No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
Endoscopic gastric plication: a network meta-analysis
Abstract
Background
Bariatric surgery is associated with sustainable weight loss and lower mortality. Presently, these procedures can be performed endoscopically. Among endoscopic procedures, endoscopic gastric plication (EGP) is the most studied but has not yet been compared among its variations.
Method
Studies were identified by searching database and reference lists. They would be eligible if they were conducted in adult patients with obesity, did not involve revision, compared EGP and controls, and reported at least 1-year weight loss results. The interventions of interest were endoscopic sleeve gastroplasty (ESG), primary obesity surgery endoluminal (POSE), and transoral gastroplasty (TOGA). The primary outcome was the percentage of excess weight loss (%EWL). From network meta-analysis, treatment comparisons between each intervention were estimated. The interventions were further ranked in terms of maximizing weight loss or minimizing severe adverse events (SAEs).
Results
Significant %EWLs from ESG and POSE versus control were observed at 12 months with pooled mean differences (MDs) and 95% CI of 44.7% (27.95%, 61.45%) and 16.29% (0.32%, 32.26%), respectively. The results also indicated that ESG was more efficacious than POSE [MD (95% CI): 28.41% (5.27%, 51.56%)] and TOGA [MD (95% CI): 36% (11.38%, 60.62%)]. For SAEs, ESG, POSE, and TOGA yielded relative risks (95% CI) of 2.81 (0.14, 56.85), 2.15 (0.13, 36.48), and 3.26 (0.07, 153.3), respectively, compared with the control.
Conclusions
ESG was the best EGP, followed by POSE and TOGA. No significant increase in SAE was indicated from EGP. This network meta-analysis must be updated when more data are available.
ResearchGate has not been able to resolve any citations for this publication.
Introduction
Endoscopic sleeve gastroplasty (ESG) is a novel endoscopic bariatric therapy that complements current medical and surgical therapeutic offerings for weight management and fills an unmet need. Few meta-analyses compared ESG to laparoscopic sleeve gastrectomy (LSG). However, these studies relied on indirect evidence derived from non-comparative studies. Comparative effectiveness data derived from direct comparative studies is needed. We performed a meta-analysis of studies that directly compared ESG with LSG.
Methods
A comprehensive search of PubMed, Embase, and Cochrane databases was conducted. Single-arm studies were excluded. Pooled mean difference (MD) and risk ratio (RR) with 95% confidence intervals (CIs) were obtained within a random-effect model.
Results
Seven studies with 6,775 patients (3,413 with ESG vs. 3,362 with LSG) were included. There were significant differences in 6-month (MD − 7.48; 95% CI − 10.44, − 4.52; P < 0.00001), 12-month (MD − 9.90; 95% CI − 10.59, − 9.22; P < 0.00001), and 24-month (MD − 7.63; 95% CI − 11.31, − 3.94; P < 0.0001) TBWL% favoring LSG over ESG. There was a trend toward lower incidence of adverse events with ESG compared to LSG but did not reach statistical significance (RR 0.51, 95% CI 0.23–1.11, P = 0.09). The incidence of new-onset gastroesophageal reflux disease (GERD) was significantly lower after ESG compared to LSG, 1.3% vs. 17.9%, respectively (RR 0.10, 95% CI 0.02–0.53, P = 0.006).
Conclusions
ESG achieved clinically adequate but lower short- and mid-term weight loss when compared to LSG, with fewer adverse events, including GERD. Given the stomach-sparing nature of ESG and acceptable safety profile, it provides an acceptable alternative to LSG for patients with mild-to-moderate obesity.
Graphical abstract
Background
Primary obesity surgery endoluminal (POSE) utilizes an incision-less operating platform system to create full-thickness plications in the gastric fundus and body (original POSE). Many studies have demonstrated the safety and efficacy of original POSE for the treatment of obesity.Objective
We aimed to conduct a systematic review and meta-analysis of available literature in an attempt to evaluate the outcomes of original POSE per the ASGE task force thresholds.Methods
Bibliographic databases were systematically searched for studies assessing the outcomes of POSE for the treatment of obesity. All randomized controlled trials (RCTs) and observational studies that assessed outcomes of POSE were included. Studies were included if they reported percent total weight loss (%TWL) or percent excess weight loss (%EWL) and the incidence of serious adverse events (SAE).ResultsA total of seven studies with 613 patients were included. Two included studies were RCTs, while the remaining were observational studies. Pooled mean %EWL at 3–6 months and 12–15 months were 42.62 (95% CI 37.56–47.68) and 48.86 (95% CI 42.31–55.41), respectively. Pooled mean %TWL at 3–6 months and 12–15 months was 13.45 (95% CI 8.93–17.97) and 12.68 (95% CI 8.13–17.23), respectively. Subgroup analysis of two RCTs showed that weight loss at 1 year was significantly higher in POSE patients (%EWL difference in means 19.45 (95% CI 4.65–34.24, p value = 0.01). The overall incidence of serious adverse events was only 2.84% and included GI bleeding, extra-gastric bleeding, hepatic abscess, severe pain, severe nausea, and severe vomiting. The mean number of total anchors placed in the fundus and body was 13.18 (95% CI 11.77–14.58), and the mean procedure time was 44.55 min (95% CI 36.44–52.65).ConclusionPOSE, a minimally invasive endoscopic bariatric therapy, is a safe and effective modality for the treatment of obesity. The outcomes of POSE meet and surpass the ASGE joint task force thresholds. Future studies should evaluate newer versions of this procedure that emphasize gastric body plication sparing the fundus.
Background
We aimed to individually evaluate IGB and ESG procedures and compare the efficacy, durability, and safety of these procedures.Methods
Bibliographic databases were systematically searched for studies investigating the use of IGB and ESG for the treatment of obesity. Studies reporting percent total weight loss (%TWL) or percent excess weight loss (%EWL) with at least 12 months of follow-up were included.ResultsA total of 28 studies were included in the final analysis. Only 1 study directly compared ESG to IGB, 9 studies evaluated ESG alone, while 18 studies evaluated IGB. At 12-month follow-up after ESG, mean %TWL was 17.51 (95% CI 16.44–18.58), and %EWL was 60.51 (95% CI 54.39–66.64). Mean %TWL and %EWL after IGB at 12 months was 10.35 (95% CI 8.38–12.32) and 29.65 (95% CI 25.40–33.91), respectively. Mean %TWL and %EWL after IGB were significantly decreased at 18 or 24 months compared to 6 months indicating weight regain after IGB removal. ESG achieved significantly superior weight loss compared to IGB, the difference in mean %TWL was 7.33 (95% CI 5.22–9.44, p value = 0.0001) at 12 months. Serious adverse events were observed in < 5% for both procedures.Conclusion
Although ESG and IGB are safe and effective for weight loss, our study suggests that ESG results in more significant and sustained weight loss. Nevertheless, a variety of approaches are essential to care for this underserved population, and there are several factors other than weight loss that should be considered in selecting the ideal therapy for individual patients.
Background
The evaluation of the credibility of results from a meta-analysis has become an important part of the evidence synthesis process. We present a methodological framework to evaluate confidence in the results from network meta-analyses, Confidence in Network Meta-Analysis (CINeMA), when multiple interventions are compared.
Methodology
CINeMA considers 6 domains: (i) within-study bias, (ii) reporting bias, (iii) indirectness, (iv) imprecision, (v) heterogeneity, and (vi) incoherence. Key to judgments about within-study bias and indirectness is the percentage contribution matrix, which shows how much information each study contributes to the results from network meta-analysis. The contribution matrix can easily be computed using a freely available web application. In evaluating imprecision, heterogeneity, and incoherence, we consider the impact of these components of variability in forming clinical decisions.
Conclusions
Via 3 examples, we show that CINeMA improves transparency and avoids the selective use of evidence when forming judgments, thus limiting subjectivity in the process. CINeMA is easy to apply even in large and complicated networks.
Background
Endoscopic sleeve gastroplasty (ESG) has emerged as a promising technique in endoscopic bariatric and metabolic therapies (EBMTs). We aimed to perform a systematic review and meta-analysis to provide an update on its efficacy and safety.Methods
This is a systematic review and meta-analysis was performed following the PRISMA guidelines. MEDLINE, Cochrane, EMBASE, and LILACS were searched to identify the studies related to ESG.ResultsEleven studies with a total of 2170 patients were included. The average BMI pre-ESG was 35.78 kg/m2. Pooled mean %TWL observed at 6, 12, and 18 months was 15.3%, 16.1%, and 16.8% respectively. Pooled mean %EWL at 6, 12, and 18 months was 55.8%, 60%, and 73% respectively. No procedure-related mortality was reported.ConclusionESG is a safe and effective procedure for primary obesity therapy with promising short- and mid-term results.
Background & aims:
Bariatric surgery is the most successful treatment for obesity. However, many patients avoid surgery due to its perceived invasive nature and fear of complications. Endoscopic sleeve gastroplasty (ESG) is a seemingly less invasive option for patients with obesity. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of ESG in adults.
Methods:
We searched MEDLINE, Embase, Web of Science, and Cochrane Library through July 2019. Investigated outcomes included the percent total body weight loss (TBWL), body mass index reduction, percent excess weight loss (EWL), and adverse events.
Results:
We extracted data from 8 original studies, published from 2016 through 2019, which included a total of 1772 patients. At 6 months, mean TBWL was 15.1% (95% CI, 14.3-16.0), mean decrease in body mass index was 5.65 kg/m2 (95% CI, 5.07-6.22), and mean excess weight loss was 57.7% (95% CI, 52.0-63.4). Weight loss was sustained at 12 months and 18-24 months with a TBWL of 16.5% (95% CI, 15.2-17.8) and 17.2% (95% CI, 14.6-19.7), respectively. The pooled post-ESG rate of severe adverse events was 2.2% (95% CI, 1.6%-3.1%], including pain or nausea requiring hospitalization (n = 18, 1.08%), upper gastrointestinal bleeding (n=9, 0.56%), and peri-gastric leak or fluid collection (n = 8, 0.48%).
Conclusions:
In a systematic review and meta-analysis, we found ESG to produce clinically significant weight loss that was reproducible among independent centers and to have a low rate of severe adverse events. ESG appears to be an effective intervention for patients with obesity, although comparative studies and randomized controlled trials are necessary. PROSPERO Identifier: CRD42019121921.
Background
Endoscopic sleeve gastroplasty (ESG) is a minimally invasive, effective, and safe technique for weight loss intervention. Since a relatively small number of cases were present in previous studies, this study aimed to elucidate the efficacy and safety of ESG.
Methods
Relevant publications were identified through searching PubMed, EMBASE, Cochrane, and Web of Science before March 1, 2019. The percentage of total body weight loss (%TBWL), percentage of excess weight loss (%EWL), and the adverse event rate in each follow-up session were extracted, pooled, and analyzed. Forest plots were graphed based on random effects models.
Results
A total of 1542 patients from nine studies were eligible for analysis. The pooled results of %TBWL at 1, 3, 6, and 12 months were 8.78% (p = 0.000), 11.85% (p = 0.000), 14.47% (p = 0.024), and 16.09% (p = 0.063), respectively. The pooled results of %EWL at 1, 3, 6, and 12 months were 31.16% (p = 0.000), 43.61% (p = 0.000), 53.14% (p = 0.000), and 59.08% (p = 0.015), respectively. Finally, the pooled rate of mild adverse events was 72% (p < 0.01), and the pooled estimate of severe adverse events was only 1% (p = 0.08).
Conclusion
Although the conventional surgical sleeve gastrectomy is the gold standard for bariatric surgery, ESG could be a promising minimally invasive alternative for treating obesity with satisfactory efficacy and low risk.
Endoscopic gastric plication or gastroplasty for morbid obesity is gaining worldwide recognition. Data concerning safety and efficacy are rather scarce. Furthermore, clear guidelines are yet to be established. The objective of this meta-analysis is to update the data and investigate the efficacy and safety of the procedure. An online comprehensive search using Cochrane, Google Scholar, PubMed, Web of Science, and Embase on endoscopic gastric plication was completed. The primary outcome was defined as weight loss at 6 months or more after the procedure. Secondary outcomes were defined as the occurrence of adverse events or complications including insufficient weight loss or regain. I² statistic was used to define the heterogeneity across studies. Twenty-two cohort studies on 7 different devices met the inclusion criteria, with a total of 2475 patients. The mean baseline BMI was 37.8 ± 4.1 kg/m² (median 37.9; range 28.0–60.2). Either a transoral endoluminal stapling or (suction based) (full-thickness) stitching and/or anchor device was used to obtain gastric volume reduction and/or alter gastric outlet. The mean follow-up was 13 months (median 12; range 6–24) for the specified outcomes of each study. Two active, FDA-approved devices were taken into account for meta-analysis: Endoscopic sleeve gastroplasty (ESG) and the primary obesity surgery endolumenal (POSE™). Average pooled %EWL at 6 months (p = 0.02) and 12 months (p = 0.04) in favor of ESG was 57.9 ± 3.8% (50.5–65.5, I² = 0.0), 44.4 ± 2.1% (40.2–48.5, I² = 0.0), and 68.3 ± 3.8% (60.9–75.7, I² = 5.8), 44.9 ± 2.1% (40.9–49.0, I² = N/A) for ESG and POSE respectively. Major adverse events without mortality were described in 25 patients (9 studies, p = 0.63). ESG and POSE are both safe and feasible procedures with good short-term weight loss. ESG seems to be superior in terms of weight loss at this point. Few major adverse events are reported and long-term results are awaited.
Background and Aims
Novel endoscopic procedures (endoscopic sleeve gastroplasty (ESG), AspireAssist (AA), and primary obesity surgery endolumenal (POSE)) have been developed for treatment of obesity. We aimed to conduct a systematic review and meta-analysis to evaluate and compare the efficacy of these three endoscopic procedures.
Methods
Main outcomes of interest were percent excess weight loss (%EWL) and percent total body weight loss (%TBWL). Weighted pooled means (WPMs) were calculated and analyzed using random effects model. Mean differences (MDs) were calculated to compare these procedures.
Results
Twelve studies with 1149 patients were included. WPMs for %EWL at 6 and 12 months with ESG were 49.67 (45.67, 53.66) and 52.75 (43.52, 61.98), respectively, while %TBWLs at 6 and 12 months with ESG were 16.01 (15.10, 16.92) and 17.41 (17.08, 17.74), respectively. WPMs for %EWL at 6 and 12 months with POSE were 43.79 (40.17, 47.42) and 44.91 (40.90, 48.92), respectively. WPM for %EWL at 12 months with AA was 50.85 (46.03, 55.68). While comparing ESG and POSE, at 6 months and 12 months, MD for %EWL was 6.17 (1.07, 11.26; P = 0.01) and 7.84 (− 2.05, 17.71; P = 0.06) in favor of ESG. No difference in %EWL was observed while comparing ESG with AA (P = 0.29). Likewise, MD for %EWL to compare AA and POSE was not significant (P = 0.68).
Conclusions
During a follow-up of 6–12 months, both AA and ESG had excellent efficacy in achieving significant and sustained weight loss; however, ESG was found to be superior in terms of weight loss when compared with POSE.
Endoscopic bariatric therapies (EBTs) are promising alternatives to conventional surgery for obesity. The aim of this study is to compare efficacy and safety through a systematic review and meta-analysis of the endoscopic gastroplasty techniques versus conservative treatment. We searched MEDLINE, EMBASE, Cochrane CENTRAL, Lilacs/Bireme. Randomized controlled trials (RCTs) enrolling obese patients comparing endoscopic gastroplasty to sham or diet/exercise were considered eligible. Among 6014 records, three RCTs were selected for meta-analysis. The total sample was 459 patients (312 EBTs vs 147 control). Mean total body weight loss in the intervention group (IG) was 4.8% higher than the control group (CG) at 12 months (p = 0.01). The IG responder rate was 44.31% at 12 months. Therefore, the endoscopic gastroplasty is more effective than conservative therapies but do not achieve FDA thresholds.
The number of published systematic reviews of studies of healthcare interventions has increased rapidly and these are used extensively for clinical and policy decisions. Systematic reviews are subject to a range of biases and increasingly include non-randomised studies of interventions. It is important that users can distinguish high quality reviews. Many instruments have been designed to evaluate different aspects of reviews, but there are few comprehensive critical appraisal instruments. AMSTAR was developed to evaluate systematic reviews of randomised trials. In this paper, we report on the updating of AMSTAR and its adaptation to enable more detailed assessment of systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. With moves to base more decisions on real world observational evidence we believe that AMSTAR 2 will assist decision makers in the identification of high quality systematic reviews, including those based on non-randomised studies of healthcare interventions.
Background
Pose
SM
is an endolumenal weight-loss intervention in which suture anchors are placed endoscopically in the gastric fundus/distal gastric body. Observational studies of pose have shown safe, effective weight loss. Twelve-month results of a randomized controlled trial comparing weight loss and satiety after pose vs. conventional medical therapy are reported.
Methods
Subjects with classes I–II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only (control). Pose subjects received gastric fundus and distal body suture-anchor plications with diet/exercise counseling. Total body (%TBWL) and excess weight loss (%EWL) were assessed at 6 and 12 months. Analysis of covariance (ANCOVA) was used to analyze 12-month %TBWL. Satiety changes were assessed at 6 and 12 months.
Results
From November 2013 to July 2014, 44 subjects were randomized (34, 77.3 % female; mean age, 38.3 ± 10.7 years; body mass index, 36.5 ± 3.4 kg/m2) to pose (n = 34) or control (n = 10) groups in three centers. Mean pose procedure time was 51.8 ± 14.5 min; pose subjects received a mean 8.8 ± 1.3 fundal and 4.2 ± 0.7 distal body plications. Twelve-month TBWL: pose, 13.0 % (EWL, 45.0 %), n = 30 vs. control group, 5.3 % (18.1 %), n = 9; significant mean difference, 7.7 % (95 % CI 2.2, 13.2; p < 0.01). Pose subjects showed significant reductions in satiety parameters (p < 0.001); controls experienced reduced caloric intake and satiety volume (p < 0.05). No serious device- or procedure-related adverse events occurred.
Conclusions
In a randomized controlled trial at 12 months, pose-treated subjects had significantly greater weight loss than those treated with diet/exercise guidance alone. At 6 and 12 months, pose subjects showed significant reduction in satiety parameters.
Study registration: clinicaltrials.gov identifier # NCT01843231
Public health officials and organizations have disseminated health messages regarding the dangers of obesity, but these have not produced the desired effect.
To estimate the expected number of years of life lost (YLL) due to overweight and obesity across the life span of an adult.
Data from the (1) US Life Tables (1999); (2) Third National Health and Nutrition Examination Survey (NHANES III; 1988-1994); and (3) First National Health and Nutrition Epidemiologic Follow-up Study (NHANES I and II; 1971-1992) and NHANES II Mortality Study (1976-1992) were used to derive YLL estimates for adults aged 18 to 85 years. Body mass index (BMI) integer-defined categories were used (ie, <17; 17 to <18; 18 to <19; 20 to <21; 21 to 45; or > or =45). A BMI of 24 was used as the reference category.
The difference between the number of years of life expected if an individual were obese vs not obese, which was designated YLL.
Marked race and sex differences were observed in estimated YLL. Among whites, a J- or U-shaped association was found between overweight or obesity and YLL. The optimal BMI (associated with the least YLL or greatest longevity) is approximately 23 to 25 for whites and 23 to 30 for blacks. For any given degree of overweight, younger adults generally had greater YLL than did older adults. The maximum YLL for white men aged 20 to 30 years with a severe level of obesity (BMI >45) is 13 and is 8 for white women. For men, this could represent a 22% reduction in expected remaining life span. Among black men and black women older than 60 years, overweight and moderate obesity were generally not associated with an increased YLL and only severe obesity resulted in YLL. However, blacks at younger ages with severe levels of obesity had a maximum YLL of 20 for men and 5 for women.
Obesity appears to lessen life expectancy markedly, especially among younger adults.
Obesity is associated with increased mortality. Weight loss improves cardiovascular risk factors, but no prospective interventional studies have reported whether weight loss decreases overall mortality. In fact, many observational studies suggest that weight reduction is associated with increased mortality.
The prospective, controlled Swedish Obese Subjects study involved 4047 obese subjects. Of these subjects, 2010 underwent bariatric surgery (surgery group) and 2037 received conventional treatment (matched control group). We report on overall mortality during an average of 10.9 years of follow-up. At the time of the analysis (November 1, 2005), vital status was known for all but three subjects (follow-up rate, 99.9%).
The average weight change in control subjects was less than +/-2% during the period of up to 15 years during which weights were recorded. Maximum weight losses in the surgical subgroups were observed after 1 to 2 years: gastric bypass, 32%; vertical-banded gastroplasty, 25%; and banding, 20%. After 10 years, the weight losses from baseline were stabilized at 25%, 16%, and 14%, respectively. There were 129 deaths in the control group and 101 deaths in the surgery group. The unadjusted overall hazard ratio was 0.76 in the surgery group (P=0.04), as compared with the control group, and the hazard ratio adjusted for sex, age, and risk factors was 0.71 (P=0.01). The most common causes of death were myocardial infarction (control group, 25 subjects; surgery group, 13 subjects) and cancer (control group, 47; surgery group, 29).
Bariatric surgery for severe obesity is associated with long-term weight loss and decreased overall mortality.
Background
Endoscopic sleeve gastroplasty (ESG) is an endolumenal, organ-sparing therapy for obesity, with wide global adoption. We aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone.
Methods
We conducted a randomised clinical trial at nine US centres, enrolling individuals aged 21–65 years with class 1 or class 2 obesity and who agreed to comply with lifelong dietary restrictions. Participants were randomly assigned (1:1·5; with stratified permuted blocks) to ESG with lifestyle modifications (ESG group) or lifestyle modifications alone (control group), with potential retightening or crossover to ESG, respectively, at 52 weeks. Lifestyle modifications included a low-calorie diet and physical activity. Participants in the primary ESG group were followed up for 104 weeks. The primary endpoint at 52 weeks was the percentage of excess weight loss (EWL), with excess weight being that over the ideal weight for a BMI of 25 kg/m². Secondary endpoints included change in metabolic comorbidities between the groups. We used multiple imputed intention-to-treat analyses with mixed-effects models. Our analyses were done on a per-protocol basis and a modified intention-to-treat basis. The safety population was defined as all participants who underwent ESG (both primary and crossover ESG) up to 52 weeks.
Findings
Between Dec 20, 2017, and June 14, 2019, 209 participants were randomly assigned to ESG (n=85) or to control (n=124). At 52 weeks, the primary endpoint of mean percentage of EWL was 49·2% (SD 32·0) for the ESG group and 3·2% (18·6) for the control group (p<0·0001). Mean percentage of total bodyweight loss was 13·6% (8·0) for the ESG group and 0·8% (5·0) for the control group (p<0·0001), and 59 (77%) of 77 participants in the ESG group reached 25% or more of EWL at 52 weeks compared with 13 (12%) of 110 in the control group (p<0·0001). At 52 weeks, 41 (80%) of 51 participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, compared with the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 (68%) of 60 participants in the ESG group maintained 25% or more of EWL. ESG-related serious adverse events occurred in three (2%) of 131 participants, without mortality or need for intensive care or surgery.
Interpretation
ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities. ESG should be considered as a synergistic weight loss intervention for patients with class 1 or class 2 obesity. This trial is registered with ClinicalTrials.gov, NCT03406975.
Funding
Apollo Endosurgery, Mayo Clinic.
Background & aims:
Endoscopic bariatric therapies are less invasive alternatives and endoscopic gastroplasty (ESG) represents the latest evolution. This study aims to compare weight loss, safety and comorbidity resolution of ESG compared to laparoscopic sleeve gastrectomy (LSG).
Methods:
This was a propensity score matched study of patients who underwent LSG or ESG. Primary outcome was weight loss at 6, 12, 24, and 36 months. A non-inferiority margin of 10% total weight loss (%TWL) was used. The secondary outcomes were safety and comorbidity resolution.
Results:
1:1 propensity score matching yielded 3018 patient pairs. Average age and body mass index (BMI) were 34 ± 10 years and 33± 3 kg/m2, respectively and 89% were female. Mean %excess weight loss (%EWL) at one, two, and three years after ESG was 77.1 ± 24.6%, 75.2 ± 47.9%, and 59.7 ± 57.1% respectively. Mean %EWL at one, two, and three years after LSG was 95.1 ± 20.5%, 93.6 ± 31.3%, and 74.3 ± 35.2%, respectively. %TWL mean difference (95% confidence interval; p-value) was 9.7 (6.9-11.8; p<0.001) %, 6.0 (-2.0-9.4; p<0.001) % and 4.8 (-1.5-8.7; p<0.001) % at one, two, and three years, respectively. Non-inferiority was demonstrated at all follow-up visits. Fourteen ESG patients developed adverse events (0.5%) vs ten LSG patients (0.3%). Co-morbidity remission rates after ESG vs LSG were 64% vs 82% for diabetes, 66% vs 64% for dyslipidemia, and 51% vs 46% for hypertension, respectively. Eighty ESG patients (2.7%) underwent revision to LSG for insufficient weight loss or weight regain, and 28 had re-suturing after primary ESG (0.9%).
Conclusions:
ESG induces non-inferior weight loss to LSG with similar co-morbidity resolution and safety profiles.
The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.
Objective
Endoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium).
Design
Eligible patients (body mass index 30–40 kg/m ² ) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG.
Results
Of the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%.
Conclusions
This study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment.
Trial registration number
NCT03255005 .
Background The comparative efficacy of bariatric endoscopic procedures has not been completely elucidated. We aimed to comprehensively evaluate the efficacy of bariatric endoscopic procedures.
Methods We searched for randomized controlled trials investigating the efficacy of bariatric endoscopic procedures, including the use of an intragastric balloon, duodenal-jejunal bypass liner (DJBL), aspiration therapy, primary obesity surgery endoluminal (POSE) procedure, and botulinum toxin injection to the stomach. Network meta-analyses were performed to determine the percentage of weight loss (%weight loss) and percentage of excess weight loss (%EWL).
Results 22 studies with 2141 patients were included in the meta-analysis. Most endoscopic procedures showed superior efficacy in terms of %weight loss compared with the control (mean difference [MD] [95 % confidence interval (CI)]: aspiration therapy 10.4 % [7.0 % to 13.7 %]; fluid-filled balloon 5.3 % [3.4 % to 7.2 %]; POSE 4.9 % [1.7 % to 8.2 %]; and DJBL 4.5 % [1.4 % to 7.7 %]). In terms of %EWL, aspiration therapy, fluid-filled balloon, POSE, and DJBL were superior to the control (MD [95 %CI]: 27.3 % [15.3 % to 39.3 %]; 22.4 % [15.4 % to 29.4 %]; 15.3 % [2.5 % to 28.0 %]; and 13.0 % [4.9 % to 21.2], respectively). The gas-filled balloon and botulinum toxin injection did not show a significant difference in %weight loss or %EWL compared with the control. For the fluid-filled balloon, the %EWL and %weight loss tended to decrease after balloon removal at 6 months after the procedure.
Conclusion All bariatric endoscopic procedures, except for gas-filled balloon and botulinum toxin injection to the stomach, showed superior short-term efficacy in terms of %weight loss or %EWL compared with lifestyle modification.
Background:
Endoscopic sleeve gastroplasty (ESG) has gained momentum as a promising, minimally invasive bariatric therapy worldwide.
Objective:
We performed the first comprehensive systematic review and meta-analysis of studies to evaluate the efficacy, safety, and procedural technique of ESG.
Methods:
Bibliographic databases were systematically searched for studies assessing patients who underwent ESG for the treatment of obesity. Studies were included if they reported percent total weight loss or percent excess weight loss and the incidence of serious adverse events. Studies with <15 patients, follow-up period <6 months, and overlapping patients were excluded.
Results:
Eight observational studies with 1859 patients were included. Pooled mean percent total weight loss at 6, 12, and 24 months was 14.86 (95% confidence interval [CI]: 13.83-15.90), 16.43 (95%CI: 15.23-17.63), and 20.01 (95%CI: 16.92-23.11), respectively. Pooled mean percent excess weight loss at 6, 12, and 24 months was 55.75 (95%CI: 50.61-60.89), 61.84 (95%CI: 54.75-68.93), and 60.40 (95%CI: 48.88-71.92), respectively. The pooled incidence of serious adverse events was 2.26% (95%CI 1.25-4.03) and no mortality was reported. Gastrointestinal bleeding and perigastric fluid collection were the most common reported serious adverse events; however, the pooled incidence of both was <1%. Variations in procedural technique were seen, but the full-thickness nature of suturing was reported in all studies. A layer of reinforcement sutures was performed in the majority of studies (n = 6). Limitations include the lack of controlled studies, long-term follow-up data, and standardization of technique.
Conclusion:
ESG, a minimally invasive bariatric therapy, is reproducible among centers worldwide with effective weight loss and favorable safety profile outcomes. Controlled studies would be valuable to further corroborate these findings.
Background and aims:
Endoscopic sleeve gastroplasty (ESG) is a safe and effective minimally invasive bariatric procedure. This study compared weight loss in patients undergoing ESG with that of matched patients undergoing high-intensity diet and lifestyle therapy (HIDLT).
Methods:
In this case-matched study, patients were matched 2/3:1 (HIDLT:ESG) by age, sex, and body mass index (BMI). 105 patients (30 male) who underwent ESG + low-intensity diet and lifestyle therapy (LIDLT) between 2016 and 2018 were compared with 281 patients (92 males) who underwent HIDLT at the Johns Hopkins Medical Institutions in 2013 to 2014. Weight was evaluated 1, 3, 6, and 12 months after beginning HIDLT or post-ESG to determine the mean percent total body weight loss (%TBWL).
Results:
Mean age across both cohorts was 48.0 ± 12.1 and baseline BMI was 40.0 ± 7.7 kg/m2. In multivariable analysis controlling for age, sex, and baseline BMI, the mean %TBWL at 1, 3, 6, and 12 months was significantly higher in patients undergoing ESG than matched patients undergoing HIDLT. Specifically, at 3 months, the mean TBWL in the ESG cohort was 14.0% compared with 11.3% in the HIDLT cohort (p <0.011), and at 12 months, the mean TBWL in the ESG cohort was 20.6% versus 14.3% in the HIDLT cohort (p <0.001). ESG patients with baseline BMI ≤40 kg/m2 continued to show significantly greater %TBWL than those of the same BMI group in the HIDLT group at 1, 3, 6 and 12 months after intervention (3 month: Coeff.: 3.43 (p <0.001), 12 month: Coeff.: 8.14 (p <0.001).
Conclusions:
Through 12 months of follow-up, patients who underwent ESG achieved significantly greater weight loss than patients enrolled in HIDLT. ESG appears to be a valuable alternative for patients who experience difficulty adhering to HIDLT.
Assessment of risk of bias is regarded as an essential component of a systematic review on the effects of an intervention. The most commonly used tool for randomised trials is the Cochrane risk-of-bias tool. We updated the tool to respond to developments in understanding how bias arises in randomised trials, and to address user feedback on and limitations of the original tool.
Background and aims:
Endoscopic sleeve gastroplasty (ESG) reduces the gastric lumen to a size comparable to that of laparoscopic sleeve gastrectomy (LSG). Yet, there is a paucity of research comparing outcomes between the 2 procedures. Our study compared the 6-month weight loss outcomes and adverse events of ESG with LSG in a case-matched cohort.
Methods:
Retrospective review of prospectively collected data for patients undergoing ESG or LSG at a single academic center. Weight was recorded at 1 and 6 months postprocedure and percent total body weight loss (%TBWL) was calculated. Adverse events and new-onset GERD were also recorded.
Results:
A total of 54 ESG patients were matched to 83 LSG patients by age, sex, and body mass index (BMI). The proportion of patients with GERD at baseline was similar in the 2 groups (16.7% in ESG group vs 25.3% in LSG group, p =0.27. At 6-month follow-up, %TBWL (compared with baseline) was significantly lower in the ESG group compared with the LSG group (17.1% ± 6.5 vs 23.6% ±7.6, p < 0.01). ESG patients had significantly lower rate of adverse events compared with LSG patients (5.2% vs 16.9%, p < 0.05). New-onset GERD was also significantly lower in the ESG group compared with the LSG group (1.9% vs 14.5%, p < 0.05).
Conclusions:
ESG, a minimally invasive same-day procedure, achieved less weight loss at 6 months than LSG, with the caveat that LSG caused more adverse events and new onset GERD than ESG.
Objective:
Evaluate safety and efficacy of the pose™ procedure for obesity treatment.
Methods:
Subjects with Class I to II obesity were randomized (2:1) to receive active or sham procedure, after each investigator performed unblinded lead-in cases. All subjects were provided low-intensity lifestyle therapy. Efficacy end points were the mean difference in percent total body weight loss (%TBWL) at 12 months between randomized groups, and responder rate achieving ≥5% TBWL. The primary safety end point was incidence of reported adverse events.
Results:
Three hundred thirty-two subjects were randomized (active, n = 221; sham, n = 111); thirty-four subjects were included in the unblinded lead-in cohort. Twelve-month results were mean TBWL 7.0 ± 7.4% in lead-in, 4.95 ± 7.04% in active, and 1.38 ± 5.58% in sham groups, respectively. Responder rate was 41.55% in active and 22.11% in sham groups, respectively (P < 0.0001); mean responder result was 11.5% TBWL. The differences observed between active and sham groups for co-primary end points were statistically significant (P < 0.0001); however, super superiority margin as set forth in the study design was not met. No unanticipated adverse events or deaths occurred. Procedure-related serious adverse event rates were 5.0% (active) and 0.9% (sham), P = 0.068.
Conclusions:
The pose procedure was safe and resulted in statistically significant and clinically meaningful weight loss over sham through 1 year.
The epidemic in obesity has led to an increase in number of so called bariatric procedures. Doctors are less comfortable managing an obese patient after bariatric surgery. Peri-operative mortality is less than 1%. The specific feature in the obese patient is that the classical signs of peritoneal irritation are never present as there is no abdominal wall and therefore no guarding or rigidity. Simple post-operative tachycardia in obese patients should be taken seriously as it is a WARNING SIGNAL. The most common complication after surgery is peritonitis due to anastomotic fistula formation. This occurs typically as an early complication within the first 10 days post-operatively and has an incidence of 1 to 6% after gastric bypass and 3 to 7% after sleeve gastrectomy. Post-operative malnutrition is extremely rare after restrictive surgery (ring, sleeve gastrectomy) although may occur after mal absorbative surgery (bypass, biliary pancreatic shunt) and is due to the restriction and change in absorption. Prophylactic cholecystectomy is not routinely carried out during the same procedure as the bypass. Superior mesenteric vein thrombosis after bariatric surgery is a diagnosis which should be considered in the presence of any postoperative abdominal pain. Initially a first etiological assessment is performed (measurement of antithrombin III and of protein C and protein S, testing for activated protein C resistance). if the least doubt is present, a medical or surgical consultation should be requested with a specialist practitioner in the management of obese patients as death rates increase with delayed diagnosis.
A group of 200 morbidly obese men (average weight, 143.5 kg; age, 23 to 70 years) were admitted to a weight control program between 1960 and 1977 and were followed up for a mean period of 7 1/2 years. There was complete follow-up until the termination of the study or until death for 185 men. Fifteen men were followed up for fractional periods. Fifty of the 200 died during the course of the study. Life-table techniques, comparing the mortality among the obese with that among men in the general population, demonstrated a 12-fold excess mortality in the obese in the age group 25 to 34 years and a sixfold excess in the age group 35 to 44 years. This ratio diminished with advancing age. Cardiovascular disease was reported as the cause of death more frequently and malignancies less frequently than they were for men in the US general population.(JAMA 243:443-445, 1980)
This study tested the hypothesis that weight-reduction (bariatric) surgery reduces long-term mortality in morbidly obese patients.
Obesity is a significant cause of morbidity and mortality. The impact of surgically induced, long-term weight loss on this mortality is unknown.
We used an observational 2-cohort study. The treatment cohort (n = 1035) included patients having undergone bariatric surgery at the McGill University Health Centre between 1986 and 2002. The control group (n = 5746) included age- and gender-matched severely obese patients who had not undergone weight-reduction surgery identified from the Quebec provincial health insurance database. Subjects with medical conditions (other then morbid obesity) at cohort-inception into the study were excluded. The cohorts were followed for a maximum of 5 years from inception.
The cohorts were well matched for age, gender, and duration of follow-up. Bariatric surgery resulted in significant reduction in mean percent excess weight loss (67.1%, P < 0.001). Bariatric surgery patients had significant risk reductions for developing cardiovascular, cancer, endocrine, infectious, psychiatric, and mental disorders compared with controls, with the exception of hematologic (no difference) and digestive diseases (increased rates in the bariatric cohort). The mortality rate in the bariatric surgery cohort was 0.68% compared with 6.17% in controls (relative risk 0.11, 95% confidence interval 0.04-0.27), which translates to a reduction in the relative risk of death by 89%.
This study shows that weight-loss surgery significantly decreases overall mortality as well as the development of new health-related conditions in morbidly obese patients.
Weight loss is associated with short-term amelioration and prevention of metabolic and cardiovascular risk, but whether these benefits persist over time is unknown.
The prospective, controlled Swedish Obese Subjects Study involved obese subjects who underwent gastric surgery and contemporaneously matched, conventionally treated obese control subjects. We now report follow-up data for subjects (mean age, 48 years; mean body-mass index, 41) who had been enrolled for at least 2 years (4047 subjects) or 10 years (1703 subjects) before the analysis (January 1, 2004). The follow-up rate for laboratory examinations was 86.6 percent at 2 years and 74.5 percent at 10 years.
After two years, the weight had increased by 0.1 percent in the control group and had decreased by 23.4 percent in the surgery group (P<0.001). After 10 years, the weight had increased by 1.6 percent and decreased by 16.1 percent, respectively (P<0.001). Energy intake was lower and the proportion of physically active subjects higher in the surgery group than in the control group throughout the observation period. Two- and 10-year rates of recovery from diabetes, hypertriglyceridemia, low levels of high-density lipoprotein cholesterol, hypertension, and hyperuricemia were more favorable in the surgery group than in the control group, whereas recovery from hypercholesterolemia did not differ between the groups. The surgery group had lower 2- and 10-year incidence rates of diabetes, hypertriglyceridemia, and hyperuricemia than the control group; differences between the groups in the incidence of hypercholesterolemia and hypertension were undetectable.
As compared with conventional therapy, bariatric surgery appears to be a viable option for the treatment of severe obesity, resulting in long-term weight loss, improved lifestyle, and, except for hypercholesterolemia, amelioration in risk factors that were elevated at baseline.
Endoscopic sleeve gastroplasty, laparoscopic sleeve gastrectomy, and laparoscopic greater curve plication: do they differ at 2 years?
- Lopez-Nava