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However, the baseline and demographic characteristics of the randomized, enrolled, and completer populations were analyzed for homogeneity and were not different in the AspireAssist and Lifestyle Counseling groups. The data were collected and analyzed pre- and post-operatively. S8 Note - This prescription item is Schedule 8 and can only be supplied on a script from a registered doctor in Queensland. Sufficient implant training is required, but problems can still occur e. A fatty liver is heavy, brittle, and more likely to suffer injury during surgery. It offered insight into an early time course for symptom resolution, and explored the impact of weight-loss surgery on migraine headaches.
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Restless legs syndrome Unwanted urge to move. COPD When it's hard to breathe. How to outsmart salt at the grocery store. Subscribe Now Subscribe today and get access to special reports instantly! A total of 71 patients underwent sclerotherapy at their gastrojejunostomy from July to August A retrospective review was performed of this group, including chart review, follow-up data with weight checks, and telephone interview findings.
The average age of the patients was 45 years and all but 4 patients were women. Sclerotherapy was done an average of 2. The starting weight at endoscopy was an average of lb lb heavier than the average nadir weight. The average diameter of the gastrojejunostomy was 2. An average of 13 mL morrhuate sodium was injected circumferentially.
No hospital admissions or complications occurred in relation to the procedure. The analysis showed a high body mass index at endoscopy to be the only predictive factor for successful weight maintenance or loss. In a article, Spaulding, Osler and Patlak studied endoscopic sclerotherapy with sodium morrhuate of a dilated gastrojejunostomy in gastric bypass patients.
Their weight trends before and after treatment were assessed by paired t test. A total of 32 patients who were gaining weight after gastric bypass underwent sclerotherapy of their dilated gastrojejunostomy.
The timing of treatment ranged from 10 to months average 56 after Roux-en-Y gastric bypass. Before sclerotherapy, patients were gaining weight at a rate of.
After treatment, they were losing weight at a rate of. Endoscopic duodenal-jejunal bypass is the endoscopic placement of a duodenal-jejunal bypass sleeve eg, EndoBarrier which lines the first section of the small intestine causing food to be absorbed further along the intestine.
Once implanted, the device is purported to influence gastrointestinal hormones and satiety. It is suggested to promote weight loss in individuals who are potential candidates for bariatric surgery, but are too heavy to safely undergo the procedure.
An UpToDate review on " Bariatric surgical operations for the management of severe obesity: The EndoBarrier is cm long and it extends from the proximal duodenum to the mid-jejunum and thus mimics a duodenojejunal bypass.
The ValenTx is a cm barrier device that extends from the gastroesophageal junction to the jejunum. The EndoBarrier, an endoscopically delivered duodeno-jejunal bypass liner DJBL , is a plastic flexible tube that is placed in the duodenal bulb, directly behind the pylorus.
It extends from the duodenum to the proximal jejunum. Recent studies have suggested that the use of EndoBarrier has resulted in significant weight reduction in comparison to control-diet patients. Schouten et al noted that the endoscopically placed duodenal-jejunal bypass sleeve or EndoBarrier Gastrointestinal Liner has been designed to achieve weight loss in morbidly obese patients.
These researchers reported on the first European experience with this device. A multi-center, randomized clinical trial was performed. A total of 41 patients were included and 30 underwent sleeve implantation; 11 patients served as a diet control group. All patients followed the same low-calorie diet during the study period. The purpose of the study was to determine the safety and effectiveness of the device. A total of 26 devices were successfully implanted. In 4 patients, implantation could not be achieved.
The remaining patients all completed the study. Mean procedure time was 35 mins range of 12 to for a successful implantation and 17 mins range of 5 to 99 for explantation. There were no procedure related adverse events. Initial mean BMI was Mean excess weight loss after 3 months was Absolute change in BMI at 3 months was 5.
Type 2 diabetes mellitus was present at baseline in 8 patients of the device group and improved in 7 patients during the study period lower glucose levels, HbA1c, and medication requirements. The authors concluded that the EndoBarrier Gastrointestinal Liner is a feasible and safe non-invasive device with excellent short-term weight loss results.
The device also has a significant positive effect on type 2 diabetes mellitus. Moreover, they stated that long-term randomized and sham studies for weight loss and treatment of diabetes are necessary to determine the role of the device in the treatment of morbid obesity.
Escalona et al evaluated safety, weight loss, and cardio-metabolic changes in obese subjects implanted with the DJBL for 1 year. Morbidly obese subjects were enrolled in a single-arm, open-label, prospective trial and implanted with the DJBL.
Primary endpoints included safety and weight change from baseline to week Secondary endpoints included changes in waist circumference, blood pressure, lipids, glycemic control, and metabolic syndrome. Three subjects could not be implanted due to short duodenal bulb. There were no procedure-related complications and there were 15 early endoscopic removals. In the week completer population, total body weight change from baseline was There were also significant improvements in waist circumference, blood pressure, total and low-density lipoprotein cholesterol, triglycerides, and fasting glucose.
The authors concluded that the DJBL is safe when implanted for 1 year, and results in significant weight loss and improvements in cardio-metabolic risk factors. They stated that these results suggested that this device may be suitable for the treatment of morbid obesity and its related comorbidities.
Verdam et al stated that the prevalence of obesity is increasing worldwide. Its primary treatment consists of lifestyle changes.
Operations such as the placement of a gastric band or a gastric bypass can, however, lead to complications and necessitate secondary interventions. In search of less invasive treatments, placement of the EndoBarrier duodenal jejunal bypass liner appears to be a promising, safe and effective method for facilitating weight loss. Concomitant positive effects on cardiovascular risk factors including diabetes type 2 were observed.
The authors noted that a multi-center trial is currently underway to examine the mechanism behind these effects. Mathus-Vliegen stated that the EndoBarrier is a unique concept that starts to ameliorate the symptoms of diabetes mellitus type 2, soon after positioning.
Sufficient implant training is required, but problems can still occur e. The stability of the anchors and the tolerability of the device still leave much to be desired. Only 7 studies on the EndoBarrier are available and these are mostly small in size, short-term and with limited follow-up, and many questions regarding the safety and long-term effects of the device remain. The author concluded that this calls for a large, long-term, randomized, placebo-controlled, double-blind trial.
Lessons should have been learned from the disastrous results with intra-gastric balloon implantation before commercializing another such product. Bolton et al stated that weight regain secondary to VBG pouch dilation is a typical referral for bariatric surgeons. A retrospective review was completed for patients with a previous VBG presenting with weight regain between to Complications following RYGB include: The median length of stay following RYGB was 6 days compared to 1.
The authors concluded that the findings of this study suggested that while RYGB revision may achieve greater weight loss, the complication rates and severity is discouraging. StomaphyX may be a safe alternative. Moreover, they stated that further technical modifications of the device and longer follow-up may clarify the role of this approach. Goyal et al examined if endoluminal reduction of gastric pouch and stoma using StomaphyX results in sustained weight loss in patients who regain weight after gastric bypass.
Retrospective chart review was performed on 59 post-gastric bypass patients who underwent revision of gastric pouch using StomaphyX from to Post-procedure weight at 1 week, 1 month, and 6 months follow-up as well as weight at the time of the review was recorded for each patient.
Average weight loss and excess body weight loss EBWL were 2. At the time of review, the average follow-up was 41 months, average weight loss was 1. Endoscopy in 12 patients at average 18 months follow-up showed no sustained reduction in pouch and stoma size. The authors concluded that StomaphyX resulted in weight loss that is not sustained on long-term follow-up. Pouch and stoma tend to regain their pre-procedure size on follow-up.
They stated that StomaphyX cannot be recommended as a weight loss strategy in post-gastric bypass patients who regain weight. There is currently no well-defined management protocol for this complication.
Through systematic review, these investigators analyzed the results of endoscopic dilation in patients with stenosis, including complication and success rates. The PubMed database was searched for relevant studies published each year from to , and 23 studies were identified for analysis.
Only papers describing the treatment of anastomotic stricture after RYGB were included, and case-reports featuring less than 3 patients were excluded. The mean age of the trial populations was Through-the-scope balloons were used in 16 studies Other complications were also reported: The authors concluded that endoscopic treatment of stenosis is safe and effective; however, further high-quality randomized controlled trials are needed to confirm these findings.
Thompson et al stated that weight regain or insufficient loss after RYGB is common. This is partially attributable to dilatation of the gastro-jejunostomy, which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. These researchers performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction TORe. Intra-operative performance, safety, weight loss, and clinical outcomes were assessed.
Subjects who received TORe had a significantly greater mean percentage weight loss from baseline 3. As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls 3. The groups had similar frequencies of adverse events. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices. These researchers stated that TORe is one approach to avoid weight regain; moreover, they noted that a longitudinal multi-disciplinary approach with dietary counseling and behavioral changes are needed for long-term results.
Jirapinyo et al evaluated the technical feasibility, safety, and early outcomes of a procedure using a commercially available endoscopic suturing device to reduce the diameter of the GJA. An endoscopic suturing device was used to place sutures at the margin of the GJA in order to reduce its aperture. On chart review, clinical data were available at 3, 6, and 12 months. Average anastomosis diameter was The mean weight loss in successful cases was There were no major complications.
The authors concluded that this case series demonstrated the technical feasibility, safety, and effectiveness of performing GJ reduction using a commercially available endoscopic suturing device.
They stated that this technique may represent an effective and minimally invasive option for the management of weight regain in patients with RYGB. Dakin and colleagues noted that weight recidivism after RYGB is a challenging problem for patients and bariatric surgeons alike. Traditional operative strategies to combat weight regain are technically challenging and associated with a high morbidity rate.
Endoluminal interventions are thus an attractive alternative that may offer a good combination of results coupled with lower peri-procedure risk that might one day provide a solution to this increasingly prevalent problem.
These investigators systematically reviewed the available literature on endoluminal procedures used to address weight regain after RYGB, with specific attention to the safety profile, effectiveness, cost, and current availability. This retrospective review focused only on endoluminal procedures that were performed for weight regain after RYGB, as opposed to primary endoluminal obesity procedures.
Several methods of endoluminal intervention for weight regain were reviewed, ranging from injection of inert substances to suturing and clipping devices. The literature review showed the procedures on the whole to be well-tolerated with limited effectiveness. The majority of the literature was limited to small case-series. Most of the reviewed devices were no longer commercially available. The authors concluded that endoluminal therapy represents an intriguing strategy for weight regain after RYGB.
However, the current and future technologies must be rigorously studied and improved such that they offer durable, repeatable, cost-effective solutions. Pauli et al stated that despite advances in many areas of therapeutic endoscopy, the development of an effective endoscopic suturing device has been elusive. These researchers evaluated the safety and effectiveness of a suturing device to place and secure sutures within normal, in-vivo human colonic tissue prior to surgical resection.
Patients undergoing elective colectomy were enrolled in this treat-and-resect model. The OverStitch endoscopic suturing device Apollo Endosurgery, Austin, TX was used to place sutures in healthy colonic tissue during a min, time-limited period. Clinical and operative data were recorded. Seven sutures were successfully placed, incorporating a total of 10 tissue bites in a mean of On inspection of the explanted tissue, all sutures were found to be located sub-serosal no full thickness bites were taken.
The suture and cinch elements were judged to be effective in the majority of cases. One device-related issue did not inhibit the ability to oppose tissue or place the cinch. There were no intra-operative or post-operative complications. The authors concluded that the OverStitch permitted safe and effective suturing in an in-vivo human colon model. The sutures were placed at a consistent sub-serosal depth and at no point risked iatrogenic injury to adjacent structures.
Technical issues with the device were infrequent and did not inhibit the ability to place sutures effectively. This clinical trial is designed to study the Apollo OverStitch endoscopic suturing device that has already been approved by the FDA as an option for bariatric surgery revision without having to re-operate on the patient.
The investigators believe that the endoscopic technique may be able to provide weight loss without having to re-operate on the patient. A total of 22 obese patients mean age of After dissecting the greater omentum and short gastric vessels, the gastric greater curvature plication with 2 rows of non-absorbable suture was performed under the guidance of a F bougie. The data were collected during follow-up examinations performed at 1, 3, 6, and 12 months post-operatively.
All procedures were performed laparoscopically. The mean operative time was There were no deaths or post-operative major complications that needed re-operation. Decreases in the index for homeostasis model assessment of insulin resistance HOMA-IR and in insulin and glucose concentrations were observed. The authors concluded that the early outcomes of LGCP as a novel treatment for obese Chinese with a relatively low BMI were satisfactory with respect to the effectiveness and low incidence of major complications.
They stated that additional long-term follow-up and prospective, comparative trials are still needed. In a pilot study, Legner et al examined the effectiveness of transoral mucosal excision sutured gastroplasty for the treatment of gastro-esophageal reflux disease GERD and obesity.
Obese patients BMI greater than 35 underwent a psychological evaluation and tests for co-morbidities. Under general anesthesia, a procedure was performed at the gastro-esophageal junction including mucosal excision, suturing of the excision beds for apposition, and suture knotting.
One patient with micrognathia could not undergo the required pre-procedural passage of a 60 F dilator and was excluded. The first 2 GERD patients had incomplete procedures due to instrument malfunction. The subsequent 5 subjects had a successfully completed procedure. Four patients were treated for obesity and had an average excess weight loss of Of these patients, 1 had an 8-mm outlet at the end of the procedure recognized on video review -- a correctable error -- and another vomited multiple times post-operatively and loosened the gastroplasty sutures.
The treated GERD patient had resolution of reflux-related symptoms and is off all anti-secretory medications at 2-year follow-up. Her DeMeester score was 8. The authors concluded that the initial human clinical experience showed promising results for effective and safe GERD and obesity therapy. Georgiadou et al summarized the available evidence about the efficacy and safety of laparoscopic mini-gastric bypass LMGB.
These investigators performed a systematic search in the literature, and PubMed and reference lists were scrutinized end-of-search date: For the assessment of the eligible articles, the Newcastle-Ottawa quality assessment scale was used.
A total of 10 eligible studies were included in this study, reporting data on 4, patients. Moreover, resolution or improvement in all major associated medical illnesses and improvement in overall Gastrointestinal Quality of Life Index score were recorded.
Major bleeding and anastomotic ulcer were the most commonly reported complications. The latter were conducted due to a variety of medical reasons such as inadequate or excessive weight loss, malnutrition, and upper gastro-intestinal bleeding. The authors concluded that LMGB represents an effective bariatric procedure; its safety and minimal post-operative morbidity seem remarkable.
They stated that randomized comparative studies seem mandatory for the further evaluation of LMGB. These researchers included 10 studies with a total of patients that primarily investigated a prototype of the DJBL. In high-grade obese patients, short-term excess weight loss was observed.
For the remaining patient-relevant endpoints and patient populations, evidence was either not available or ambiguous. The authors do not yet recommend the device for routine use. Parikh et al compared bariatric surgery versus intensive medical weight management MWM in patients with type 2 diabetes mellitus T2DM who do not meet current National Institutes of Health criteria for bariatric surgery and examined if the soluble form of receptor for advanced glycation end products sRAGE is a biomarker to identify patients most likely to benefit from surgery.
A total of 57 patients with T2DM and BMI 30 to 35, who otherwise met the criteria for bariatric surgery were randomized to MWM versus surgery bypass, sleeve or band, based on patient preference. The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance HOMA-IR and diabetes remission.
The surgery group lost more weight 7. There were no mortalities. Baseline sRAGE may predict patients most likely to benefit from surgery. However, they stated that these findings need to be confirmed with larger studies. Sjostrom et al noted that short-term studies showed that bariatric surgery causes remission of diabetes. The long-term outcomes for remission and diabetes-related complications are not known. These researchers determined the long-term diabetes remission rates and the cumulative incidence of microvascular and macrovascular diabetes complications after bariatric surgery.
The Swedish Obese Subjects SOS is a prospective matched cohort study conducted at 25 surgical departments and primary health care centers in Sweden. Of patients recruited between September 1, , and January 31, , of 2, control patients and of 2, surgery patients had type-2 diabetes at baseline. For the current analysis, diabetes status was determined at SOS health examinations until May 22, Information on diabetes complications was obtained from national health registers until December 31, For diabetes assessment, the median follow-up time was 10 years interquartile range [IQR], 2 to 15 and 10 years IQR, 10 to 15 in the control and surgery groups, respectively.
For diabetes complications, the median follow-up time was Main outcome measures were diabetes remission, relapse, and diabetes complications. The diabetes remission rate 2 years after surgery was At 15 years, the diabetes remission rates decreased to 6. With long-term follow-up, the cumulative incidence of microvascular complications was Macrovascular complications were observed in The authors concluded that in this very long-term follow-up observational study of obese patients with type 2 diabetes, bariatric surgery was associated with more frequent diabetes remission and fewer complications than usual care.
Moreover, they stated that these findings require confirmation in randomized trials. Yu et al evaluated the long-term effects of bariatric surgery on type 2 diabetic patients. Randomized controlled trials RCTs and cohort studies of bariatric surgery for diabetes patients that reported data with more than 2 years of follow-up were included. They used rigorous methods to screen studies for eligibility and collected data using standardized forms.
Where applicable, these investigators pooled data by meta-analyses. A total of 26 studies, including 2 RCTs and 24 cohort studies that enrolled 7, patients, proved eligible. Despite the differences in the design, those studies consistently showed that bariatric surgery offered better treatment outcomes than non-surgical options. Pooling of cohort studies showed that BMI decreased by Diabetes was improved or in remission in The authors noted that bariatric surgery may achieve sustained weight loss, glucose control, and diabetes remission.
Moreover, they stated that large randomized trials with long-term follow-up are warranted to demonstrate the effect on outcomes important to patients e.
There are a growing number of unblinded trials comparing bariatric surgery with medical therapy for the treatment of type 2 diabetes …. Despite these impressive metabolic results, concerns remain about acute post-operative complications including need for re-operations and re-hospitalizations and rare, but potentially severe, adverse events; the long-term success rates in maintaining weight loss; and the reproducibility of the results in patients with an extensive history of diabetes or with a different surgical team.
Some weight regain is typical within two to three years of bariatric procedures, and different bariatric procedures result in different levels of weight loss and corresponding reductions in glycemia. The electrical impulses are purported to block vagus nerve signals in the abdominal region, inhibiting gastric motility and increasing satiety. However, there is currently insufficient evidence to support the VBLOC vagal nerve blocking therapy for the treatment of obesity.
In an open-label, 3-center study, Camilleri et al evaluated the effects of vagal blocking VBLOC therapy on excess weight loss EWL , safety, dietary intake, and vagal function. Electrodes were implanted laparoscopically on both vagi near the esophago-gastric junction to provide electrical block. Patients were followed for 6 months for body weight, safety, electrocardiogram, dietary intake, satiation, satiety, and plasma pancreatic polypeptide PP response to sham feeding.
To specifically assess device effects alone, no diet or exercise programs were instituted. A total of 31 patients mean BMI of Mean EWL at 4 and 12 weeks and 6 months after implant was 7. There were no deaths or device-related serious adverse events AEs. Three patients had serious AEs that required brief hospitalization, 1 each for lower respiratory tract, subcutaneous implant site seroma, and Clostridium difficile diarrhea.
The authors concluded that intermittent, intra-abdominal vagal blocking is associated with significant EWL and a desirable safety profile. A total of subjects were enrolled at 15 centers. Devices in both groups performed regular, low-energy safety checks. The authors concluded that VBLOC therapy to treat morbid obesity was safe, but weight loss was not greater in treated compared to controls; clinically important weight loss, however, was related to hours of device use.
Post-study analysis suggested that the system electrical safety checks low charge delivered via the system for electrical impedance, safety, and diagnostic checks may have contributed to weight loss in the control group. In an open-label study, Shikora et al evaluated the effect of intermittent vagal blocking VBLOC on weight loss, glycemic control, and blood pressure BP in obese subjects with diabetes mellitus type-2 DM2.
One serious AE pain at implant site was easily resolved. The authors stated that additional long-term data and continued follow-up of the ReCharge study are needed to further characterize the safety and effectiveness profile of vBloc therapy. Natural orifice transluminal endoscopic surgery NOTES is being explored for a variety of surgeries, including bariatric procedures.
NOTES procedures are incisionless surgeries performed with an endoscope passed through the mouth. Tissue approximation and closure devices are being developed for use in conjunction with various endoscopic procedures, including NOTES. Restorative obesity surgery, endoluminal ROSE procedure is suggested for the treatment of weight regain following gastric bypass surgery due to a gradual expansion of the gastric pouch. The stomach is accessed orally via an endoscope and reduced in size using an endoscopic closure device.
Transoral gastroplasty TG , also referred to as vertical sutured gastroplasty or endoluminal vertical gastroplasty, is an incisionless procedure in which the stomach is purportedly restricted with staples or sutures by using endoscopic surgical tools guided through the mouth and esophagus. Main outcome measure was technical feasibility. These researchers successfully used an endoscopic free-hand suturing system in 4 subjects, thus demonstrating the technical feasibility of a novel technique to mimic the anatomic manipulations created by surgical sleeve gastrectomy endoscopically.
The authors concluded that endoscopic sleeve gastroplasty ESG for treatment of obesity is feasible. The main drawback of this study was that it was a pilot feasibility study with small number of subjects. Sharaiha et al stated that novel endoscopic techniques have been developed as effective treatments for obesity.
Recently, reduction of gastric volume via endoscopic placement of full-thickness sutures, termed ESG, has been described. These investigators evaluated the safety, technical feasibility, and clinical outcomes for ESG. Between August and May , ESG was performed on 10 patients using an endoscopic suturing device. Their weight loss, waist circumference, and clinical outcomes were assessed.
Mean patient age was There were no significant adverse events noted. The differences observed in mean BMI and waist circumference were 4. The authors concluded that ESG is effective in achieving weight loss with minimal adverse events.
They stated that this approach may provide a cost-effective out-patient procedure to add to the steadily growing armamentarium available for treatment of this significant epidemic.
Lopez-Nava et al described the ESG used in 50 patients. The goal of this procedure is to reduce the gastric lumen into a tubular configuration, with the greater curvature modified by a line of sutured plications. General anesthesia with endotracheal intubation is needed. An endoscopic suturing system requiring a specific double-channel endoscope delivers full-thickness sets of running sutures from the antrum to the fundus. Patients were admitted and observed, with discharge planned within 24 hours.
Post-procedure out-patient care included diet instruction with intensive follow-up by a multi-disciplinary team. Voluntary oral contrast and endoscopy studies were scheduled to evaluate the gastroplasty at 3, 6, and 12 months.
The technique was applied in 50 patients 13 men with an average BMI of Procedure duration averaged 66 mins during which 6 to 8 sutures on average were placed. All patients were discharged in less than 24 hours. There were no major intra-procedural, early, or delayed adverse events. Weight loss parameters were satisfactory, mean BMI changes from Oral contrast studies and endoscopy revealed sleeve gastroplasty configuration at least until 1 year of follow-up.
The authors concluded that ESG is a safe, effective, and reproducible primary weight loss technique. Furthermore, a Cochrane review on "Surgery for weight loss in adults" Colquitt et al, as well as an UpToDate review on " Bariatric surgical operations for the management of severe obesity: Descriptions " Lim, do not mention endoscopic sleeve gastroplasty as a therapeutic option.
In a pilot study, Sullivan and colleagues evaluated the use of endoscopic aspiration therapy for the treatment of obesity. This method entails endoscopic placement of a gastrostomy tube A-Tube and the AspireAssist siphon assembly Aspire Bariatrics, King of Prussia, PA to aspirate gastric contents 20 minutes after meal consumption.
These researchers performed a study of 18 obese subjects who were randomly assigned 2: Lifestyle intervention comprised a session diet and behavioral education program; 10 of the 11 subjects who underwent aspiration therapy and 4 of the 7 subjects who underwent lifestyle therapy completed the 1st year of the study.
After 1 year, subjects in the aspiration therapy group lost There were no AEs of aspiration therapy on eating behavior and no evidence of compensation for aspirated calories with increased food intake. No episodes of binge eating in the aspiration therapy group or serious AEs were reported. The authors concluded that aspiration therapy appeared to be a safe and effective long-term weight loss therapy for obesity.
These preliminary findings from a pilot study need to be validated by well-designed studies. Forssell and Noren evaluated the effectiveness of a novel device, the AspireAssist aspiration therapy system, for the treatment of obesity. After 4 weeks taking a very-low-calorie diet, 25 obese men and women BMI A low-profile valve was installed 14 days later and aspiration of gastric contents was performed approximately 20 minutes after meals 3 times per day.
Cognitive behavioral therapy was also started. At month 6, mean weight lost was The mean percentage EWL was No clinically significant changes in serum potassium or other electrolytes occurred.
The authors concluded that in this study, substantial weight loss was achieved with few complications using the AspireAssist system, suggesting its potential as an attractive therapeutic device for obese patients.
A total of 25 obese subjects, mean age of 48 years range of 33 to 65 were included in this study. A custom gastrostomy tube A-tube was percutaneously inserted during a gastroscopy performed under conscious sedation.
Drainage and irrigation of the stomach were performed 3 times daily, 20 mins after each meal, for 1 to 2 years. Efficient aspiration required thorough chewing of ingested food.
Treatment included a cognitive behavioral weight loss program. Mean BMI at inclusion was Quality of life, as measured with EQ-5D, improved from 0. After 2 years BMI was There were no serious AEs or electrolyte disorders. The authors concluded that aspiration therapy is a safe and efficient treatment for obesity, and weight reduction improves quality of life.
Excess weight was approximately halved in a year, with weight stability if treatment was continued; and long-term results remain to be investigated. It is unclear whether firm conclusions can be drawn from a person observational study.
This study only encompasses treatment during 1 to 2 years. Long-term patency is still unknown. It is our belief that once the desired weight goal is achieved many, if not most, patients will need to continue aspiration therapy, albeit possibly at a reduced frequency, to maintain weight stability. In this week clinical trial, a total of subjects with a BMI of A total of The most frequently reported AEs were abdominal pain and discomfort in the peri-operative period and peristomal granulation tissue and peristomal irritation in the post-operative period.
Serious AEs were reported in 3. On June 14, , the FDA approved the AspireAssist device to assist in weight loss in patients aged 22 and older who are obese, with a BMI of 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy.
Side effects related to use of the AspireAssist include occasional indigestion, nausea, vomiting, constipation and diarrhea. The AspireAssist is contraindicated in those with certain conditions, including uncontrolled hypertension, diagnosed bulimia, diagnosed binge eating disorder, night eating syndrome, certain types of previous abdominal surgery, pregnancy or lactation, inflammatory bowel disease or stomach ulcers.
The AspireAssist is also contraindicated in patients with a history of serious pulmonary or cardiovascular disease, coagulation disorders, chronic abdominal pain or those at a high-risk of medical complications from an endoscopic procedure.
Furthermore, the AspireAssist device it is not indicated for use in short durations in those who are moderately overweight. In a post-market study, Nystrom and colleagues evaluated long-term safety and efficacy of aspiration therapy AT in a clinical setting in 5 European clinics. A total of participants, with BMI of Mean baseline BMI was Mean percent total weight loss at 1, 2, 3, and 4 years, respectively, was Clinically significant reductions in glycated hemoglobin HbA1C , triglycerides, and blood pressure were observed.
The authors concluded that the findings of this study established that AT is a safe, effective, and durable weight loss therapy in people with classes II and III obesity in a clinical setting. Kumar and associates noted that weight management is increasingly incorporating endoscopic bariatric therapy EBT.
As the global burden of obesity and its co-morbidities has increased, it is evident that novel therapeutic approaches will be necessary to address the obesity epidemic. EBTs offer greater efficacy than diet and lifestyle modification and lower invasiveness than bariatric surgery. The FDA has approved 2 intra-gastric balloons and aspiration therapy AT for the treatment of obesity: These devices have proven safe and effective in clinical trials and are gaining commercial acceptance in the USA; the Orbera has been used extensively outside the USA for over 20 years.
These devices will need to be delivered in the context of a multi-disciplinary weight loss program, integrating comprehensive care of obesity. Patient selection is important, and ensuring appropriate patient expectations and understanding of alternatives such as pharmacologic therapy and surgery is essential.
With several EBTs on the horizon, patients with obesity will have an even broader array of safe and effective options for weight management in the future.
The authors stated that AT addresses a broader BMI range and offers the potential for a significant and durable weight loss. Pajot and co-workers stated that EBT is a rapidly developing area that has now seen FDA approval of 6 endoscopic bariatric devices and procedures and there are a number of other novel EBTs progressing through various stages of development with newly published findings.
This paper aimed to assist readers in either selecting an appropriate therapy for their patient or deciding to incorporate these therapies into their practice. This paper provided an updated review of the available data on EBTs, both FDA approved and not, with a particular focus on safety and effectiveness, as well as guidance for discussing with patients the decision to use endoscopic therapies.
The authors of a large meta-analysis of Orbera concluded its ideal balloon volume to be to ml. AspireAssist has had favorable effectiveness and safety data published in a large RCT.
A large study of endoscopic sleeve gastroplasty has published findings at up to 24 months showing promising durability. Elipse, a swallowed intra-gastric balloon not requiring endoscopy for either insertion or removal, has had early favorable results published. A magnet-based system for creation of a gastrojejunostomy has published favorable findings from its pilot study. The authors concluded that EBTs are safe and effective therapies for weight loss when used in conjunction with lifestyle changes and fill an important gap in the management of obesity.
These researchers stated that more study is needed to understand the role of EBTs used in combination or in sequence with medications and bariatric surgery. Christensen and colleagues noted that AT with AspireAssist is a novel endoscopic obesity treatment.
AspireAssist was recently approved by the FDA, and it induced weight loss comparable to the weight loss observed after bariatric surgery, but with a lower risk of complications.
The authors stated that few clinical studies about the safety and efficacy of AspireAssist have been carried out and published. Thus, further intervention studies evaluating acute as well as long-term effects are needed. Smith et al examined if bariatric surgery prior to total hip arthroplasty THA or total knee arthroplasty TKA reduces the complication rates and improves the outcome following arthroplasty in obese patients.
These researchers performed a systematic literature search of published and unpublished databases on the November 5, All papers reporting studies comparing obese patients who had undergone bariatric surgery prior to arthroplasty, or not, were included. E ach study was assessed using the Downs and Black appraisal tool. From potential studies, 5 were considered to be eligible for inclusion in the study. A total of 23, patients who had undergone bariatric surgery, 22, who had not were analyzed.
The evidence-base was moderate in quality. There was no statistically significant difference in outcomes such as superficial wound infection RR 1. The authors concluded that for most peri-operative outcomes, bariatric surgery prior to THA or TKA did not significantly reduce the complication rates or improve the clinical outcome. They stated that the findings of this study questions the previous belief that bariatric surgery prior to arthroplasty may improve the clinical outcomes for patients who are obese or morbidly obese.
This finding is based on moderate quality evidence. Abdemur et al stated that laparoscopic sleeve gastrectomy LSG as a primary bariatric procedure has gained significant popularity. Between January and August , a total of 1, patients underwent primary LSG for morbid obesity.
Of the entire cohort of revisions, 9 0. Both the stricture and the leak patients were referred from outside institutions. The authors concluded that the most common reason for conversion was chronic leak. El Chaar et al noted that bariatric surgery is the only proven and effective long-term treatment for morbid obesity, with LSG being the most commonly performed weight loss procedure in the United States.
Descriptive outcomes were reported due to the small sample size. Median time from the initial surgery to conversion was 27 months range of 17 to Median operating room time was minutes range of to Median length of stay was 48 hours range of 24 to In a systematic review and meta-analysis, Dasari and colleagues examined if mesh prevents post-operative incisional hernia IH in open and laparoscopic bariatric surgery patients. A total of 7 studies met inclusion criteria.
These investigators abstracted data regarding post-operative IH development, surgical site infection, and seroma or wound leakage and performed a meta-analysis. The prophylactic mesh group had significantly decreased odds of developing IH than the standard closure group odds ratio, 0.
No included studies evaluated outcomes after prophylactic mesh during laparoscopic bariatric surgery. The authors concluded that prophylactic mesh during open bariatric surgery appeared to be beneficial in reducing post-operative IH without significant increasing the odds of surgical site infection or seroma or wound leakage.
Moreover, they stated that higher quality studies, including those in laparoscopic patients, and cost-utility analysis, are needed to support routine use of this intervention. Dimitrokallis and colleagues noted that single-incision laparoscopic surgery has attracted a great deal of interest in the surgical community in recent years, including bariatric surgery.
Single-incision laparoscopic sleeve gastrectomy SILSG has been proposed as an alternative to the multi-port laparoscopic procedure; however, it has yet to meet wide acceptance and application. These researchers summarized existing data on SILSG and checked the procedure's feasibility, technical details, safety, and, if possible, outcomes.
They checked the most important databases for studies concerning SILSG and included all these that summarized the criteria placed and contained the data needed for this review. They excluded case reports. A total of 19 studies 1, patients met the selection criteria of this review.
Their mean age was In the majority of cases A wide variety of instruments had been used and mean operating time was One conversion to open surgery was reported and 7. There was a complication rate of 7. Mean EWL for a follow-up of 1 year was achieved in A tendency for less analgesia and better wound satisfaction was reported. However, there is insufficient evidence to recommend it as the new gold standard for sleeve gastrectomy in the place of conventional laparoscopic sleeve gastrectomy.
These investigators stated that RCTs are needed to analyze the results and the possible benefits of this technique. Zaveri et al noted that the increase in the prevalence of obesity and gastro-esophageal reflux disease GERD has paralleled one another. Laparoscopic fundoplication LF Nissen or Toupet is a minimally invasive form of anti-reflux surgery. The duodenal switch DS is a highly effective weight loss surgery with a proven record of long-term weight loss success.
However, fundoplication alone does not give satisfactory results when used for GERD in morbidly obese patients. The variables collected were age, sex, height, weight, intra-operative and post-operative complications, length of stay, operative time, and estimated blood loss.
All revisions were excluded. Descriptive statistics such as mean and standard deviation were used to analyze the data. The total sample size of the study was 5 patients, with a mean age of Weight loss patterns were the same as those without LF. All 5 patients had resolution or improvement in their GERD symptoms within 6 months. Mitzman et al stated that although the DS has been the most effective weight loss surgical procedure, it is a small minority of the total bariatric surgical cases performed.
Modifications that can make the operation technically simpler and reduce a long-term risk of short bowel syndrome would be of benefit. Data from patients who underwent a primary SIPS procedure performed by 2 surgeons at 2 centers from January to August were retrospectively analyzed. All revisions of prior bariatric procedures were excluded. Regression analyses were performed for all follow-up weight loss data. The mean BMI was The authors concluded that modification of the classic DS to one with a single anastomosis and a longer common channel had effective weight loss results.
Morbidity appeared comparable to other stapling reconstructive procedures. Moreover, they stated that future analyses are needed to determine whether a SIPS procedure reduces the risk of future small bowel obstructions and micronutrient deficiencies. Cottam and colleagues stated that in bariatric surgery, the procedure with the highest average weight loss is the bilio-pancreatic diversion with duodenal switch BPDDS.
Additionally, co-morbidity resolution, nutritional data, and complications were also compared. Data were analyzed using both descriptive and comparative statistics. There also was no difference in nutritional data between the 2 procedures pre- and post-op. Complication rates were lower in SIPS however, due to the small sample sizes this is not statistically significant. However, there are fewer complications with SIPS. The main drawbacks of this study were its retrospective design and small sample size.
To convert pounds to kilograms, multiply pounds by 0. To convert inches to meters, multiply inches by 0. For a simple and rapid calculation of BMI, please click below and it will take you to the Obesity Education Initiative.
Clinical Policy Bulletin Notes. Links to various non-Aetna sites are provided for your convenience only. Clinically significant obstructive sleep apnea i.
BMI exceeding 40 with one or more of the following serious co-morbidities: Medically refractory hypertension; or Dyslipidemias; or Nonalcoholic steatohepatitis; or Venous stasis disease; or Significant impairment in activities of daily living; or Intertriginous soft-tissue infections; or Stress urinary incontinence; or Gastroesophageal reflux disease; or Weight-related arthropathies that impair physical activity; or Obesity-related psychosocial distress.
Physician-supervised nutrition and exercise program: This physician-supervised nutrition and exercise program must meet all of the following criteria Member's participation in a physician-supervised nutrition and exercise program must be documented in the medical record by an attending physician who supervised the member's participation.
The nutrition and exercise program may be administered as part of the surgical preparative regimen, and participation in the nutrition and exercise program may be supervised by the surgeon who will perform the surgery or by some other physician. A physician's summary letter is not sufficient documentation. Documentation should include medical records of physician's contemporaneous assessment of patient's progress throughout the course of the nutrition and exercise program. For members who participate in a physician-administered nutrition and exercise program e.
Behavior modification program supervised by qualified professional; and Consultation with a dietician or nutritionist; and Documentation in the medical record of the member's participation in the multi-disciplinary surgical preparatory regimen at each visit. Records must document compliance with the program; the member must not have a net gain in weight during the program. A physician's summary letter, without evidence of contemporaneous oversight, is not sufficient documentation.
Documentation should include medical records of the physician's initial assessment of the member, and the physician's assessment of the member's progress at the completion of the multi-disciplinary surgical preparatory regimen. Aetna considers open or laparoscopic vertical banded gastroplasty VBG medically necessary for members who meet the selection criteria for obesity surgery and who are at increased risk of adverse consequences of a RYGB due to the presence of any of the following co-morbid medical conditions: Demonstrated complications from extensive adhesions involving the intestines from prior major abdominal surgery, multiple minor surgeries, or major trauma; or Hepatic cirrhosis with elevated liver function tests; or Inflammatory bowel disease Crohn's disease or ulcerative colitis ; or Poorly controlled systemic disease American Society of Anesthesiology ASA Class IV see Appendix ; or Radiation enteritis.
Experimental and Investigational Bariatric Surgical Procedures: Aetna considers each of the following procedures experimental and investigational because the peer-reviewed medical literature shows them to be either unsafe or inadequately studied: Gastrointestinal liners endoscopic duodenal-jejunal bypass, endoscopic gastrointestinal bypass devices; e.
Background These criteria were adapted from the NIH Consensus Conference on Surgical Treatment of Morbid Obesity which state that obesity surgery should be reserved only for patients who have first attempted medical therapy: Contraindications to Obesity Surgery: