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Annals of Surgery | 2013

Can Diabetes Be Surgically Cured?: Long-Term Metabolic Effects of Bariatric Surgery in Obese Patients with Type 2 Diabetes Mellitus

Stacy A. Brethauer; Ali Aminian; Héctor Romero-Talamás; Esam Batayyah; Jennifer Mackey; Laurence Kennedy; Sangeeta R. Kashyap; John P. Kirwan; Tomasz Rogula; Matthew Kroh; Bipan Chand; Philip R. Schauer

Objective: Evaluate the long-term effects of bariatric surgery on type 2 diabetes (T2DM) remission and metabolic risk factors. Background: Although the impressive antidiabetic effects of bariatric surgery have been shown in short- and medium-term studies, the durability of these effects is uncertain. Specifically, long-term remission rates following bariatric surgery are largely unknown. Methods: Clinical outcomes of 217 patients with T2DM who underwent bariatric surgery between 2004 and 2007 and had at least 5-year follow-up were assessed. Complete remission was defined as glycated hemoglobin (A1C) less than 6% and fasting blood glucose (FBG) less than 100 mg/dL off diabetic medications. Changes in other metabolic comorbidities, including hypertension, dyslipidemia, and diabetic nephropathy, were assessed. Results: At a median follow-up of 6 years (range: 5–9) after surgery (Roux-en-Y gastric bypass, n = 162; gastric banding, n = 32; sleeve gastrectomy, n = 23), a mean excess weight loss (EWL) of 55% was associated with mean reductions in A1C from 7.5% ± 1.5% to 6.5% ± 1.2% (P < 0.001) and FBG from 155.9 ± 59.5 mg/dL to 114.8 ± 40.2 mg/dL (P < 0.001). Long-term complete and partial remission rates were 24% and 26%, respectively, whereas 34% improved (>1% decrease in A1C without remission) from baseline and 16% remained unchanged. Shorter duration of T2DM (P < 0.001) and higher long-term EWL (P = 0.006) predicted long-term remission. Recurrence of T2DM after initial remission occurred in 19% and was associated with longer duration of T2DM (P = 0.03), less EWL (P = 0.02), and weight regain (P = 0.015). Long-term control rates of low high-density lipoprotein, high low-density lipoprotein, high triglyceridemia, and hypertension were 73%, 72%, 80%, and 62%, respectively. Diabetic nephropathy regressed (53%) or stabilized (47%). Conclusions: Bariatric surgery can induce a significant and sustainable remission and improvement of T2DM and other metabolic risk factors in severely obese patients. Surgical intervention within 5 years of diagnosis is associated with a high rate of long-term remission.


Obesity Surgery | 2005

The effects of acute preoperative weight loss on laparoscopic Roux-en-Y gastric bypass.

Rockson C. Liu; Adheesh A. Sabnis; Celeste Forsyth; Bipan Chand

Background: Minimal acute pre-operative weight loss significantly reduces liver size and intra-abdominal adipose tissue. We hypothesize that these changes will reduce intra-operative complications and reduce the difficulty of laparoscopic Roux-en-Y gastric bypass (LRYGBP). Methods: This is a retrospective chart review of consecutive patients who had undergone isolated LRYGBP between July 2003 and March 2005. All patients participated in our institutions medically supervised Weight Management Program before surgery. Results: 48 patients (Weight Loss Group) had an average percent loss of excess weight (%EWL) of 4.6; whereas 47 patients (No Weight Loss Group) gained an average of 4.8% of excess weight over an average period of 2.4 and 3 months (P=0.09), respectively. There were no differences between the two groups in age, gender, ASA class, co-morbidities, or BMI at operation. The Weight Loss Group had less intra-operative blood loss (102 vs 72 ml, P=.03). The surgeon was also less likely to report an enlarged liver in the Weight Loss Group (P=.02). Finally, the operation was less likely to deviate from the standard LRYGBP when patients lost weight (P=.02). No differences were seen in operative time, length of hospital stay, wound infections, or major complications. Conclusion: Acute preoperative weight loss is associated with less intra-operative blood loss and reduces the need for intraoperative deviation from the standard LRYGBP. A larger series with a greater reduction in excess weight is necessary to determine the maximal benefits of acute preoperative weight loss.


Surgical Endoscopy and Other Interventional Techniques | 2007

New applications for endoscopy: the emerging field of endoluminal and transgastric bariatric surgery

Phillip R. Schauer; Bipan Chand; Stacy A. Brethauer

Endoluminal and transgastric procedures are evolving concepts that combine the skills and techniques of flexible endoscopy with minimally invasive surgery. Precisely how this technology and skill set will be applied in the field of general surgery is not yet known, but the treatment of obesity with an endoluminal or transgastric procedure holds great promise. As the demand for bariatric surgery increases, efforts will be directed toward developing less morbid and less costly treatment options that can provide substantial weight loss and resolution of comorbid conditions. Natural orifice bariatric procedures may include short-term weight loss in preparation for a definitive laparoscopic procedure, revisional procedures to reduce stoma or pouch size or repair fistulas, or primary therapy that provides durable weight loss. The latter application will undoubtedly appeal to patients and referring physicians if it can be performed as an outpatient procedure with significantly less morbidity than a laparoscopic procedure. Early preclinical and clinical work has been published in this area, but many technical obstacles must be overcome before a primary endoluminal or transgastric bariatric procedure can be offered. This article reviews the endoluminal and transgastric technology currently available, the endoluminal procedures currently performed, and the future of these technologies with respect to bariatric surgery.


Surgery for Obesity and Related Diseases | 2009

Obesity is associated with increased prevalence and severity of pelvic floor disorders in women considering bariatric surgery

Chi Chiung Grace Chen; Patrick Gatmaitan; Sidney Koepp; Matthew D. Barber; Bipan Chand; Philip R. Schauer; Stacy A. Brethauer

BACKGROUND Although an association between obesity and urinary incontinence (UI) has been reported, the association between obesity and other PFDs is less clear. The aim of this study was to determine the prevalence of pelvic floor disorders (PFDs), including stress urinary incontinence (SUI), urge urinary incontinence (UUI), pelvic organ prolapse (POP), and anal incontinence (AI), in obese women contemplating bariatric surgery compared with nonobese subjects at a tertiary care referral hospital. METHODS From September 2006 to December 2007, obese women contemplating bariatric surgery and nonobese women from general gynecology clinic completed a validated screening questionnaire for PFDs, the Sandvik urinary incontinence severity index, and the Rockwood fecal incontinence severity index. RESULTS A total of 217 obese (mean body mass index of 50 +/- 10 kg/m(2)) and 210 nonobese controls (mean body mass index 23 +/- 3 kg/m(2)) were screened. The presence of any PFD occurred in 159 patients (75%) in the obese group compared with 89 nonobese patients (44%; P <.0001). More obese patients experienced SUI, UUI, and AI, but not POP. Obese patients also had more severe UI and AI. Obesity remained a significant risk factor for UI and AI, even after adjusting for baseline differences in demographics and medical conditions, with an adjusted odds ratio of 4.1 (95% confidence interval 2.3-7.8) and 2.1 (95% confidence interval 1.1-4.1), respectively. CONCLUSION The prevalence of PFDs, including SUI, UUI, and all forms of AI, was greater in the obese and morbidly obese women contemplating bariatric surgery. Obesity was also associated with an increased severity of UI and AI. Obesity appears to confer a fourfold and twofold increased risk of UI and AI, respectively.


Gastrointestinal Endoscopy | 2003

Mucosal apposition in endoscopic suturing

Joshua Felsher; Houssam Farres; Bipan Chand; Carol Farver; Jeffrey L. Ponsky

BACKGROUND The proliferation of minimally invasive surgery has led to the development of numerous entirely intracorporeal endoscopic suturing techniques. These techniques allow for simple apposition of the GI mucosa. It is yet to be determined whether this results in long-term mucosal apposition. This study was designed to determine whether the current techniques of endoscopic suturing necessitate preliminary mucosal manipulation. METHODS Seven dogs underwent laparotomy and gastrotomy to expose the proximal gastric mucosa. Three different suturing techniques were used to appose adjacent tissue folds: simple mucosal apposition, electrosurgical mucosal ablation before closure, and mucosal resection before closure. Apposition sites were scored histologically, based on tissue healing after 2 weeks. RESULTS Mucosal ablation before tissue apposition resulted in significantly greater healing compared with simple apposition and resulted in histologic scoring similar to that for mucosal resection. The mean histologic score after ablation was 1.5, vs. 1.25 after mucosal resection, and 0.9 for sites closed simply (p=0.02). CONCLUSIONS Endoscopic suturing techniques may one day offer an alternative to surgical treatment in the management of numerous GI conditions. As this modality evolves, the incorporation of target tissue ablation or mucosal resection before tissue apposition requires consideration. Human studies evaluating the safety and long-term efficacy of these modifications are necessary.


Surgery for Obesity and Related Diseases | 2011

Transoral gastric volume reduction as intervention for weight management: 12-month follow-up of TRIM trial

Stacy A. Brethauer; Bipan Chand; Philip R. Schauer; Christopher C. Thompson

BACKGROUND The aim of the present pilot study was to evaluate the safety and weight loss efficacy of endoscopic transoral gastric volume reduction using an endoscopic suturing system. METHODS Patients with a body mass index (BMI) of 30-45 kg/m(2) were enrolled in the present institutional review board-approved study. Anterior to posterior gastric plications were placed in the gastric fundus and body using the suturing device. The endpoints were procedure time, adverse events, weight loss, and endoscopic findings at 1, 6, and 12 months after the procedure. The nominal P values are presented. RESULTS A total of 18 patients underwent the procedure (9 at each site). The mean age and BMI was 40 years and 38 kg/m(2), respectively. The average number of plications placed per patient was 6, and the mean procedure time was 2.1 hours (range 1.5-2.8). At 12 months of follow-up (n = 14), decreases in the mean weight (-11.0 ± 10.0 kg, P = .0006), mean BMI (-4.0 ± 3.5 kg/m(2), P = .0006), and mean waist circumference (-12.6 ± 9.5 cm, P = .0004) were observed. The mean excess weight loss at 12 months was 27.7% ± 21.9%. The proportion of patients with an EWL of ≥ 20% or ≥ 30% was 57% and 50%, respectively. The mean systolic and diastolic blood pressure decreased by 15.2 mm Hg (P = .0012) and 9.7 mm Hg (P = .0051), respectively. No device- or procedure-related serious adverse events. Endoscopy at 12 months of follow-up showed partial or complete release of plications in 13 patients. CONCLUSION Transoral gastric volume reduction procedure using the RESTORe Suturing System device proved to be safe and well tolerated. Procedural technical success was achieved for all subjects. Modest decreases in weight, BMI, and waist circumference were observed, as was a decline in the frequency of hypertension. Despite some overall positive clinical findings, the plications were not durable, and the effects of the procedure varied widely among the study participants. Additional research is needed to provide a more reproducible and durable effect.


Surgery for Obesity and Related Diseases | 2013

Bariatric surgery in patients with liver cirrhosis

Hideharu Shimizu; Viet Phuong; Munique Maia; Matthew Kroh; Bipan Chand; Philip R. Schauer; Stacy A. Brethauer

BACKGROUND Data regarding the management of bariatric patients with cirrhosis are scarce, and there is no strong evidence that supports a specific approach for this group of patients. The aim of this study was to review our experience with cirrhotic patients undergoing bariatric surgery. METHODS A prospectively maintained database was reviewed to assess the outcomes of bariatric surgery for patients with known cirrhosis and for patients with cirrhosis discovered at surgery (unknown cirrhosis). RESULTS From April 2004 to September 2011, 23 patients (12 with known cirrhosis and 11 with unknown cirrhosis) met inclusion criteria. There were 14 females and 9 males with a mean age of 51.5 ± 8.3 and a mean body mass index of 48.2 ± 8.6 kg/m2. Child-Pugh classes were A (n = 22) and B (n = 1). Patients had a high frequency of diabetes (83%), dyslipidemia (61%), and hypertension (83%). Procedures performed were laparoscopic Roux-en-Y gastric bypass (LRYGB) (n = 14), laparoscopic sleeve gastrectomy (LSG) (n = 8), and laparoscopic adjustable gastric banding (n = 1). Two patients underwent LSG successfully after transjugular intrahepatic portosystemic shunt. Mean length of hospital stay was 4.3 ± 2.7 days. Complications developed in 8 patients. One patient died of unknown cause 9 months after surgery. No patients had liver decompensation after surgery. The patients lost 67.4% ± 30.9% of their excess weight at 12 months follow-up and 67.7% ± 24.8% at 37 months follow-up. CONCLUSION LRYGB and LSG can be performed without prohibitive complication rates in carefully selected patients with cirrhosis. In our experience, bariatric patients with cirrhosis achieved excellent weight loss and improvement in obesity-related co-morbidities.


Archive | 2007

Laparoscopic Sleeve Gastrectomy

Vadim Sherman; Stacy A. Brethauer; Bipan Chand; Philip R. Schauer

With the current epidemic of obesity spreading worldwide, surgical weight loss has been shown to be the most effective treatment. However, severely obese patients, that is, those with a body mass index (BMI) over 60, have an increased number of comorbid conditions and thus an increased operative risk. Several studies have demonstrated an increased rate of complications with weightloss surgery in this group of patients with approximately two to three times greater risk of morbidity and mortality than the morbidly obese patient with a BMI less than 60 (1, 2, 3).


Medical Principles and Practice | 2009

Stricture Rate after Laparoscopic Roux-en-Y Gastric Bypass with a 21-mm Circular Stapler: The Cleveland Clinic Experience

Fahad Alasfar; Adheesh A. Sabnis; Rockson C. Liu; Bipan Chand

Objective: The objectives of this study were to report the incidence of gastrojejunal anastomic strictures that occurred in laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery and to determine the time course of presentation, associated perioperative factors, and response to balloon dilation. Subjects and Methods: All 126 patients who underwent LRYGB at the Cleveland Clinic Foundation between July 2003 and February 2005 were included. We utilized a transoral 21-mm circular stapler for the gastrojejunostomy. Patients with symptoms of anastomotic strictures underwent upper endoscopy by one surgeon (B.C.). A stricture was defined by the inability to pass a 10-mm gastroscope through the anastomosis. Balloon dilation was performed to 12 mm. Records were analyzed retrospectively and statistical analysis including Pearson χ2 statistics, Fisher’s exact test and Student’s t test were used when appropriate. Results: Symptomatic anastomotic strictures occurred in 29 (23%) patients. All patients presented with nausea, vomiting and dysphagia. The median time to diagnosis was 52 days (25–309 days). Symptoms resolved after one dilation in 25 (86%) of patients. Two and three dilations were required in 1 (3.5%) and 3 (10.5%) of patients, respectively. No patients had complications or required more than 3 dilations. Age, preoperative body mass index (BMI), and intraoperative blood loss did not correlate with stricture formation. Although nonsteroidal anti-inflammatory drugs were used by 46 (41%) of patients after surgery, there was no correlation with stricture formation. Conclusion: Symptomatic anastomotic strictures developed in nearly a quarter of patients who underwent LRYGB utilizing a transoral 21-mm circular stapled gastrojejunal anastomosis. A single endoscopic balloon dilation was usually adequate. Strictures were not predicted by perioperative factors.


Surgery for Obesity and Related Diseases | 2010

Transoral gastric volume reduction for weight management: technique and feasibility in 18 patients

Stacy A. Brethauer; Bipan Chand; Philip R. Schauer; Christopher C. Thompson

BACKGROUND Endoluminal suturing to reduce the gastric volume might provide an additional option for the treatment of obesity. Potential advantages of a nonoperative endoluminal intervention include less pain, the ability to perform it as an outpatient procedure, and a high level of patient acceptance. The purpose of the present pilot study was to demonstrate the feasibility and procedural safety of transoral gastric volume reduction (TRIM procedure) using the Restore Suturing System in patients with a body mass index of 30-45 kg/m(2). Successful completion of the procedure and adverse events were evaluated at academic/university hospitals. METHODS This was a nonrandomized feasibility study performed at 2 institutions. After institutional review board approval, the patients underwent the TRIM endoluminal gastric plication procedure with the Restore Suturing System (Restore device). Gastric plications were completed to approximate the anterior and posterior gastric walls to achieve restriction of the upper stomach. The number and location of successful plications were recorded, and patients were monitored for complications. The present report described the short-term procedural results (≤ 24 hours after the procedure) of the studied cohort. RESULTS A total of 18 patients were enrolled in the present study. The TRIM procedure was successfully completed in all patients, with placement of 4-8 plications (average 6 per patient). The average procedure time was 125 ± 23 minutes, and no serious or significant procedure-related complications occurred. After the procedure, common patient complaints were nausea, vomiting, and abdominal discomfort. The first 10 patients enrolled were kept overnight according to the study protocol, and the remaining 8 patients were discharged on the day of the procedure. CONCLUSION Endoluminal suturing using the TRIM procedure and the Restore device was technically feasible, and no serious or significant procedure-related complications were reported. Weight loss, co-morbidity improvement, and durability are under assessment.

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Tomasz Rogula

Case Western Reserve University

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