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BACKGROUND: Whether the benefits of the robotic platform in bariatric surgery translate into superior surgical outcomes remains unclear. The aim of this retrospective study was to establish the 'best possible' outcomes for robotic bariatric surgery and compare them with the established laparoscopic benchmarks. METHODS: Benchmark cut-offs were established for consecutive primary robotic bariatric surgery patients of 17 centres across four continents (13 expert centres and 4 learning phase centres) using the 75th percentile of the median outcome values until 90 days after surgery. The benchmark patients had no previous laparotomy, diabetes, sleep apnoea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, history of thromboembolic events, BMI greater than 50â kg/m2, or age greater than 65 years. RESULTS: A total of 9097 patients were included, who were mainly female (75.5%) and who had a mean(s.d.) age of 44.7(11.5) years and a mean(s.d.) baseline BMI of 44.6(7.7) kg/m2. In expert centres, 13.74% of the 3020 patients who underwent primary robotic Roux-en-Y gastric bypass and 5.9% of the 4078 patients who underwent primary robotic sleeve gastrectomy presented with greater than or equal to one complication within 90 postoperative days. No patient died and 1.1% of patients had adverse events related to the robotic platform. When compared with laparoscopic benchmarks, robotic Roux-en-Y gastric bypass had lower benchmark cut-offs for hospital stay, postoperative bleeding, and marginal ulceration, but the duration of the operation was 42â min longer. For most surgical outcomes, robotic sleeve gastrectomy outperformed laparoscopic sleeve gastrectomy with a comparable duration of the operation. In robotic learning phase centres, outcomes were within the established benchmarks only for low-risk robotic Roux-en-Y gastric bypass. CONCLUSION: The newly established benchmarks suggest that robotic bariatric surgery may enhance surgical safety compared with laparoscopic bariatric surgery; however, the duration of the operation for robotic Roux-en-Y gastric bypass is longer.
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Cirurgia Bariátrica , Derivação Gástrica , Laparoscopia , Obesidade Mórbida , Procedimentos Cirúrgicos Robóticos , Humanos , Feminino , Idoso , Adulto , Masculino , Derivação Gástrica/efeitos adversos , Obesidade Mórbida/cirurgia , Benchmarking , Estudos Retrospectivos , Cirurgia Bariátrica/efeitos adversos , Laparoscopia/efeitos adversos , Gastrectomia/efeitos adversos , Resultado do TratamentoRESUMO
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.
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Gastroplastia , Gastroplastia/efeitos adversos , Gastroplastia/métodos , Humanos , Obesidade/etiologia , Obesidade/cirurgia , Estudos Prospectivos , Resultado do Tratamento , Redução de PesoRESUMO
BACKGROUND: The field of bariatric surgery has seen peaks and troughs in the types of metabolic procedures performed. Our primary aim was to evaluate bariatric case volumes among fellows enrolled in bariatric Fellowship Council (FC)-accredited programs. Our secondary aim was to assess trends in revisional case volumes. METHODS: We reviewed de-identified FC case logs for all bariatric surgery-accredited programs from 2010 through 2019. The number of primary sleeve gastrectomy, gastric band, gastric bypass, biliopancreatic diversion, and major revisional bariatric surgical procedures (defined as a revision with creation of a new anastomosis) were graphed for each academic year. Fellows were stratified into quartiles based on the number of revisional operations per year and graphed over ten years. Volumes of primary gastric bypass, major revisions, and total anastomotic cases were compared over time using ANOVA with p < 0.05 considered significant. RESULTS: Case volumes for 822 fellows were evaluated. Sleeve gastrectomy had a significant surge in 2010 and plateaued in 2016. The fellows' number of primary gastric bypasses had a non-significant decrease from 84 to 75 cases/fellow from 2010 to 2019. This decrease was offset by a significant increase in major revisional surgery from 8 to 19 cases/fellow. As a result, the number of anastomotic cases did not change significantly over the study time period. Interestingly, as revisional volume has grown, the gap between quartiles of fellowship programs has widened with the 95th percentile growing at a much faster rate than lower quartiles. CONCLUSION: The volume of bariatric procedures performed in the last decade among FC fellows follows similar trends to national data. Major revisional cases have doubled with the most robust growth isolated to a small number of programs. As revisional surgery continues to increase, applicants interested in a comprehensive bariatric practice should seek out training programs that offer strong revisional experience.
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Cirurgia Bariátrica , Desvio Biliopancreático , Derivação Gástrica , Laparoscopia , Obesidade Mórbida , Humanos , Bolsas de Estudo , Reoperação/métodos , Cirurgia Bariátrica/métodos , Derivação Gástrica/métodos , Gastrectomia/métodos , Estudos Retrospectivos , Obesidade Mórbida/cirurgia , Laparoscopia/métodos , Resultado do TratamentoRESUMO
BACKGROUND: Robotic Roux-en-Y gastric bypass (RRYGB) is performed in an increasing number of bariatric centers worldwide. Previous studies have identified a number of demographic and clinical variables as predictors of postoperative complications after laparoscopic Roux-en-Y gastric bypass (LRYGB). Some authors have suggested better early postoperative outcomes after RRYGB compared to LRYGB. The objective of the present study was to assess potential predictors of early postoperative complications after RRYGB. METHODS: A retrospective analysis of two prospective databases containing patients who underwent RRYGB between 2006 and 2019 at two high volumes, accredited bariatric centers was performed. Primary outcome was rate of 30 day postoperative complications. Relevant demographic, clinical and biological variables were entered in a multivariate, logistic regression analysis to identify potential predictors. RESULTS: Data of 1276 patients were analyzed, including 958 female and 318 male patients. Rates of overall and severe 30 day complications were 12.5% (160/1276) and 3.9% (50/1276), respectively. Rate of 30 day reoperations was 1.6% (21/1276). The overall gastrointestinal leak rate was 0.2% (3/1276). Among various demographic, clinical and biological variables, male sex and ASA score >2 were significantly correlated with an increased risk of 30 day complication rates on multivariate analysis (OR 1.68 and 1.67, p=0.005 and 0.005, respectively). CONCLUSION: This study identified male sex and ASA score >2 as independent predictors of early postoperative complications after RRYGB. These data suggest a potentially different risk profile in terms of early postoperative complications after RRYGB compared to LYRGB. The robotic approach might have a benefit for patients traditionally considered to be at higher risk of complications after LRYGB, such as those with BMI >50. The present study was however not designed to assess this hypothesis and larger, prospective studies are necessary to confirm these results.
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Derivação Gástrica , Laparoscopia , Obesidade Mórbida , Procedimentos Cirúrgicos Robóticos , Humanos , Feminino , Masculino , Derivação Gástrica/efeitos adversos , Estudos Prospectivos , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Laparoscopia/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Obesidade Mórbida/cirurgia , Resultado do TratamentoRESUMO
BACKGROUND: Utility and usability of laser speckle contrast imaging (LSCI) in detecting real-time tissue perfusion in robot-assisted surgery (RAS) and laparoscopic surgery are not known. LSCI displays a color heatmap of real-time tissue blood flow by capturing the interference of coherent laser light on red blood cells. LSCI has advantages in perfusion visualization over indocyanine green imaging (ICG) including repeat use on demand, no need for dye, and no latency between injection and display. Herein, we report the first-in-human clinical comparison of a novel device combining proprietary LSCI processing and ICG for real-time perfusion assessment during RAS and laparoscopic surgeries. METHODS: ActivSight™ imaging module is integrated between a standard laparoscopic camera and scope, capable of detecting tissue blood flow via LSCI and ICG in laparoscopic surgery. From November 2020 to July 2021, we studied its use during elective robotic-assisted and laparoscopic cholecystectomies, colorectal, and bariatric surgeries (NCT# 04633512). For RAS, an ancillary laparoscope with ActivSight imaging module was used for LSCI/ICG visualization. We determined safety, usability, and utility of LSCI in RAS vs. laparoscopic surgery using end-user/surgeon human factor testing (Likert scale 1-5) and compared results with two-tailed t tests. RESULTS: 67 patients were included in the study-40 (60%) RAS vs. 27 (40%) laparoscopic surgeries. Patient demographics were similar in both groups. No adverse events to patients and surgeons were observed in both laparoscopic and RAS groups. Use of an ancillary laparoscopic system for LSCI/ICG visualization had minimal impact on usability in RAS as evidenced by surgeon ratings of device usability (set-up 4.2/5 and form-factor 3.8/5). LSCI ability to detect perfusion (97.5% in RAS vs 100% in laparoscopic cases) was comparable in both RAS and laparoscopic cases. CONCLUSIONS: LSCI demonstrates comparable utility and usability in detecting real-time tissue perfusion/blood flow in RAS and laparoscopic surgery.
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Laparoscopia , Procedimentos Cirúrgicos Robóticos , Humanos , Verde de Indocianina , Imagem de Contraste de Manchas a Laser , Laparoscopia/métodos , PerfusãoRESUMO
BACKGROUND: Postoperative morbidity after laparoscopic bariatric surgery is considered higher for patients undergoing revisional versus primary procedures. The objective of this retrospective cohort study was to compare outcomes between patients undergoing primary versus revisional robotically assisted laparoscopic (RAL) Roux-en-Y gastric bypass (RYGB). METHODS: Data of all patients who underwent RAL primary and revisional RYGB between 2009 and 2019 at two accredited, high-volume bariatric surgery centers-the Memorial Hermann - Texas Medical Center, Houston, TX, and the Tower Health, Reading Hospital, Reading, PA, were analyzed. Primary outcomes were early (< 30 days) and overall postoperative complications. Secondary outcomes included intraoperative complications, operative times, conversions to laparotomy, length of hospital stay, early (< 30 days) postoperative readmissions and deaths. RESULTS: Data of 1072 patients were analyzed, including 806 primary and 266 revisional RAL RYGB procedures. Longer operative times (203 versus 154 min, P < 0.001), increased number of readmissions for oral intolerance (10.5% versus 6.7%, P = 0.046) and higher rate of gastrojejunal stricture (6.4% versus 2.7%, P = 0.013) were found in the revisional group. Gastrointestinal leak rates were 0.2% for the primary versus 1.1% for the revisional group (P = 0.101). Early (< 30 days) reoperations rates were 2.2% for the primary versus 1.1% for the revisional group (P = 0.318). There were no statistically significant differences between groups in overall and severe complication rates. CONCLUSION: Patients undergoing RAL primary and revisional RYGB had comparable overall outcomes, with a non-significant higher early complication rate in the revisional group. Despite the study being underpowered to detect differences in specific complication rates, the morbidity seen in the revisional RYGB group remains markedly below literature reports of revisional laparoscopic RYGB and might suggest a benefit of robotic assistance. Further prospective studies are needed to confirm these results.
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Derivação Gástrica , Gastroplastia , Laparoscopia , Obesidade Mórbida , Procedimentos Cirúrgicos Robóticos , Derivação Gástrica/efeitos adversos , Humanos , Obesidade Mórbida/cirurgia , Reoperação , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Resultado do Tratamento , Redução de PesoRESUMO
BACKGROUND AND AIMS: The objective of this study was to examine expert opinion and agreement on the treatment of distinct GERD profiles from surgical and therapeutic endoscopy perspectives. METHODS: We used the RAND/University of California, Los Angeles Appropriateness Method over 6 months (July 2018 to January 2019) to assess the appropriateness of antireflux interventions among foregut surgeons and therapeutic gastroenterologists. Patients with primary atypical or extraesophageal symptoms were not considered. Patient scenarios were grouped according to their symptom response to proton pump inhibitor (PPI) therapy. The primary outcome was appropriateness of an intervention. RESULTS: Antireflux surgery with laparoscopic fundoplication (LF) and magnetic sphincter augmentation (MSA) were ranked as appropriate for all complete and partial PPI responder scenarios. Transoral incisionless fundoplication was ranked as appropriate in complete and partial PPI responders without a hiatal hernia. Radiofrequency energy was not ranked as appropriate for complete or partial responders. There was lack of agreement between surgery and interventional gastroenterology groups on the appropriateness of LF and MSA for PPI nonresponders. Rankings for PPI nonresponders were similar when results from impedance-pH testing on PPI therapy were available, except that LF and MSA were not ranked as appropriate for PPI nonresponders if the impedance-pH study was negative. CONCLUSIONS: This work highlights areas of agreement for invasive therapeutic approaches for GERD and provides impetus for further interdisciplinary collaboration and trials to compare and generate novel and effective treatment approaches and care pathways, including the role of impedance-pH testing in PPI nonresponders.
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Refluxo Gastroesofágico , Laparoscopia , Adulto , Idoso , Endoscopia , Endoscopia Gastrointestinal , Feminino , Fundoplicatura , Refluxo Gastroesofágico/tratamento farmacológico , Refluxo Gastroesofágico/cirurgia , Humanos , Los Angeles , Masculino , Pessoa de Meia-Idade , Inibidores da Bomba de Prótons/uso terapêutico , Resultado do TratamentoRESUMO
BACKGROUND: Laparoscopic repair of recurrent as opposed to primary paraesophageal hernias (PEHs) are historically associated with increased peri-operative complication rates, worsened outcomes, and increased conversion rates. The robotic platform may aid surgeons in these complex revision procedures. The aim of this study was to compare the outcomes of patients undergoing robotic assisted laparoscopic (RAL) repair of recurrent as opposed to primary PEHs. METHODS: Patients undergoing RAL primary and recurrent PEH repairs from 2009 to 2017 at a single institution were reviewed. Demographics, use of mesh, estimated blood loss, intra-operative complications, conversion rates, operative time, rates of esophageal/gastric injury, hospital length of stay, re-admission/re-operation rates, recurrence, dysphagia, gas bloat, and pre- and post-operative proton pump inhibitor (PPI) use were analyzed. Analysis was accomplished using Chi-square test/Fischer's exact test for categorical variables and the Mann-Whitney U test for continuous variables. RESULTS: There were 298 patients who underwent RAL PEH repairs (247 primary, 51 recurrent). They were followed for a median (interquartile range) of 120 (44, 470) days. There were no significant differences in baseline demographics between groups. Patients in the recurrent PEH group had longer operative times, increased use of mesh, and increased length of hospital stay. They were also less likely to undergo fundoplication. There were no significant differences in estimated blood loss, incidence of intra-operative complications, re-admission rates, incidence of post-operative dysphagia and gas bloat, and incidence of post-operative PPI use. There were no conversions to open operative intervention or gastric/esophageal injury/leaks. CONCLUSIONS: Although repair of recurrent PEHs are historically associated with worse outcomes, in this series, RAL recurrent PEH repairs have similar peri-operative and post-operative outcomes as compared to primary PEH repairs. Whether this is secondary to the potential advantages afforded by the robotic platform deserves further study.
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Hérnia Hiatal/cirurgia , Herniorrafia/métodos , Procedimentos Cirúrgicos Robóticos/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Estudos RetrospectivosRESUMO
BACKGROUND: Patients with obesity have a higher risk of trocar site hernia. The objective of the present study was to compare a standard suture passer versus the neoClose® device for port site fascial closure in patients with obesity undergoing laparoscopic bariatric surgery. METHODS: This is a randomized, controlled trial with two parallel arms. Thirty five patients with BMI ≥ 35 kg/m2 and undergoing laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass were randomized to each group. Port site fascial closure for trocars ≥ 10 mm was performed with the neoClose® device in the study group and the standard suture passer in the control group. Primary outcomes were time required to complete closure and intensity of postoperative pain at the fascial closure sites. Secondary outcomes were intraabdominal needle depth and incidence of trocar site hernia. RESULTS: The use of the neoClose® device resulted in shorter closure times (20.2 vs 30.0 s, p = 0.0002), less pain (0.3 vs 0.9, p = 0.002) at port closure sites, and decreased needle depth (3.3 cm vs 5.2 cm, p < 0.0001) compared to the standard suture passer. There was no trocar site hernia at the one-year follow-up in either group. CONCLUSIONS: Use of the neoClose® device resulted in faster fascial closure times, decreased intraoperative needle depth, and decreased postoperative abdominal pain at 1 week as compared to the standard suture passer. These data need to be confirmed on larger cohorts of patients with longer follow-up.
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Gastrectomia/métodos , Derivação Gástrica/métodos , Obesidade/cirurgia , Instrumentos Cirúrgicos/efeitos adversos , Técnicas de Sutura/instrumentação , Adulto , Índice de Massa Corporal , Feminino , Gastrectomia/instrumentação , Derivação Gástrica/instrumentação , Humanos , Hérnia Incisional/etiologia , Laparoscopia , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Estudos Prospectivos , Método Simples-Cego , Técnicas de Sutura/efeitos adversos , SuturasRESUMO
After careful review, the authors have noticed the following mistakes in the article entitled "Trocar site closure with a novel anchor based (neoClose®) system versus standard suture closure: A prospective randomized controlled trial": - Correct closure times are 19.9 seconds (SD 9.9) for the study group and 31.0 seconds (SD 20.1) for the control group (initial incorrect values were 20.2 seconds (SD 10.1) and 30 seconds (SD 19.1) respectively). The new correct P-value is <0.0001 (initial incorrect P-value was 0.0002). - Correct maximal needle depth values are 3.2 cm (SD 0.93) for the study group and 4.9 cm (SD 1.97) for the control group (initial incorrect values were 3.3 cm (SD 0.9) and 5.2 cm (SD 1.6) respectively). P-value remains unchanged at <0.0001. For these two outcomes, some values of control group patients were mistakenly included in the study group. These errors only marginally affected the mean and standard deviation values. Statistical significance of the results was not affected and the conclusions of the study remain unchanged.
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BACKGROUND: The utilization of robotic platforms for general surgery procedures such as hernia repair is growing rapidly in the United States. A limited amount of data are available evaluating operative outcomes in comparison to standard laparoscopic surgery. We completed a retrospective review comparing robotic and laparoscopic ventral hernia repair to provide safety and outcomes data to help design a future prospective trial design. METHODS: A retrospective review of 215 patients undergoing ventral hernia repair (142 robotic and 73 laparoscopic) was completed at two large academic centers. Primary outcome measure evaluated was recurrence. Secondary outcomes included incidence of primary fascial closure, and surgical site occurrences. RESULTS: Propensity for treatment match comparison demonstrated that robotic repair was associated with a decreased incidence of recurrence (2.1 versus 4.2%, p < 0.001) and surgical site occurrence (4.2 versus 18.8%, p < 0.001). This may be because robotic repair was associated with increased incidence of primary fascial closure (77.1 versus 66.7%, p < 0.01). Analysis of baseline patient populations showed that robotic repairs were completed on patients with lower body mass index (28.1 ± 3.6 versus 34.2 ± 6.4, p < 0.001) and fewer comorbidities. CONCLUSIONS: Our retrospective data show that robotic repair was associated with decreased recurrence and surgical site occurrence. However, the differences noted in the patient populations limit the interpretability of these results. As adoption of robotic ventral hernia repair increases, prospective trials need to be designed in order to investigate the efficacy, safety, and cost effectiveness of this evolving technique.
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Hérnia Ventral/cirurgia , Herniorrafia/métodos , Laparoscopia/métodos , Robótica/métodos , Telas Cirúrgicas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND AND AIMS: Many patients who undergo bariatric surgery will experience weight regain and effective strategies are needed to help these patients. A dilated gastrojejunal anastomosis (GJA) has been associated with weight recidivism after Roux-en-Y gastric bypass surgery (RYGB). Endoscopic transoral outlet reduction (TORe) with a full thickness endoscopic suturing device (Overstitch, Apollo Endosurgery, Austin, TX) is a minimally invasive therapeutic option. The primary aim of this project was to examine the safety and long-term efficacy data from three bariatric surgery centers and to conduct a systematic review and meta-analysis of the existing literature. METHODS: Patients who underwent TORe with the Overstitch device from Jan 2013 to Nov 2016 at 3 participating bariatric surgery centers were included in the multicenter analysis. For the systematic review and meta-analysis, a comprehensive search of multiple English databases was conducted. Random effects model was used. RESULTS: 130 consecutive patients across three centers underwent TORe with an endolumenal suturing device. These patients (mean age 47; mean BMI 36.8) had experienced 24.6% weight regain from nadir weight after RYGB. Average weight lost at 6, 12, and 18 months after TORe was 9.31 ± 6.7 kg (N = 84), 7.75 ± 8.4 kg (N = 70), 8 ± 8.8 kg (N = 46) (p < 0.01 for all three time points), respectively. The meta-analysis included 330 patients. The pooled weight lost at 12 months was 8.4 kg (95% CI 6.5-10.3) with no significant heterogeneity across included studies (p = 0.07). Overall, 14% of patients experienced nausea, 18% had pain and 8% required a repeat EGD. No serious adverse events reported. CONCLUSION: When implemented as part of a multidisciplinary intervention, TORe using endolumenal suturing is safe, reproducible, and effective approach to manage weight recidivism after RYGB and should be utilized early in the management algorithm of these patients.
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Endoscopia/métodos , Derivação Gástrica , Obesidade Mórbida/cirurgia , Reoperação/métodos , Técnicas de Sutura , Aumento de Peso , Adulto , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND & AIMS: Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. METHODS: We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. RESULTS: By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). CONCLUSIONS: TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.
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Fundoplicatura/métodos , Refluxo Gastroesofágico/terapia , Omeprazol/uso terapêutico , Inibidores da Bomba de Prótons/uso terapêutico , Adulto , Idoso , Feminino , Humanos , Concentração de Íons de Hidrogênio , Masculino , Pessoa de Meia-Idade , Cuidados Pós-OperatóriosRESUMO
The epidemic of obesity continues to be a major health issue. It is now almost uniform that surgical procedures for weight loss are performed with minimally invasive techniques. This article reviews the literature regarding obesity-related health issues, in particular risk of malignancy, and the application of robotic technology in weight loss surgical procedures. With increasing literature and technology in surgical robotics, its application in the field of bariatric surgery continues to evolve.
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Cirurgia Bariátrica/métodos , Procedimentos Cirúrgicos Robóticos/métodos , Humanos , Neoplasias/etiologia , Neoplasias/prevenção & controle , Obesidade/complicações , Obesidade/cirurgiaRESUMO
BACKGROUND: Preoperative factors predicting symptomatic improvement after transoral fundoplication (TF) in chronic gastroesophageal reflux disease (GERD) patients with persistent symptoms on proton-pump inhibitors (PPIs) therapy have not been elucidated fully. METHODS: Univariate and multivariate logistic regression analyses were performed on data from 158 consecutive patients who underwent TF with the EsophyX device between January 2010 and June 2012 in 14 community centers. Variables included age, gender, body mass index, GERD duration, PPIs therapy duration, presence of hiatal hernia, esophagitis, Hill grade, quality of life scores (QOL) on PPIs, % total time pH < 4, and DeMeester score on reflux testing off PPIs. RESULTS: All patients suffered from typical GERD symptoms. Additionally, 78% (124/158) of patients suffered from atypical symptoms. Six percent (10/158) with recurrent GERD symptoms refractory to PPI therapy underwent revisional procedure (9 laparoscopic Nissen, 1 TF). Median follow-up was 22 (range 10-43) months. For patients with typical symptoms, univariate analyses revealed 4 preoperative factors predictive of successful outcomes: age ≥ 50 [odds ratio (OR) = 2.4, 95% confidence interval (CI) = 1.2-4.8, p = 0.014], GERD Health-related Quality of Life score (GERD-HRQL) ≥ 15 on PPIs (OR = 6.0, CI = 1.2-29.4, p = 0.026, Reflux Symptom Index score > 13 on PPIs (OR = 2.4, CI = 1.1-5.2, p = 0.027), and Gastroesophageal Reflux Symptom Score ≥ 18 on PPIs (OR = 2.6, CI = 1.2-5.8, p = 0.018). Age and GERD-HRQL score remained significant predictors by multivariate analysis. For patients with atypical symptoms, only GERD-HRQL score ≥ 15 on PPIs (OR = 9.9, CI = 0.9-4.6, p = 0.036) was associated with successful outcomes. CONCLUSIONS: Elevated preoperative QOL scores on PPIs and age ≥ 50 were most closely associated with successful outcome of TF in patients with persistent symptoms despite medical therapy.
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Fundoplicatura/métodos , Refluxo Gastroesofágico/cirurgia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Esofagite/complicações , Esôfago/lesões , Feminino , Fundoplicatura/efeitos adversos , Refluxo Gastroesofágico/complicações , Refluxo Gastroesofágico/tratamento farmacológico , Hérnia Hiatal/complicações , Humanos , Laparoscopia , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Prospectivos , Inibidores da Bomba de Prótons/uso terapêutico , Qualidade de Vida , Recidiva , Reoperação , Resultado do Tratamento , Adulto JovemRESUMO
PURPOSE: Endoscopic sleeve gastroplasty (ESG) is a minimally invasive day procedure that the MERIT randomized controlled trial (RCT) has demonstrated to be an effective and safe method of weight loss versus lifestyle modification alone. We sought to evaluate the cost-effectiveness of ESG from the perspective of a US commercial payer in a cohort of adults with class II and class I obesity with diabetes based on this RCT. MATERIALS: We used a Markov modelling approach with BMI group health states and an absorbing death state. Baseline characteristics, utilities, BMI group transition probabilities, and adverse events (AEs) were informed by patient-level data from the MERIT RCT. Mortality was estimated by applying BMI-specific hazard ratios to US general population mortality rates. We used BMI-based health state utilities to reflect the impact of obesity comorbidities and applied disutilities due to ESG AEs. Costs included intervention costs, AE costs, and BMI-based annual direct healthcare costs to account for costs associated with obesity comorbidities. A willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY) was assumed. RESULTS: In our base-case analysis over a 5-year time horizon, ESG was cost-effective versus lifestyle modification alone with an incremental cost-effectiveness ratio of $23,432/QALY. ESG remained cost-effective in all sensitivity analyses we conducted and was dominant in analyses with longer time horizons. CONCLUSION: ESG is a cost-effective treatment option for people living with obesity and should be considered in commercial health plans as an additional treatment option for clinically eligible patients.
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INTRODUCTION: Endoscopy prior to bariatric surgery is not always performed, and in sleeve gastrectomy (SG), the surgical specimen is not always sent for pathological examination. There is limited data on the frequency of clinically significant findings in SG specimens or correlation with preoperative endoscopy. METHODS: We reviewed 426 consecutive SG patients to determine the concordance of preoperative endoscopy findings in patients with clinically significant postoperative pathology. RESULTS: Preoperative endoscopy was performed on 397 patients (93.2%). Three hundred seventy-three patients had preoperative endoscopy and surgical pathology results available. Then, 20/373 (5.4%) patients had potentially significant postoperative pathology, including intestinal metaplasia, autoimmune metaplastic atrophic gastritis (AMAG), gastrointestinal stromal tumors, and/or gastric cancer. The overall incidence of AMAG in the entire cohort was 2.3%. Preoperative gastric biopsies (to include gastric body) identified AMAG in nearly 1/2 of patients. Patients with clinically significant postoperative pathology results had a median [interquartile range] of 3 [3-5] tissue blocks examined as compared to 3 [1-3] for the remainder of the cohort (p < 0.001). CONCLUSION: This is one of the largest studies describing clinically significant postoperative pathology after SG. AMAG, in particular, is of particular importance as it is associated with a 3-fivefold increase in risk for gastric cancer. The incidence of significant postoperative pathology in this population is small but potentially clinically significant and requires validation in larger studies. We recommend wider sampling in preoperative endoscopy (body and antrum), especially in patients being planned for gastric bypass, consideration for routine pathological examination of SG surgical specimens, with careful gross examination and targeted sampling.
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Derivação Gástrica , Gastrite , Laparoscopia , Obesidade Mórbida , Patologia Cirúrgica , Lesões Pré-Cancerosas , Neoplasias Gástricas , Humanos , Endoscopia Gastrointestinal , Gastrectomia/métodos , Gastrite/cirurgia , Laparoscopia/métodos , Obesidade Mórbida/cirurgia , Lesões Pré-Cancerosas/diagnóstico , Estudos Retrospectivos , Neoplasias Gástricas/patologiaRESUMO
Background and study aims Endoscopic sleeve gastroplasty (ESG) is performed in clinical practice by gastroenterologists and bariatric surgeons. Given the increasing regulatory approval and global adoption, we aimed to evaluate real-world outcomes in multidisciplinary practices involving bariatric surgeons and gastroenterologists across the United States. Patients and methods We included adult patients with obesity who underwent ESG from January 2013 to August 2022 in seven academic and private centers in the United States. Patient and procedure characteristics, serious adverse events (SAEs), and weight loss outcomes up to 24 months were analyzed. SPSS (version 29.0) was used for all statistical analyses. Results A total of 1506 patients from seven sites included 235 (15.6%) treated by surgeons and 1271 (84.4%) treated by gastroenterologists. There were no baseline differences between groups. Gastroenterologists used argon plasma coagulation for marking significantly more often than surgeons ( P <0.001). Surgeons placed sutures in the fundus in all instances whereas gastroenterologist placed them in the fundus in less than 1% of the cases ( P <0.001>). Procedure times were significantly different between groups, with surgeons requiring approximately 20 minutes more during the procedure than gastroenterologists ( P <0.001). Percent total body weight loss (%TBWL) and percent responders achieving >10 and >15% TBWL were similar between the two groups at 12, 18, and 24 months. Rates of SAEs were low and similar at 1.7% for surgeons and 2.7% for gastroenterologists ( P >0.05). Conclusions Data from a large US cohort show significant and sustained weight loss with ESG and an excellent safety profile in both bariatric surgery and gastroenterology practices, supporting the scalability of the procedure across practices in a multidisciplinary setting.
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INTRODUCTION: In gastrointestinal surgery, specifically in bariatric surgery, there are many types of fixed bands used for restriction and there are a multitude reasons that might eventually be an impetus for the removal of those bands. Bands consisting of Marlex or non silastic materials can be extremely difficult to remove. Intraoperative complications removing fixed bands include the difficulty in locating the band, inability to remove all of the band, and damage to surrounding structures including gastrotomies. Removal of eroded bands endoscopically may pose less risk. Potentially, forced erosion may be an easier modality than surgery, allowing revision without having to deal with the actual band at the time of definitive revision surgery. METHODS: A retrospective case series developed from a university single institution bariatric practice setting was utilized. Endpoints for the study include success of band removal, complications, length of time the stent was present, and the type of stent. RESULTS: A total of 15 consecutive cases utilizing endoscopic stenting to actively induce fixed gastric band erosion for subsequent endoscopic removal were reviewed. There was an 87 % success rate in complete band removal with partial removal of the remaining bands that resolved the patient's symptoms. A complication rate of 27 % was recorded among the 15 patients, consisting of pain and/or nausea and vomiting. The mean time period of the placement of the stent prior to removal or attempted removal was 16.3 days. CONCLUSION: Endoscopic forced erosion of fixed gastric bands is feasible, safe, and may offer an advantage over laparoscopic removal. This technique is especially applicable for gastric obstruction from fixed bands, prior to large and definitive revision surgeries, or anticipated hostile anatomy that might preclude an abdominal operation altogether.