Multisite study of Titan SGS stapler in longitudinal gastric resection.

BACKGROUND: Standardization of the laparoscopic sleeve gastrectomy procedure is needed to improve patient outcomes. A single-fire 23 cm stapler was developed to streamline the operation. Comparative testing conducted on excised human tissue has demonstrated the superiority of the novel Titan SGS stapler to two commonly utilized commercial devices in both staple line integrity and burst pressure. We hypothesized that the stapler would be safe and effective in creating longitudinal gastric resections in human patients. METHODS: 61 patients were enrolled to undergo gastric resection with the Titan SGS stapler. Perioperative interventions and post-operative adverse events were recorded. Upper GI study was completed on post-operative day 1, and patients were followed for 6 weeks post-operatively to determine any subacute device-related adverse events. RESULTS: Surgeon feedback for intraoperative device utilization and post-operative gastric pouch shape were positive. Adverse events were found to be mild, limited, and generally well-known effects of bariatric surgery. One episode of post-operative hemorrhage required surgical takeback, with no criminal bleeding vessel identified. CONCLUSION: The Titan SGS stapler is both safe and effective in sleeve gastrectomy pouch creation.

Surprising neutral effect of shorter staple cartridges in laparoscopic sleeve gastrectomy.

BACKGROUND: Consensus agreements regarding laparoscopic sleeve gastrectomy (LSG) advise against using staple loads less than 1.5 mm in closed staple height. However, few data exist to support this recommendation. We hypothesized that using staples with a shorter closed height would actually decrease incidence of intraoperative and postoperative bleeding during LSG, while not increasing the incidence of leak. METHODS: All LSG cases for a single institution from 1/1/2014 to 12/31/2019 were exported for analysis. Two cohorts were established: 1. 'Green/Blue' group was cases in which no white cartridges were used and 2. 'White' group was cases in which any white cartridges were used. Demographic variables, procedural characteristics, hospital length of stay, and postoperative outcomes were compared between groups. RESULTS: The study populations included 1710 patients, 974 in the green/blue group and 736 in the white cartridge group. There were no significant differences in postoperative leak, bleed, stricture, readmission, or death while using white staple loads as compared with the standard combination of blue and green loads. CONCLUSION: Using staples with a shorter closed height during LSG did not impact the postoperative bleeding or leak rate. The impact from selection of shorter staples to achieve more tissue compression may be limited.

The impact of sleeve gastrectomy on renal function in patients with chronic kidney disease varies with severity of renal insufficiency.

BACKGROUND: Although laparoscopic sleeve gastrectomy is known, in general, to improve renal function in patients with obesity and chronic kidney disease (CKD), its effect on estimated glomerular filtration rate (eGFR) stratified by the stage of CKD is less clear. OBJECTIVES: We aimed to evaluate the impact of sleeve gastrectomy on renal function in a stratified cohort of patients with CKD. SETTING: University Hospital. METHODS: We performed a retrospective review of 1932 patients who met National Institutes of Health's guidelines for metabolic surgery and underwent laparoscopic sleeve gastrectomy performed by 1 of 3 surgeons. One hundred sixty-four patients with CKD stages 1 through 4 were identified. RESULTS: Mean follow-up period was 1.57 ± 1.0 years. Mean age was 56.4 ± 9.9 years with a preoperative body mass index of 47 ± 9 kg/m2, which decreased to 38.9 ± 8.7 kg/m2 at most recent follow-up (P < .001). In the cohort of patients with diabetes, significant decreases were observed in mean glycated hemoglobin level, daily number of oral hypoglycemics, and daily long acting insulin use (P < .001 each). Of 67 patients with diabetes, 34.3% (n = 24) achieved complete remission. In patients with hypertension, average daily number of antihypertensives decreased (P < .001) and 22.3% (n = 31) of 133 patients with hypertension discontinued all antihypertensives. Patients with CKD stages 2, 3a, and 3b showed significant improvement in eGFR. Reinforcing this evidence of improvement, patients with CKD 3a and 3b were more likely to downstage disease compared with those with CKD 4 (58.1% versus 73.1% versus 22.7%, respectively) (P < .001). CONCLUSION: Renal function, as measured by eGFR, in patients with stages 1 and 4 CKD did not improve after laparoscopic sleeve gastrectomy; in contrast, eGFR in patients with CKD stages 2 and 3 significantly improved. Early surgical referral and intervention may be important in achieving the greatest improvement in eGFR and possibly delaying or reversing progression to end-stage renal disease.

Enhanced Recovery Protocol for Laparoscopic Sleeve Gastrectomy: Are Narcotics Necessary?

BACKGROUND: Enhanced recovery after surgery (ERAS) protocols have improved patient experience and outcomes in a variety of fields, including bariatric surgery. Given the increasing opioid epidemic in the USA, we sought to determine the impact of our own ERAS protocol on narcotic usage following laparoscopic sleeve gastrectomy. METHODS: Retrospective chart review was performed on patients undergoing primary laparoscopic sleeve gastrectomy for 6 months before and after implementation of an ERAS protocol. Our protocol strongly discouraged the use of narcotics in the postoperative period. Specific outcomes of interest were postoperative narcotic usage, length of stay, complications, and readmissions. RESULTS: Patient characteristics were similar in the two groups. ERAS implementation did not correlate with changes in length of stay, complications, or readmissions. However, ERAS implementation was associated with dramatic reductions in the use of intravenous narcotics (100% vs 47%, p < 0.01) and oral schedule 2 narcotics (56% vs 6%, p < 0.01), with an increase in the usage of tramadol (0% vs 36%, p < 0.01). After ERAS implementation, 52% of patients were managed without the use of schedule 2 narcotics (0% pre-ERAS, p < 0.01) and 33% received no narcotics of any kind (0% pre-ERAS, p < 0.01). CONCLUSION: Implementation of an ERAS protocol for laparoscopic sleeve gastrectomy is associated with a dramatic reduction in the use of narcotics in the postoperative period. This has implementation for the usage of narcotics for laparoscopic surgery and potential elimination of narcotics for certain patients and procedures.

What matters after sleeve gastrectomy: patient characteristics or surgical technique?

BACKGROUND: The impact of operative technique on outcomes in laparoscopic sleeve gastrectomy has been explored previously; however, the relative importance of patient characteristics remains unknown. Our aim was to characterize national variability in operative technique for laparoscopic sleeve gastrectomy and determine whether patient-specific factors are more critical to predicting outcomes. METHODS: We queried the database of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program for laparoscopic sleeve gastrostomies performed in 2015 (n = 88,845). Logistic regression models were used to determine predictors of postoperative outcomes. RESULTS: In 2015, >460 variations of laparoscopic sleeve gastrectomy were performed based on combinations of bougie size, distance from the pylorus, use of staple line reinforcement, and oversewing of the staple line. Despite such substantial variability, technique variants were not predictive of outcomes, including perioperative morbidity, leak, or bleeding (all P ≥ .05). Instead, preoperative patient characteristics were found to be more predictive of these outcomes after laparoscopic sleeve gastrectomy. Only history of gastroesophageal disease (odds ratio 1.44, 95% confidence interval 1.08-1.91, P < .01) was associated with leak. CONCLUSION: Considerable variability exists in technique among surgeons nationally, but patient characteristics are more predictive of adverse outcomes after laparoscopic sleeve gastrectomy. Bundled payments and reimbursement policies should account for patient-specific factors in addition to current accreditation and volume thresholds when deciding risk-adjustment strategies.

Laparoscopic sleeve gastrectomy in adolescents with or without syndromic obesity: two years follow-up.

INTRODUCTION: Childhood obesity is an emerging health problem. Surgical treatment of obese adolescents, particularly those affected by congenital syndrome, represents a controversial issue. The aim of this multicenter study was to retrospectively assess the results of laparoscopic sleeve gastrectomy (LSG) in a cohort of adolescents affected by morbid obesity, with or without congenital syndromes. MATERIALS AND METHODS: Forty-one obese (BMI 49 ± 6 kg/m2) adolescents with mean age of 16 ± 3 years (58.5% with previous intragastric balloon failure), and subjected to LSG, were retrospectively evaluated for complications rate, % excess weight loss (%EWL), and inhibition of co-morbidities after 2 years of follow-up. RESULTS: All the operations were completed laparoscopically and no intra-operative complications were recorded. No mortality was recorded while peri- or post-operative complications only occurred in two patients (4.9%). The EWL% at 6, 12, and 24 months were 42.3, 58.3, and 59.4, respectively. %EWL was comparable (p = 0.7) between non-syndromic and syndromic obese adolescents at 24 months. Conversely patients with previous intragastric balloon surgery had a significant lower EWL (%) at 24 month (p < 0.01). Moreover, at the same time point, co-morbidity resolution rate was 78.2% while improvement rate was 57.6%. Specifically, remission rate of type 2 diabetes (T2DM), hypertension and obstructive sleep apnea (OSA) were 71, 75 and 61%, respectively. CONCLUSION: LSG is advantageous in the treatment of morbidly obese juveniles concerning safety, weight loss and co-morbidity control and at same time presenting, a possible effective therapeutic option for patients affected by congenital syndrome.

Leaks after laparoscopic sleeve gastrectomy: overview of pathogenesis and risk factors.

BACKGROUND: Leak is the second most common cause of death after bariatric surgery. The leak rate after laparoscopic sleeve gastrectomy (LSG) ranges between 1.1 and 5.3 %. The aim of the paper is to provide an overview of the current pathogenic and promoting factors of leakage after LSG on the basis of recent literature review and to report the evidence based preventive measures. METHODS: Risk factors and pathogenesis of leakage after LSG were examined based on an extensive review of literature and evidence based analysis of the most recent published studies using Oxford centre for evidence-based medicine, 2011, levels of evidence. RESULTS: Pathogenesis of leakage after LSG can be attributed to mechanical or ischemic causes. Many factors can predispose to leakage after LSG which are either technically related or patient related. Awareness of these predisposing factors and technical tips may decrease the incidence of leakage. CONCLUSIONS: This review reports factors promoting leak and gives technical recommendations to avoid leak after LSG based on the available evidence and expert consensus which encompasses: (1) use a bougie size ≥40 Fr, EL:1, (2) begin the gastric transection 5-6 cm from the pylorus, EL:2-3, (3) use appropriate cartridge colors from antrum to fundus, EL:1, (4) reinforce the staple line with buttress material, EL:1, (5) follow a proper staple line, (6) remove the crotch staples, EL:4, (7) maintain proper traction on the stomach before firing, (8) stay away from the angle of His at least 1 cm, EL:1, (9) check the bleeding from the staple line, (10) perform an intraoperative methylene blue test, EL:4.

Incisionless revision of post-Roux-en-Y bypass stomal and pouch dilation: multicenter registry results.

BACKGROUND: Surgical revision for weight regain after Roux-en-Y gastric bypass (RYGB) has been tempered by the high complication rates associated with standard approaches. Endoluminal revision of stoma and pouch dilation should intuitively confer a better risk profile. However, questions of clinical safety, durability, and weight loss need to be answered. We report our multicenter intraoperative experience and postoperative follow-up to date using the Incisionless Operating Platform for this patient subset. METHODS: The patients who had regained significant weight >or=2 years after RYGB after losing >or=50% of excess body weight after RYGB were endoscopically screened for stomal and/or pouch dilation. Qualified patients underwent incisionless revision using the Incisionless Operating Platform to reduce the stoma and pouch size by placing anchors to create tissue plications. Data on the safety, intraoperative performance, postoperative weight loss, and anchor durability were recorded to date as a part of 2 years of postoperative follow-up. RESULTS: A total of 116 consecutive patients were prospectively studied. Anchors were successfully placed in 112 (97%) of 116 patients, with an average intraoperative stoma diameter and pouch length reduction of 50% and 44%, respectively. The operating room time averaged 87 minutes. No significant complications occurred. At 6 months after the procedure (n = 96), an average of 32% of weight regain that had occurred after RYGB had been lost. The percentage of excess weight loss averaged 18%. The 12-month esophagogastroduodenoscopy results confirmed the presence of the anchors and durable tissue folds. CONCLUSIONS: Incisionless revision of stoma and pouch dilation using the Incisionless Operating Platform can be performed safely. The data to date have demonstrated mild-to-moderate weight loss, and the early 12-month endoscopic images have confirmed anchor durability. Patients were actively followed up to document the long-term durability of this intervention in the entire patient subset.

Safety and effectiveness of bariatric surgery: Roux-en-y gastric bypass is superior to gastric banding in the management of morbidly obese patients: a response.

BACKGROUND: The recent article by Guller, Klein, Hagen was reviewed and discussed by the authors of this response to critically analyze the validity of the conclusions, at a time when patients and providers depend on peer reviewed data to guide their health care choices. The authors of this response all have high volume bariatric surgery practices encompassing experience with both gastric bypass and gastric banding, and have made significant contributions to the peer reviewed literature. We examined the assumptions of the paper, reviewed the main articles cited, provided more evidence from articles that were included in the materials and methods of the paper, but not cited, and challenge the conclusion that Roux-en-Y gastric bypass is superior to gastric banding. RESULTS AND DISCUSSION: The paper by Guller et al was subject to significant bias. The authors did not demonstrate an understanding of gastric banding, selectively included data with unfavorable results towards gastric banding, did not provide equal critique to the literature on gastric bypass, and deliberately excluded much of the favorable data on gastric banding. CONCLUSION: The paper's conclusion that gastric bypass is the procedure of choice is biased, unsubstantiated, not supported by the current literature and represents a disservice to the scientific and health care community.

Laparoscopic adjustable gastric banding in an ambulatory surgery center.

BACKGROUND: In the management of morbid obesity by laparoscopic adjustable gastric banding (LAGB), careful patient preparation and attentive follow-up have been shown to produce the best long-term results. METHODS: Between November 2002 and August 2007, prospective data were collected on 2,411 consecutive patients, 84% of whom underwent LAGB at our freestanding outpatient surgery center, staffed by our dedicated multidisciplinary bariatric team. Outcomes reported include changes in mean body mass index (BMI), percentage excess body weight loss (%EBWL), and incidence of complications at 1 year, as well as the slippage rate up to 3 years. RESULTS: A total of 2,003 (83%) female and 409 (17%) male patients with a mean age of 44.1 years (range 15-76 yrs) and a BMI (mean +/- SD) of 45.7 +/- 7.9 kg/m2 (range 29.1-83.1 kg/m2) underwent LAGB. In 2,027 patients (84%), LAGB was performed as an outpatient procedure, with 1 (0.04%), conversion from a laparoscopic to an open procedure. The majority of operations were completed in less than 1 hour, using the pars flaccida technique. One-year weight loss data were available in 1,144 patients (47%). BMI decreased to 36.9 +/- 7.4 kg/m2 (-8.8). Mean %EBWL at 1 year (+/- 60 days) was 41.0% +/- 18.1% (range 0.7%-113.9%). Complications occurred in 241 of 2,411 (10%) patients. There was 1 death (0.04%). Cumulative slippage at 1, 2, and 3 years, respectively, was 0.4%, 2.4%, and 10%. There were 56 (2.3%) port-related problems, and 13 band explantations (0.54%). CONCLUSIONS: With extensive staff experience and patient preparation, LAGB can be performed safely as an outpatient procedure for select patients. Close follow-up is crucial in order to optimize LAGB outcomes for the long term.

Outpatient laparoscopic adjustable gastric banding in super-obese patients.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) is a safe and effective treatment for morbid obesity that is well suited to outpatient surgery. Super-obese patients (BMI > or = 50) are often viewed as higher risk patients, with their surgical procedures limited to hospital operating-rooms. We report our experience performing LAGB for super-obese patients in a freestanding ambulatory surgery center and describe the program elements that make this feasible and safe. METHODS: Database records containing 1,780 consecutive patients from program inception (November 2002 to November 2006) were searched for patients with a BMI >49.9 undergoing an outpatient LAGB and reviewed to identify complications. RESULTS: 320 super-obese patients underwent an outpatient LAGB. Mean preoperative weight was 155.2 kg (range 112.3-220.5 kg), and mean BMI was 55.4 kg/m2 (range 50.0-71.1 kg/m2). 53 patients (16.6%) had BMI >60. There were no deaths, significant cardiopulmonary complications, significant intraoperative bleeding, conversion to open laparotomy, or hospital admissions. 3 patients (0.1%) developed gastric edema causing transient obstruction, and 1 developed a delayed colon perforation from electrocautery incurred during adhesiolysis. No complication arose or was more difficult to manage as a result of the procedure being done on an outpatient basis. CONCLUSIONS: Outpatient LAGB can be safely performed in super-obese patients with a complication rate similar to lower BMI patients. Patient selection and preoperative preparation are essential to achieve excellent outcomes. The decision to offer an outpatient LAGB should rest on the overall physiological condition rather than BMI or weight alone.

Adjustable gastric banding in an ambulatory surgery center.

BACKGROUND: We report our early experience with 343 consecutive patients who underwent laparoscopic adjustable gastric banding (LAGB) as an outpatient procedure in a self-standing ambulatory surgery center. METHODS: Between Apr 2003 and Feb 2005, data was collected prospectively on 343 consecutive patients who underwent LAGB as an outpatient. RESULTS: There were 305 females (88.9%) and 38 males (11.1%), with mean age 43.5 years (+/-SD 9.9, range 19-67) and mean BMI 44.5 kg/m2 (+/-SD 6.1, range 32.7-62.7). Mean operating-room time was 52.9 (+/-16.3) minutes. 10 complications occurred in 9 patients (2.8%): 5 stoma occlusion, 3 port problems requiring port replacement, 1 superficial wound infection, and 1 colon perforation associated with adhesiolysis requiring band removal. 3 patients required admission to the hospital: 1 for nausea, 1 for observation after bloody nasogastric tube drainage, and 1 for dysphagia due to esophageal spasm. All 9 patients with complications recovered fully. 1-year weight loss data was available in 91 patients; mean percent excess weight lost (%EWL) at 1 year was 45.4% (+/-17.6). CONCLUSIONS: LAGB has become an appropriate outpatient procedure in select patients.

Laparoscopic adjustable gastric banding: weight loss, co-morbidities, medication usage and quality of life at one year.

BACKGROUND: The objective of this study was to determine the weight loss, changes in co-morbidities, medication usage and general health status at 1 year after laparoscopic adjustable gastric banding (LAGB). METHODS: Prospective data were obtained from all subjects undergoing LAGB. These measurements included a medical history and review of systems, medications, height and weight and the SF-36 general health survey. Patients were seen for band adjustments as needed throughout the year. At the 1-year follow-up visit, patients were weighed and interviewed about the status of their health conditions and their current medications, and the SF-36 was repeated. RESULTS: Between November 2002 and November 2003, 195 patients had LAGB. The majority of subjects were female (82.8%), married (65.1%), and white (94.9%). Complications occurred in 18 subjects (9.2%). These included 3 slipped bands (1.5%), 4 port problems (2.1%), 8 patients with temporary stoma occlusion (4.1%), 1 explantation (0.5%), and 1 mortality (0.5%). Mean BMI decreased from 45.8 kg/m2 (+/- 7.7) to 32.3 kg/m2 (+/- 7.0). Mean percent excess body weight lost was 45.7% (+/- 17.1) during the first year. Major improvements occurred in arthritis, asthma, depression, diabetes, gastro-esophageal reflux disease, hyperlipidemia, hypertension, joint and back pain, sleep apnea and stress incontinence. Medication usage declined remarkably. Quality of life (QoL) by the SF-36 showed highly significant improvements. CONCLUSIONS: At 1 year after LAGB, patients had experienced significant weight loss, resolution of comorbidities, decreases in medication usage, and improvements in QoL.

Laparoscopic adjustable gastric banding: early experience in 400 consecutive patients in the USA.

BACKGROUND: Early experience with 400 consecutive patients who underwent laparoscopic adjustable gastric banding (LAGB) is reported. METHODS: From Nov 2002 to Aug 2004, prospective data were collected on 400 consecutive LAGB patients and evaluated retrospectively. RESULTS: There were 354 (88.5%) females and 46 males (11.5%), with mean age 43.6 years and mean BMI 46.2 kg/m2. For outpatients (freestanding ambulatory surgery center), mean OR time was 55.4 min in 208 patients (52%), compared to mean inpatient OR time of 70.5 min in 192 patients. Inpatients had a higher BMI (48.2 +/- 9.3 SD) than outpatients (43.9 +/- 5.7 SD) (P<0.0001). Complications occurred in 35 patients (8.8%). These consisted of 9 slipped bands (2.3%) that were surgically repositioned, 6 port problems (1.5%) that were successfully repaired, 17 patients with temporary stoma occlusion (4.3%) that spontaneously resolved, and 2 bowel perforations (0.5%) that required surgical repair and band removal. One patient died of pneumonia 2 weeks after an uneventful procedure. Average 1-year percent excess weight loss (%EWL) in 138 patients was 48.2%. Patients who had < or =50 kg initial excess weight (n=37, 27%) had a significantly higher %EWL (55.2%) at 1 year than patients who had >50 kg initial excess weight (P=0.0011). CONCLUSIONS: LAGB has been safe and effective thus far for the surgical treatment of morbid obesity, and can be performed as an outpatient in select patients.