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Rodriguez L.,CCO Obesidad | Rodriguez P.,CCO Obesidad | Gomez B.,CCO Obesidad | Ayala J.C.,Clinic Indisa | And 5 more authors.
Endoscopy | Year: 2013

Background and study aims: In patients with gastroesophageal reflux disease (GERD), temporary electrical stimulation of the lower esophageal sphincter (LES) increases LES pressure without interference with LES relaxation. The aim of the current study was to investigate the safety and efficacy of long term LES electrical stimulation therapy (LES-EST), using a permanently implanted stimulator for the treatment of GERD. Patients and methods: Patients with GERD who were at least partially responsive to proton pump inhibitors (PPIs) and who had hiatal hernia of ≤ 3 cm and esophagitis of Los Angeles Grade A, B, or C were included in the study. Stimulation electrodes were placed in the LES and a pulse generator (EndoStim LES Stimulation System; EndoStim BV, The Hague, The Netherlands) was implanted laparoscopically. LES stimulation was delivered at 20 Hz, 215 μs, 3 - 8 mA in multiple 30-minute sessions. Patients were evaluated at follow-up using the GERD Health-Related Quality of Life (HRQL) questionnaire, daily symptom and medication diaries, the SF-12 Health Survey, esophageal pH testing, and high resolution manometry. Results: A total of 24 patients (mean age 53 ± 12 years; 14 men) were implanted and 23 completed the 12-month evaluation. No serious implantation or stimulation-related adverse affects or sensations were reported. Median composite GERD-HRQL score at 12 months was 2.0 (interquartile range [IQR] 0 - 3.0), which was significantly better than baseline scores both on PPI therapy (median 9.0, IQR 6.0 - 10.0; P = 0.002) and off PPIs (median 23.5, IQR 21 - 25.75; P < 0.001). The median percentage of the 24-hour period with esophageal pH < 4.0 at baseline was 10.1 % (IQR 7.7 - 15.5), which was reduced to 3.3 % (1.8 - 6.9) at 12 months (P < 0.001), with 69 % of patients showing either normalization or > 50 % improvement in their distal esophageal pH. At 12 months, 96 % of patients (22/23) were completely off PPI medication. Conclusion: During the long term follow-up of 12 months, LES - EST was safe and effective for the treatment of GERD. There was a significant and sustained improvement in GERD symptoms, reduction in esophageal acid exposure with elimination of daily PPI usage, and no stimulation-related adverse effects. © Georg Thieme Verlag KG Stuttgart, New York.


Ramos A.,Gastro Obeso Center | Neto M.G.,Gastro Obeso Center | Galvao M.,Gastro Obeso Center | Evangelista L.F.,Federal University of Pernambuco | And 2 more authors.
Obesity Surgery | Year: 2010

Background Vertical sleeve gastrectomy (VSG) is a surgical technique that involves resection of a significant portion of the stomach. This surgery is sometimes associated with gastric leaks, which can be difficult to treat. The present study reports findings from laparoscopic greater curvature plication (LGCP), which is an alternative bariatric procedure similar to VSG but without the need for gastric resection. Methods A prospective study was carried out, following LGCP in 42 morbidly obese patients (30 female/12 male) with a mean age of 33.5 years (23 to 48) and mean BMI of 41 kg/m2 (35 to 46). Through a five-port approach, the stomach was reduced by dissecting the greater omentum and short gastric vessels, as in VSG, and the greater curvature was then invaginated using multiple rows of nonabsorbable suture performed over a 32-Fr bougie to ensure a patent lumen. Results All procedures were completed laparoscopically. Mean operative time was 50 min (40 to 100 min) and mean hospital stay was 36 h (24 to 96). Patients returned to their regular activities at an average of 7 days (4 to 13) following surgery. No intra-operative complications occurred. All patients experienced excess weight loss (EWL) of at least 20% after 1 month. Mean EWL was 62% (45% to 77%) in nine patients after 18 months. There has been no record of weight regain in any patient to date. Conclusions LGCP is feasible, safe, and effective for at least 18 months when performed on morbidly obese patients. Longer follow-up and prospective comparative trials are needed. © Springer Science+Business Media, LLC 2010.


Falcao M.,Federal University of Pernambuco | Campos J.M.,Federal University of Pernambuco | Neto M.G.,Gastro Obeso Center | Ramos A.,Gastro Obeso Center | And 5 more authors.
Obesity Surgery | Year: 2012

Roux-en-Y gastric bypass (RYGB) is an effective treatment for morbid obesity. However, it may lead to diseases of the bilio-pancreatic tract. We evaluated transgastric endoscopic retrograde cholangiopancreatography (ERCP) for managing common biliary tract diseases in patients that underwent RYGB treatment for obesity. This prospective study was conducted between 2003 and 2010 at three medical institutions. We included 23 patients with a mean body mass index of 28.2 kg/m 2 after RYGB treatment. ERCP was performed in all patients to manage biliary tract diseases within 9 to 27 months (mean 16.3 months) of RYGB surgery. The gastrotomy was conducted through the anterior wall of the greater curve of the excluded stomach. A duodenoscope was introduced in the direction of the ostomy to perform the ERCP with sphincterotomy. All patients underwent an ERCP and papillotomy without incident. Ten patients underwent simultaneous cholecystectomy. A total of 17 gallstones were removed. The average gastrotomy duration was 92.69 min; the average hospital stay was 2 days. One patient had mild acute pancreatitis that resolved clinically. There was no mortality. Laparoscopy-assisted transgastric ERCP was feasible and safe for patients after RYGB. The necessary equipment is available in most bariatric surgery centers. © 2012 Springer Science + Business Media, LLC.


De Sa V.C.T.,Federal University of Pernambuco | Ferraz A.A.,Federal University of Pernambuco | Campos J.M.,Federal University of Pernambuco | Ramos A.C.,Gastro Obeso Center | And 2 more authors.
Obesity Surgery | Year: 2011

Background Type 2 diabetes mellitus (T2DM) and class I obesity, which are pandemics of considerable socioeconomic importance, require new treatment modalities due to inadequate control through normal clinical conduct. The aim of the present study was to assess the efficacy and safety of Roux-en-Y gastric bypass (RYGB) in the control of T2DM in patients with a body mass index (BMI) of 30 to 35 kg/m2. Methods An observational, retrospective study was carried out at the Universidade Federal de Pernambuco-Brazil. Between 2002 and 2008, 27 patients were submitted to RYGB for the treatment of uncontrolled T2DM, with a mean follow-up period of 20 months. An assessment was performed of the complete resolution of T2DM [HbA1c< 6%/fasting plasma glucose (FPG)<100 mg/dL/no diabetes medication] and glycemic control. The ethics committee of the university approved the study. Results RYGB led to the following results: (1) 23% weight reduction (p<0.001), BMI stabilized at 25.6 kg/m2 in a mean of 12 months; (2) 46% reduction in glycemia and 27% reduction in HbA1c (p<0.001); (3) 100% improvement in glycemia and 48% resolution of T2DM; (4) glycemic control was 74% without medication and 93% with medication and five patients required medication in addition to RYGB; (5) mean current FPG is 93 mg/dL and HbA1c is 6%; and (6) there were no severe complications or deaths. Conclusions RYGB is a safe and effective option in the treatment of uncompensated T2DM associated to class I obesity. © Springer Science + Business Media, LLC 2009.


Rodriguez L.,Centro Clinico Of Obesidad Cco | Rodriguez P.,Centro Clinico Of Obesidad Cco | Gomez B.,Centro Clinico Of Obesidad Cco | Ayala J.C.,Clinica Indisa | And 4 more authors.
Surgical Endoscopy and Other Interventional Techniques | Year: 2013

Background: Electrical stimulation of the lower esophageal sphincter (LES) improves LES pressure without interfering with LES relaxation. The aim of this open-label pilot trial was to evaluate the safety and efficacy of long-term LES stimulation using a permanently implanted LES stimulator in patients with gastroesophageal reflux disease (GERD). Methods: GERD patients who were at least partially responsive to proton pump inhibitors (PPI) with abnormal esophageal pH, hiatal hernia ≤3 cm, and esophagitis ≤LA grade C were included. Bipolar stitch electrodes were placed in the LES and an IPG was placed in a subcutaneous pocket. Electrical stimulation was delivered at 20 Hz, 215 μs, 3-8 mA in 30 min sessions. The number and timing of sessions was tailored to each patient's GERD profile. Patients were evaluated using GERD-HRQL, daily symptom and medication diaries, SF-12, esophageal pH, and high-resolution manometry. Results: 24 patients (mean age = 53 years, SD = 12 years; 14 men) were implanted; 23 completed their 6-month evaluation. Median GERD-HRQL scores at 6 months was 2.0 (IQR = 0-5.5) and was significantly better than both baseline on-PPI [9.0 (range = 6.0-10.0); p < 0.001] and off-PPI [23 (21-25); p < 0.001] GERD-HRQL. Median% 24-h esophageal pH < 4.0 at baseline was 10.1 and improved to 5.1 at 6 months (p < 0.001). At their 6-month follow-up, 91 % (21/23) of the patients were off PPI and had significantly better median GERD-HRQL on LES stimulation compared to their on-PPI GERD-HRQL at baseline (9.0 vs. 2.0; p < 0.001). There were no unanticipated implantation- or stimulation-related adverse events or untoward sensation due to stimulation. There were no reports of treatment-related dysphagia, and manometric swallow was also unaffected. Conclusions: Electrical stimulation of the LES is safe and effective for treating GERD. There is a significant and sustained improvement in GERD symptoms, esophageal pH, and reduction in PPI usage without any side effects with the therapy. Furthermore, the therapy can be optimized to address an individual patient's disease. © 2012 Springer Science+Business Media, LLC.


Rodriguez L.,Indisa Hospital | Rodriguez P.,Indisa Hospital | Neto M.G.,Gastro Obeso Center | Ayala J.C.,Indisa Hospital | And 4 more authors.
Neurogastroenterology and Motility | Year: 2012

Background Electrical stimulation (ES) of the lower esophageal sphincter (LES) increases resting LES pressure (LESP) in animal models. Our aims were to evaluate the safety of such stimulation in humans, and test the hypothesis that ES increases resting LESP in patients with gastroesophageal reflux disease (GERD). Methods A total of 10 subjects (nine female patients, mean age 52.6years), with symptoms of GERD responsive to PPIs, low resting LES pressure, and abnormal 24-h intraesophageal pH test were enrolled. Those with hiatal hernia >2cm and/or esophagitis >Los Angeles Grade B were excluded. Bipolar stitch electrodes were placed longitudinally in the LES during an elective laparoscopic cholecystectomy, secured by a clip and exteriorized through the abdominal wall. Following recovery, an external pulse generator delivered two types of stimulation for periods of 30min: (i) low energy stimulation; pulse width of 200μs, frequency of 20Hz and current of 5-15mA (current was increased up to 15mA if LESP was less than 15mmHg), and (ii) high energy stimulation; pulse width of 375ms, frequency of 6cpm, and current 5mA. Resting LESP, amplitude of esophageal contractions and residual LESP in response to swallows were assessed before and after stimulation. Symptoms of chest pain, abdominal pain, and dysphagia were recorded before, during, and after stimulation and 7-days after stimulation. Continuous cardiac monitoring was performed during and after stimulation. Key Results All patients were successfully implanted nine subjects received high frequency, low energy, and four subjects received low frequency, high energy stimulation. Both types of stimulation significantly increased resting LESP: from 8.6mmHg (95% CI 4.1-13.1) to 16.6mmHg (95% CI 10.8-19.2), P<0.001 with low energy stimulation and from 9.2mmHg (95% CI 2.0-16.3) to 16.5mmHg (95% CI 2.7-30.1), P=0.03 with high energy stimulation. Neither type of stimulation affected the amplitude of esophageal peristalsis or residual LESP. No subject complained of dysphagia. One subject had retrosternal discomfort with stimulation at15mA that was not experienced with stimulation at 13mA. There were no adverse events or any cardiac rhythm abnormalities with either type of stimulation. Conclusions & Inferences Short-term stimulation of the LES in patients with GERD significantly increases resting LESP without affecting esophageal peristalsis or LES relaxation. Electrical stimulation of the LES may offer a novel therapy for patients with GERD. © 2012 Blackwell Publishing Ltd.


Abdelbaki T.N.,Case Western Reserve University | Huang C.-K.,E Da Hospital | Ramos A.,Gastro Obeso Center | Neto M.G.,Gastro Obeso Center | And 2 more authors.
Obesity Surgery | Year: 2012

Background: Gastric plication is a new bariatric procedure. Controversies exist regarding this emerging surgery. We herein present a comprehensive review of the literature regarding gastric plication approach. Methods: Advanced Pub Med search combining the MeSH terms Gastric plication, OR Gastric greater curvature plication yielded 213 abstracts. Abstracts were screened for articles in English and articles on human subjects yielding 130. Further searches revealed 121 titles to be unrelated to gastric plication. The remaining nine abstracts were analyzed for their full texts. Two articles were excluded because, one was a commentary on another article, and the other was a released ASMBS policy on gastric plication. In the end, there were seven articles published on gastric plication. Results: A total of 307 patients had undergone gastric plication. The mean operative time range was 40 to 150 min. The median length of hospital stay ranged between 1.3 and 1.9 days. In respect to excess weight loss (EWL), at 6 months, it ranged from 54 to 51 %, while at 12 months 67-53.4 %. The longest follow-up was 3 years with a mean of 57 % EWL. Conclusion: Laparoscopic gastric plication is still in its infancy. Prospective randomized studies comparing gastric plication to other well established bariatric procedures are needed to prove the reliability and metabolic effectiveness of such new procedure. © 2012 Springer Science + Business Media, LLC.


Lopez-Nava G.,Madrid Sanchinarro University Hospital | Galvao M.P.,Gastro Obeso Center | Da Bautista-Castano I.,Madrid Sanchinarro University Hospital | Jimenez A.,Madrid Sanchinarro University Hospital | And 2 more authors.
Endoscopy | Year: 2015

Background and study aims: Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations achieved by surgical sleeve gastrectomy. The objective of this study was to evaluate endoscopic sleeve gastroplasty. Patients and methods: This was a prospective, single-center study of 20 patients who underwent flexible endoscopic suturing for endoluminal gastric volume reduction. A multidisciplinary team provided postprocedure care. Patient status and weight were recorded at baseline, and at 1, 3, and 6 months after the procedure. Results: There were no adverse events and all patients were discharged in less than 24 hours. Baseline mean body mass index was 38.5 kg/m2, and mean age was 45.8 years. Initial body weight (108.5 ± 14.9 kg) was significantly reduced. Following the procedure, the mean body weight reduction was 8.2 ± 2.5 kg at 1 month (% of initial weight loss 7.6%; P<0.05), 13.6 ± 4.8 kg at 3 months (12.4% weight loss; P<0.05), and 19.3± 8.9 kg at 6 months (17.8% weight loss; P<0.05). Conclusion: Endoscopic sleeve gastroplasty can be effective for the treatment of patients with obesity. © Georg Thieme Verlag KG.


Cohen R.V.,Hospital Oswaldo Cruz | Neto M.G.,Gastro Obeso Center | Correa J.L.,Hospital Oswaldo Cruz | Sakai P.,Hospital Oswaldo Cruz | And 6 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2013

Context: The duodenal-jejunal bypass liner (DJBL) is a device that mimics the intestinal portion of gastric bypass surgery and has beenshownto improve glucose metabolism rapidly in obese subjects with type 2 diabetes (T2DM). Objective: To assess the safety of the DJBL and to evaluate its potential to affect glycemic control beneficially in subjects with T2DM who were not morbidly obese. Patients and Design: Adult men and women with T2DM of ≤10 years' duration with hemoglobin A1c (HbA1c) ≥7.5% and ≤10% and having a body mass index ≥26 to ≤50 kg/m2 were enrolled in this prospective, 52-week, single-center, open-label clinical study. Main Outcome Measures: Adverse events and changes in body weight, fasting plasma glucose (FPG) levels, and HbA1c levels. Results: Sixteen of 20 subjects implanted with the DJBL completed the 1-year study (mean body mass index = 30.0 ± 3.6, mean ± SD). Gastrointestinal disorders were reported by 13 subjects, and metabolic or nutritional disorders occurred in 14 subjects. FPG levels dropped from 207 ± 61 mg/dL at baseline to 139 ± 37 mg/dL at 1 week and remained low throughout the study. Mean body weight also declined, but the change in body weight was not significantly associated with change in FPG at 52 weeks. HbA1c declined from 8.7 ± 0.9% at baseline to 7.5 ± 1.6% at week 52. Conclusions: The improvements in glycemic status were observed at 1 year in moderately obese subjects with T2DM, suggesting that the DJBL may represent an effective adjuvant to standard medical therapy of T2DM in this population. Copyright © 2013 by The Endocrine Society.


Lopez-Nava G.,Madrid Sanchinarro University Hospital | Galvao M.P.,Gastro Obeso Center | Bautista-Castano I.,Madrid Sanchinarro University Hospital | Jimenez-Banos A.,Madrid Sanchinarro University Hospital | Fernandez-Corbelle J.P.,Madrid Sanchinarro University Hospital
Obesity Surgery | Year: 2015

Background: Primary endoscopic weight loss therapies are of interest for access, simplicity, and economy. The objective of this manuscript is to describe the endoscopic sleeve gastroplasty used in 50 patients. Methods: 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 are admitted and observed, with discharge planned within 24 h. Post-procedure outpatient care includes diet instruction with intensive follow-up by a multidisciplinary team. Voluntary oral contrast and endoscopy studies are scheduled to assess the gastroplasty at 3, 6, and 12 months. Results: The technique was applied in 50 patients (13 men) with an average body mass index (BMI) of 37.7 kg/m2 (range 30–47) with 13 having reached 1 year. Procedure duration averaged 66 min during which six to eight sutures on average were placed. All patients were discharged in less than 24 h. There were no major intra-procedural, early, or delayed adverse events. Weight loss parameters were satisfactory, mean BMI changes from 37.7 ± 4.6 to 30.9 ± 5.1 kg/m2 at 1 year, and mean %TBWL was 19.0 ± 10.8. Oral contrast studies and endoscopy revealed sleeve gastroplasty configuration at least until 1 year of follow-up. Conclusion: Endoscopic sleeve gastroplasty is a safe, effective, and reproducible primary weight loss technique. © 2015, Springer Science+Business Media New York.

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