (AUC), after OGTT decreased from 360.4 (347.9-548.0) to 190.1 (10.1-252.0) mmol/l · 180 min at 12 months (P = 0.011). The AUC for GLP-1 increased from 258.5 (97.5-552.6) to 5531.8 (4143.0-7540.9) pmol/l · 180 min at 12 months after sleeve gastrectomy (P < 0.001). In multiple regression analysis, 51 per cent of the M-value variability was explained by GLP-1 secretion. CONCLUSION: Sleeve gastrectomy improved insulin sensitivity and reduced insulin secretion within 6 months after surgery. Although there was a correlation between insulin sensitivity and bodyweight, the major driver of the improvement in insulin sensitivity was GLP-1 secretion.

Laparoscopic sleeve gastrectomy as first stage or definitive intent in 300 consecutive cases.

BACKGROUND: Laparoscopic sleeve gastrectomy (SG) was originally used as a bridge to definitive surgery in high-risk patients. Recently it has been considered as a stand-alone procedure due to its effectiveness on weight loss and comorbidities resolution. This study was designed to evaluate the results of SG on complications, body mass index (BMI), and comorbidities resolution in 300 consecutive obese patients and to analyze the lesson learned from this experience. METHODS: From October 2002 to November 2009, 300 patients underwent SG. In the first 100 cases (group 1: mean BMI, 54.4±9.3), SG was intended as a first stage of biliopancreatic diversion with duodenal switch in high risk super-obese patients. In the last 200 cases (group 2: mean BMI, 45.5±7.3), SG was intended as a definitive procedure. No routine reinforcement was performed in group 1. In group 2, oversewn reinforcement was performed routinely. SG was redo surgery in 21 patients (7%). RESULTS: Mean operative time was 119±48.6 min in group 1 and 72±33.8 in group 2. Conversion rate was 0.6% (massive hepatomegaly). Mortality was 0.6%. Major postoperative complications were registered in 15 patients in group 1 and 11 in group 2. In 3 cases, a reoperation was needed. The mean BMI in group 1 was 46, 43, 39, and 31 at 6, 12, 24, and 36 months, respectively. In group 2, the mean BMI was 32.9, 30.6, and 31.7 at 6, 12, and 18 months. At 12 months, the diabetes, hypertension, and OSAS were cured on 69%, 62%, and 50% in group 1 and 88%, 57%, and 58% in group 2. In group 2, no patient required second stage. CONCLUSIONS: SG is a safe and effective treatment for morbid obesity at mid-term follow-up. SG is effective for comorbidities resolution, especially for the treatment of diabetes. Suture line reinforcement allows a significant reduction of bleeding.

Long-term results of hiatal hernia mesh repair and antireflux laparoscopic surgery.

BACKGROUND: Laparoscopic antireflux surgery (LARS) represents the gold standard in the treatment of gastroesophageal reflux disease with or without hiatal hernia. It offers excellent long-term results and high patient satisfaction. Nevertheless, several studies have reported a high rate of intrathoracic wrap migration or paraesophageal hernia recurrence. To reduce the incidence of this complication, the use of prosthetic meshes has been advocated. This study retrospectively evaluated the long-term results of LARS with or without the use of a mesh in a series of patients treated from 1992 to 2007. METHODS: From November 1992 to May 2007, 297 patients underwent laparoscopic antireflux surgery in the authors' department. Crural closure was performed by means of two or three interrupted nonabsorbable sutures for 93 patients (group A), by tailored 3 x 4-cm polypropylene mesh placement for 113 patients (group B), and by nonabsorbable suture plus superimposed tailored mesh for 91 patients (group C). RESULTS: The mean follow-up period for the entire group was 95.1 +/- 38.7 months, specifically 95.2 +/- 49 months for group A, 117.6 +/- 18 months for group B, and 69.3 +/-.17.6 months for group C. Intrathoracic Nissen wrap migration or hiatal hernia recurrence occurred for nine patients (9.6%) in group A, two patients (1.8%) in group B, and only one patient (1.1%) in group C. Esophageal erosion occurred in only one case (0.49%). Functional results and the long-term quality-of-life evaluation after surgery showed a significant and durable improvement with no significant differences related to the type of hiatoplasty. CONCLUSION: Over a long-term follow-up period, the use of a prosthetic polypropylene mesh in the crura for hiatal hernia proved to be effective in reducing the rate of postoperative intrathoracic wrap migration or hernia recurrence, with a very low incidence of mesh-related complications.

Nonsurgical treatment of staple line leaks after laparoscopic sleeve gastrectomy.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is gaining popularity as a "per se" bariatric procedure due to its effectiveness on weight loss and comorbidity resolution. The most feared and life-threatening complication after LSG is the staple line leak and its management is still a debated issue. Aim of this paper is to analyze the incidence of leak and the treatment solutions adopted in a consecutive series of 200 LSG. METHODS: From October 2002 to November 2008, 200 patients underwent LSG. Nineteen patients (9.5%) had a body mass index (BMI) of >60 kg/m(2). A 48-Fr bougie is used to obtain an 80-120-ml gastric pouch. An oversewing running suture to reinforce the staple line was performed in the last 100 cases. The technique adopted to reinforce the staple line is a running suture taken through and through the complete stomach wall. RESULTS: Staple line leaks occurred in six patients (mean BMI 52.5; mean age 41.6 years). Leak presentation was early in three cases (first, second, and third postoperative (PO) day), late in the remaining three cases (11th, 22nd, and 30th PO day). The most common leak location was at the esophagogastric junction (five cases). Mortality was nihil. Nonoperative management (total parenteral nutrition, proton pump inhibitor, and antibiotics) was adopted in all cases. Percutaneous abdominal drainage was placed in five patients. In one case, a small fistula was successfully treated by endoscopic injection of fibrin glue only. Self-expandable covered stent was used in three cases. Complete healing of leaks was obtained in all patients (mean healing time 71 days). CONCLUSION: Nonoperative treatment (percutaneous drainage, endoscopy, stent) is feasible, safe, and effective for staple line leaks in patients undergoing LSG; furthermore, it may avoid more mutilating procedures such as total gastrectomy.

Two-stage laparoscopic biliopancreatic diversion with duodenal switch as treatment of high-risk super-obese patients: analysis of complications.

INTRODUCTION: The aim of this study is to retrospectively analyze the incidence of complications after two-stage laparoscopic biliopancreatic diversion with duodenal switch (Lap BPD-DS) in high-risk super-obese patients and explore the possible predictive factors of specific complications after laparoscopic sleeve gastrectomy (SG). METHODS: High-risk patients--body mass index (BMI) > 50 kg/m(2) with at least two major comorbidities: type 2 diabetes, obstructive sleep apnea syndrome (OSAS), hypertension--undergoing two-stage laparoscopic BPD-DS were retrospectively analysed. The SG pouch volume was 100-150 ml; in the second stage, the common channel and the alimentary loop were 100 cm and 150 cm, respectively. RESULTS: Eighty-seven patients (50 female, 57.5%) underwent SG (two open). The mean age was 41.8 +/- 10.22 years with BMI of 55.2 +/- 6.69 kg/m(2). Four patients had Prader-Willy syndrome. Fourteen (16.46%) patients (6 female, 42.8%) had postoperative complications such as bleeding, fistula, pulmonary embolism, transitory acute renal failure, and abdominal abscess. One patient died at postoperative day 5 of pulmonary embolism. One patient was reoperated for hemoperitoneum by laparoscopy. The risk of complications after SG was lower in patients where reinforcement of the suture line was used (0.492), while it was higher in men (1.780). Neither difference was statistically significant [p = not significant (NS)]. After 9-24 months, 27 patients (BMI 43 +/- 8 kg/m(2)) underwent a second stage of BPD-DS (two open). Major postoperative complications were registered in eight patients (29.6%): three bleeding, four duodeno-ileal stenosis and one rhabdomyolysis. Two cases of internal hernia required laparoscopic reoperation. The reoperation rate was 1/85 (1.2%) after SG and 2/27 (7.4%) after second stage. CONCLUSIONS: Complications after SG greatly decrease after the learning curve period and can be successfully managed without need of reoperation. Suture-line reinforcement, at least selectively in the middle-upper portion of the staple line and in super-super-obese patients, is recommended to decrease the incidence of specific complications.