Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial.

Background: We compared the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) to best medical treatment in patients with diabetic kidney disease and obesity to determine which treatment is better. Methods: A 5 year, open-label, single-centre, randomised trial studied patients with diabetic kidney disease and class I obesity after 1:1 randomization to best medical treatment (n = 49) or RYGB (n = 51). The primary outcome was the proportion of patients achieving remission of microalbuminuria after 5 years. Secondary outcomes included improvements in diabetic kidney disease, glycemic control, quality of life, and safety. For efficacy outcomes, we performed an intention-to-treat (ITT) analysis. This study was registered with ClinicalTrials.gov, NCT01821508. Findings: 88% of patients (44 per arm) completed 5-year follow-up. Remission of albuminuria occurred in 59.6% (95% CI = 45.5-73.8) after best medical treatment and 69.7% (95% CI = 59.6-79.8) after RYGB (risk difference: 10%, 95% CI, -7 to 27, P = 0.25). Patients after RYGB were twice as likely to achieve an HbA1c ≤ 6.5% (60.2% versus 25.4%, risk difference, 34.9%; 95% CI = 15.8-53.9, P < 0.001). Quality of life after five years measured by the 36-Item Short Form Survey questionnaire (standardized to a 0-to-100 scale) was higher in the RYGB group than in the best medical treatment group for several domains. The mean differences were 13.5 (95% CI, 5.5-21.6, P = 0.001) for general health, 19.7 (95% CI, 9.1-30.3, P < 0.001) for pain, 6.1 (95% CI, -4.8 to 17.0, P = 0.27) for social functioning, 8.3 (95% CI, 0.23 to 16.3, P = 0.04) for emotional well-being, 12.2 (95% CI, 3.9-20.4, P = 0.004) for vitality, 16.8 (95% CI, -0.75 to 34.4, P = 0.06) for mental health, 21.8 (95% CI, 4.8-38.7, P = 0.01) for physical health and 11.1 (95% CI, 2.24-19.9, P = 0.01) for physical functioning. Serious adverse events were experienced in 7/46 (15.2%) after best medical treatment and 11/46 patients (24%) after RYGB (P = 0.80). Interpretation: Albuminuria remission was not statistically different between best medical treatment and RYGB after 5 years in participants with diabetic kidney disease and class 1 obesity, with 6-7 in ten patients achieving remission of microalbuminuria (uACR <30 mg/g) in both groups. RYGB was superior in improving glycemia, diastolic blood pressure, lipids, body weight, and quality of life. Funding: The study was supported by research grants from Johnson & Johnson Brasil, Oswaldo Cruz German Hospital, and by grant 12/YI/B2480 from Science Foundation Ireland (Dr le Roux) and grant 2015-02733 from the Swedish Medical Research Council (Dr le Roux). Dr Pereira was funded by the Chevening Scholarship Programme (Foreign and Commonwealth Office, UK).

Effect of Gastric Bypass vs Best Medical Treatment on Early-Stage Chronic Kidney Disease in Patients With Type 2 Diabetes and Obesity: A Randomized Clinical Trial.

Importance: Early-stage chronic kidney disease (CKD) characterized by microalbuminuria is associated with future cardiovascular events, progression toward end-stage renal disease, and early mortality in patients with type 2 diabetes. Objective: To compare the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) surgery vs best medical treatment in patients with early-stage CKD, type 2 diabetes, and obesity. Design, Setting, and Participants: For this randomized clinical trial, patients with established type 2 diabetes and microalbuminuria were recruited from a single center from April 1, 2013, through March 31, 2016, with a 5-year follow-up, including prespecified intermediate analysis at 24-month follow-up. Intervention: A total of 100 patients with type 2 diabetes, obesity (body mass indexes of 30 to 35 [calculated as weight in kilograms divided by height in meters squared]), and stage G1 to G3 and A2 to A3 CKD (urinary albumin-creatinine ratio [uACR] >30 mg/g and estimated glomerular filtration rate >30 mL/min) were randomized 1:1 to receive best medical treatment (n = 49) or RYGB (n = 51). Main Outcomes and Measures: The primary outcome was remission of albuminuria (uACR <30 mg/g). Secondary outcomes were CKD remission rate, absolute change in uACR, metabolic control, other microvascular complications, quality of life, and safety. Results: A total of 100 patients (mean [SD] age, 51.4 [7.6] years; 55 [55%] male) were randomized: 51 to RYGB and 49 to best medical care. Remission of albuminuria occurred in 55% of patients (95% CI, 39%-70%) after best medical treatment and 82% of patients (95% CI, 72%-93%) after RYGB (P = .006), resulting in CKD remission rates of 48% (95% CI, 32%-64%) after best medical treatment and 82% (95% CI, 72%-92%) after RYGB (P = .002). The geometric mean uACRs were 55% lower after RYGB (10.7 mg/g of creatinine) than after best medical treatment (23.6 mg/g of creatinine) (P < .001). No difference in the rate of serious adverse events was observed. Conclusions and Relevance: After 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity. Trial Registration: ClinicalTrials.gov Identifier: NCT01821508.

Shifts in intestinal microbiota after duodenal exclusion favor glycemic control and weight loss: a randomized controlled trial.

BACKGROUND: In recent years, studies indicate gut microbiota as an important modulator in the pathophysiology of type 2 diabetes. Environmental and genetic factors interact to control the host's intestinal microbiota, triggering metabolic disorders such as obesity and insulin resistance. OBJECTIVES: The objective of this study was to identify the fecal microbiota in adult type 2 diabetes patients and to assess changes in composition after metabolic surgery. SETTING: University Hospital of the University of São Paulo. METHODS: Twenty-one patients were enrolled in a randomized controlled study divided into 2 arms. One group underwent duodenal-jejunal bypass surgery with minimal gastric resection, and fecal samples were collected before the operation and after 6 and 12 months. The other group received medical care (standard care group) and was followed for 12 months. Fecal samples were collected at baseline and after 6 and 12 months. Fecal microbiota was analyzed using high-throughput sequencing with V4 16 S rRNA primers. RESULTS: The fecal microbiota in duodenal-jejunal bypass surgery with minimal gastric resection group (Bacteroides, Akkermansia, and Dialister) exhibited increased abundance and diversity compared with that in the standard care group; however, the increase in A. muciniphila was only statistically significant in the surgical group, probably due to the study's small sample size. CONCLUSIONS: The data presented suggest that duodenal-jejunal bypass surgery with minimal gastric resection increases microbial richness and abundancy, mainly for those bacteria related to weight loss and metabolic control (Akkermansia), providing a better understanding of the role of microbiota in type 2 diabetes regulation and its changes after metabolic surgery.

The Role of Metabolic Surgery in Non-alcoholic Steatohepatitis Improvement.

PURPOSE OF REVIEW: Non-alcoholic fatty liver disease (NAFLD) is frequently associated with obesity and overweight. It has a broad spectrum of clinical and histological presentations, such as steatosis, inflammation (known as non-alcoholic steatohepatitis or NASH), fibrosis, and cirrhosis. There is increasing evidence that marked weight loss following bariatric surgery is associated with NASH resolution; however, little is known about the mechanisms that may lead to this beneficial condition and if it is due to weight loss alone. In this review, the authors present the latest data regarding NASH resolution following metabolic surgery and try to answer the following questions: is NASH resolution due to weight loss alone or is it related to weight-independent effects similarly to T2D? In such case, can NASH be considered as a sole criterion for metabolic surgery? RECENT FINDINGS: Most data evaluating NAFLD and bariatric and metabolic surgery are derived from cohort studies. Available data are extremely variable, but in general show a dramatic regression of steatosis, inflammatory changes, and in some cases even fibrosis that is probably linked to major weight loss following surgery. There are no randomized controlled trials evaluating the effects of metabolic surgery over NASH vs. lifestyle modifications. To consider NASH a sole indication for metabolic surgery regardless of BMI, such studies are desperately needed and should be the primary focus of future research in metabolic surgery.

Microvascular Outcomes after Metabolic Surgery (MOMS) in patients with type 2 diabetes mellitus and class I obesity: rationale and design for a randomised controlled trial.

INTRODUCTION: There are several randomised controlled trials (RCTs) that have already shown that metabolic/bariatric surgery achieves short-term and long-term glycaemic control while there are no level 1A of evidence data regarding the effects of surgery on the microvascular complications of type 2 diabetes mellitus (T2DM). PURPOSE: The aim of this trial is to investigate the long-term efficacy and safety of the Roux-en-Y gastric bypass (RYGB) plus the best medical treatment (BMT) versus the BMT alone to improve microvascular outcomes in patients with T2DM with a body mass index (BMI) of 30-34.9 kg/m2. METHODS AND ANALYSIS: This study design includes a unicentric randomised unblinded controlled trial. 100 patients (BMI from 30 to 34.9 kg/m2) will be randomly allocated to receive either RYGB plus BMT or BMT alone. The primary outcome is the change in the urine albumin-to-creatinine ratio (uACR) captured as the proportion of patients who achieved nephropathy remission (uACR<30 mg/g of albumin/mg of creatinine) in an isolated urine sample over 12, 24 and 60 months. ETHICS AND DISSEMINATION: The study was approved by the local Institutional Review Board. This study represents the first RCT comparing RYGB plus BMT versus BMT alone for patients with T2DM with a BMI below 35 kg/m2. TRIAL REGISTRATION NUMBER: NCT01821508; Pre-results.

Mechanisms of Action of Surgical Interventions on Weight-Related Diseases: the Potential Role of Bile Acids.

Surgical interventions for weight-related diseases (SWRD) may have substantial and sustainable effect on weight reduction, also leading to a higher remission rate of type 2 diabetes (T2D) mellitus than any other medical treatment or lifestyle intervention. The resolution of T2D after Roux-en-Y gastric bypass (RYGB) typically occurs too quickly to be accounted for by weight loss alone, suggesting that these operations have a direct impact on glucose homeostasis. The mechanisms underlying these beneficial effects however remain unclear. Recent research suggests that changes in the concentrations of plasma bile acids might contribute to these metabolic changes after surgery. In this review, we aimed to outline the potential role of bile acids in SWRD. We systematically reviewed MEDLINE, SCOPUS, and Web of Science for articles reporting the effect of SWRD on outcomes published between 1969 and 2016. We found that changes in circulating bile acids after surgery may play a major role through activation of the farnesoid X receptor A (FXRA), the fibroblast growth factor 19 (FGF19), and the G protein-coupled bile acid receptor (TGR5). Bile acid concentration increased significantly after RYGB. Some studies suggest that a transitory decrease occurs at 1 week post-surgery, followed by a gradual increase. Most studies have shown the increase to be proportionate by all bile acid subtypes. Bile acids can regulate glucose metabolism through the expression of TGR5 receptor in L cells, resulting in a release of glucagon-like peptide 1 (GLP-1). It may also induce the synthesis and secretion of FGF19 in ileal cells, thereby improving insulin sensitivity and regulating glucose metabolism. All the present SWRD are involved with changes in food stimulation to the stomach. This implies that discovering and developing the antagonists to TGR5 and FXRA may effectively control metabolic syndrome and the elucidation of the mechanisms underlying the physiological effects related to weight loss and T2D remission after surgery may help to identify new drug targets.

Changing Guidelines for Metabolic Surgery: Now It's the Time!

The governing criteria for bariatric surgery dates back from 1991 and is based solely on body mass index (BMI) as the primary operative criterion, restricting surgery to severely obese patients. Although this was a tremendous step forward in standardizing practice, these guidelines now have important limitations. During the two decades since they were crafted, bariatric surgery has evolved. Also, new procedures are now being performed, as demonstrated by level-1 evidence from randomized controlled trials comparing surgical versus clinical approaches to obesity and related diseases. Although simple and inexpensive, BMI is not a good tool to choose the best treatment option. There is little doubt that BMI alone is not an appropriate indication for surgery and could exclude many patients who could benefit from this life-saving treatment, especially patients with T2DM and lower BMIs. In this matter, new guidelines are urgently needed in order to guarantee, regulate, and reimburse metabolic surgery.

Innovative metabolic operations.

Bariatric surgery was developed with the aim of weight reduction. Success was defined only by excess weight loss. Other indices of resolution of metabolic co-morbidities were reported but were mostly secondary. Several communications have reported that regardless of body mass index (BMI), complete or partial remission of type 2 diabetes (T2D) is possible with such traditional gastrointestinal operations as the Roux-en-Y gastric bypass, bileopancreatic diversion, and sleeve gastrectomy. These results mostly occur before weight loss, positioning metabolic surgery as a good tool for controlling the current T2D epidemic. Surgery aimed mainly at the diseases, such as diabetes, and not weight loss are referred to as metabolic surgery. Metabolic surgery can effectively treat T2D in individuals with any BMI, including that below 35 kg/m(2). Concurrently, some new procedures were developed to treat patients that in theory do not need massive weight loss, focusing on a pathophysiological approach to T2D. Those new techniques, mainly duodenal jejunal bypass, ileal transposition, single-anastomosis duodenal ileal or jejunal bypass with sleeve gastrectomy, and the endoscopic duodenal liner, are experimental procedures, most reporting good metabolic control initially without relation to weight variation.

The Diabetes Surgery Summit II Guidelines: a Disease-Based Clinical Recommendation.

There is mounting evidence, derived from mechanistic studies, RCTs, and other high-quality studies that there are weight loss independent antidiabetic effects of gastrointestinal surgery. Additionally, there appears to be no relation between the positive metabolic outcomes to baseline BMI. The outdated US National Health Institutes guidelines from 1991 were centered on BMI only criterion and often misleading. The Second Diabetes Surgery Summit held in collaboration with leading diabetes organizations and endorsed by a large group of international Professional Societies developed guidelines that defined eligibility based on the severity and degree of T2D medical control while referring to obesity as a qualifier and not the sole criterion. That is the first time that guidelines are provided to put metabolic surgery into the T2D treatment algorithms.

Bariatric and metabolic surgery and microvascular complications of type 2 diabetes mellitus.

INTRODUCTION: Metabolic dysregulation is the defining characteristic of type 2 diabetes mellitus (T2DM) and may lead to microvascular complications, specifically retinopathy, nephropathy and neuropathy. Medical treatment and lifestyle interventions targeting risk factors for microvascular complications can yield therapeutic gains, particularly retinopathy and nephropathy. Bariatric/metabolic surgery is superior to the best medical treatment in several randomized controlled trials. Consequently, evidence of the effect of bariatric/metabolic surgery on microvascular complications is now emerging in the literature. METHODS: A search of the recent published evidence base on the effects of bariatric/metabolic surgery on microvascular complications reveals further evidence that supports the efficacy of surgery in preventing the incidence and progression of albuminuria and preserving renal functional decline. DISCUSSION: Data on retinopathy are ambivalent representing the potential in some cases for an influence of reactive hypoglycaemia over the retina but the majority of data emphasize that the metabolic control can halt the progression of the eye disease. A significant gap in the literature remains in relation to the effects of surgery on diabetic neuropathy, although some information sheds a light on the benefits secondary to the surgical metabolic control. CONCLUSION: Overall, although data so far is exciting, there is a pressing need for prospective randomized controlled trials examining long-term microvascular outcomes following bariatric/metabolic surgery in patients with T2DM.

Effect of Duodenal-Jejunal Bypass Surgery on Glycemic Control in Type 2 Diabetes: A Randomized Controlled Trial.

OBJECTIVE: To determine whether upper gastrointestinal tract (UGI) bypass itself has beneficial effects on the factors involved in regulating glucose homeostasis in patients with type 2 diabetes (T2D). METHODS: A 12-month randomized controlled trial was conducted in 17 overweight/obese subjects with T2D, who received standard medical care (SC, n = 7, BMI = 31.7 ± 3.5 kg/m(2) ) or duodenal-jejunal bypass surgery with minimal gastric resection (DJBm) (n = 10; BMI = 29.7 ± 1.9 kg/m(2)). A 5-h modified oral glucose tolerance test was performed at baseline and at 1, 6, and 12 months after surgery or starting SC. RESULTS: Body weight decreased progressively after DJBm (7.9 ± 4.1%, 9.6 ± 4.2%, and 10.2 ± 4.3% at 1, 6, and 12 months, respectively) but remained stable in the SC group (P < 0.001). DJBm, but not SC, improved: (1) oral glucose tolerance (decreased 2-h glucose concentration, P = 0.039), (2) insulin sensitivity (decreased homeostasis model assessment of insulin resistance, P = 0.013), (3) early insulin response to a glucose load (increased insulinogenic index, P = 0.022), and (4) overall glycemic control (reduction in HbA1c with fewer diabetes medications). CONCLUSIONS: DJBm causes moderate weight loss and improves metabolic function in T2D. However, our study cannot separate the benefits of moderate weight loss from the potential therapeutic effect of UGI tract bypass itself on the observed metabolic improvements.

Cirurgia bariátrica e metabólica e complicações microvasculares do diabetes mellitus tipo 2 (DM2) / Bariatric and metabolic surgery and microvascular complications of type 2 diabetes mellitus

ResumoIntrodução:O diabetes mellitus tipo 2 (DM2) é caracterizado por uma desregulação metabólica, originando complicações microvasculares, mais especificamente a retinopatia, nefropatia e a neuropatia. A prevenção e tratamento das complicações são alvo da farmacoterapia, porém, evidências demonstram que a cirurgia bariátrica/metabólica é superior ao melhor tratamento farmacológico, pois apresenta melhor controle da glicemia, hipertensão e dislipidemias.Métodos:Por meio de pesquisa no PubMed, são discutidas as recentes publicações que evidenciam o efeito positivo das intervenções cirúrgicas sobre as complicações microvasculares, como melhora da microalbuminúria e mesmo preservação de função renal.Discussão:Existem evidências de benefício das operações bariátricas/metabólicas sobre a nefropatia diabética. Os dados sobre retinopatia são ainda ambivalentes. Na literatura, há uma diferença significativa no benefício da cirurgia em neuropatia.Conclusão:Apesar de resultados surpreendentes e positivos, para que se estabeleça definitivamente o papel da cirurgia bariátrica/metabólica nas complicações micovasculares do DM2, há a necessidade de novos estudos randomizados controlados e prospectivos.

AbstractIntroduction:Metabolic dysregulation is the defining characteristic of type 2 diabetes mellitus (T2DM) and may lead to microvascular complications, specifically retinopathy, nephropathy and neuropathy. Medical treatment and lifestyle interventions targeting risk factors for microvascular complications can yield therapeutic gains, particularly retinopathy and nephropathy. Bariatric/metabolic surgery is superior to the best medical treatment in several randomized controlled trials. Consequently, evidence of the effect of bariatric/metabolic surgery on microvascular complications is now emerging in the literature.Methods:A search of the recent published evidence base on the effects of bariatric/metabolic surgery on microvascular complications reveals further evidence that supports the efficacy of surgery in preventing the incidence and progression of albuminuria and preserving renal functional decline.Discussion:Data on retinopathy are ambivalent representing the potential in some cases for an influence of reactive hypoglycaemia over the retina but the majority of data emphasize that the metabolic control can halt the progression of the eye disease. A significant gap in the literature remains in relation to the effects of surgery on diabetic neuropathy, although some information sheds a light on the benefits secondary to the surgical metabolic control.Conclusion:Overall, although data so far is exciting, there is a pressing need for prospective randomized controlled trials examining long-term microvascular outcomes following bariatric/metabolic surgery in patients with T2DM.

How Durable Are the Effects After Metabolic Surgery?

Bariatric surgery was initially developed as a tool for weight reduction only, but it is gaining popularity because of its remarkable effect on glucose metabolism in morbidly obese and less obese patients. Recent publications have shown the superiority of metabolic surgery over medical treatment for diabetes, creating a new field of clinical research that is currently overflowing in the medical community with outstanding high-quality data. Metabolic surgery is effective in treating diabetes, even in non-morbidly obese patients.

Role of metabolic surgery in less obese or non-obese subjects with type 2 diabetes: influence over cardiovascular events.

Bariatric surgery was initially developed as a tool for weight reduction only, but it is gaining increasing popularity because of its remarkable effect on glucose metabolism in morbidly obese and less obese patients. Recent publications have shown the good results of metabolic surgery, creating a new field of clinical research that is currently overflowing in the medical community with outstanding high-quality data. In morbidly obese population, there is compelling data on long term cardiovascular risk reduction and mortality, coming from longitudinal prospective studies and systematic reviews. Numbers range from 33 to 92% of decrease in fatal and nonfatal cardiovascular events . In low body mass index (BMI) diabetics, there is an increasing number of reported good outcomes after metabolic surgery with the aim to treat type 2 diabetes (T2DM). There is scarce information on cardiovascular outcomes in non-morbidly obese subjects, but the extraordinary glucose, lipid and blood pressure control in the published series are suggesting good long-term effects on cardiovascular risk profile and mortality. The papers review was comprehensive, including the available randomized controlled trials, long-term prospective series and systematic reviews.

Metabolic Surgery for Type 2 Diabetes in Patients with a BMI of <35 kg/m(2): A Surgeon's Perspective.

Bariatric surgery was developed with the aim of weight reduction. Success was defined only by excess weight loss. Other indices of resolution of metabolic comorbidities were reported, but were mostly secondary. Several communications have reported that regardless of body mass index (BMI), complete or partial remission of type 2 diabetes mellitus (T2DM) is possible. These results mostly occur before weight loss, positioning metabolic surgery as a good tool for controlling the current T2DM epidemic. Medical treatment is evolving, but is expensive and not risk-free. Surgery aimed mainly at diseases such as diabetes and not weight loss are referred to as "metabolic surgery." Metabolic surgery has been proven to be safe and effective, and although more data are needed, it is unquestionable that a new discipline has been founded. Metabolic surgery can effectively treat T2DM in individuals with any BMI, including that below 35 kg/m(2).

Glycemic control after stomach-sparing duodenal-jejunal bypass surgery in diabetic patients with low body mass index.

BACKGROUND: Bariatric surgery frequently results in the resolution of type 2 diabetes mellitus (T2DM). One of the many factors that could explain such findings is the duodenal exclusion of the alimentary tract. To test this hypothesis, a surgical model that induces glycemic control without significant weight loss would be ideal. In the present study, we evaluated the early metabolic changes that occur in overweight diabetic patients after laparoscopic duodenal-jejunal bypass (DJB) and determined the factors associated with success in T2DM resolution. The setting was a private practice. METHODS: A total of 35 patients (20 men and 15 women) were included in the present study. The mean preoperative body mass index was 28.4 ± 2.9 kg/m(2). DJB was performed in all patients, and the anthropometric data and blood samples were collected at baseline (preoperatively) and 3, 6, 9, and 12 months after surgery. Success was defined when patients reached a glycated hemoglobin level of <7% without diabetic medication. RESULTS: T2DM remission was observed in 14 (40%) of 35 patients. No differences in the homeostasis model assessment insulin resistance index levels and patient weight were observed before and 12 months after DJB surgery. Gender, duration of T2DM, previous use of insulin, preoperative homeostasis model assessment insulin resistance index, and C-peptide levels were not significant predictive factors of success or nonsuccess. The only factor that significantly predicted postoperative positive outcomes was a waist circumference reduction of ≥ 7% compared with baseline within the first 6 months after surgery. CONCLUSION: DJB improves glycemic control; however, it does not increase insulin sensitivity in overweight diabetic patients. These changes were observed without significant weight loss.

Early and late results of topical diltiazem and bethanechol for chronic anal fissure: a comparative study.

BACKGROUND/AIMS: Late efficacy of medical treatment of chronic anal fissure remains controversial due to high recurrence. This study aimed at analyzing safety and efficacy of topical diltiazem and bethanechol regarding healing and symptoms relief, safety, recurrence, and need for surgery. METHODOLOGY: This was a single-center nonrandomized trial. Outcomes of 30 patients with chronic anal fissure treated with 2% diltiazem were compared to 30 patients treated with 0.1% bethanechol, both for eight weeks. Patients were assessed after seven days and eight weeks. RESULTS: In diltiazem group, after seven days, 31% were symptomatic; after bethanechol, 71% (p = 0.06). After seven days, fissure healing occurred in 19% after diltiazem and in 11% after bethanechol. After eight weeks, in both groups, 64% were asymptomatic; after diltiazem, 53% healed; after bethanechol, 50% (p = 0.80). Success was the same for both groups: 63.3%. Groups were similar regarding complications. After diltiazem, 9 (30%) patients were operated on; and 11 (36.7%) after bethanechol (p = 0.60). Recurrence occurred in 4 (13.3%) patients in both groups. Median time to recurrence after diltiazem was 15 (10-24) months and 7.5 (2-15) after bethanechol - p = 0.15. CONCLUSIONS: Both treatments are safe and effective. Diltiazem may be associated to earlier relief and more sustained response.

Incidence and management of colonoscopic colon perforations: 10 years' experience.

BACKGROUND/AIMS: This paper aimed to review experience with diagnostic and therapeutic colonoscopies performed by a colorectal surgeon with special interest in colonoscopy over a 10-yr period and to assess incidence and management of colonic perforations. METHODOLOGY: All colonoscopies performed between 1997 and 2007 were studied. Data on patients, colonoscopic reports and procedure-related complications were collected from computerized database. Medical records of patients with colonic perforation were reviewed. RESULTS: 7,804 colonoscopies were performed. Five colonoscopic perforations were identified (0.06%). Three occurred during diagnostic and two during therapeutic colonoscopy. All were suspected during or immediately after colonoscopy except for one therapeutic perforation diagnosed two days after the procedure. All perforations were surgically managed by the author. Surgery included conventional and laparoscopic repair, colectomy and proctocolectomy. There was need for stoma in one patient with pancolonic Crohn's disease with sigmoid colon stenosis. This patient underwent total proctocolectomy. There were no deaths. CONCLUSIONS: The rate of perforation during colonoscopy is low and can be managed with no mortality. Early diagnosis and treatment are essential. Early operative intervention through primary repair represents is safe and effective. Managing colonic pathology demanding resection in the urgent setting may benefit selected patients with colonoscopy perforation.

Colorectal cancer among patients aged 75 years or over.

BACKGROUND/AIMS: The aim of this study is to evaluate the risk factors for mortality, morbidity, and long-term survival in elderly patients with colorectal cancer when compared to younger patients. METHODOLOGY: Patients operated on with colorectal cancer were divided into 2 groups according to age: Group 1 (75 years old or older, n=90) and group 2 (<75 years, n=430). RESULTS: Preoperative hemoglobin levels were lower in group 1 (p = 0.008). Poorer clinical status defined by ASA score (p = 0.008) results and blood transfusions (p = 0.003) were more frequent in group 1 when compared to group 2. Group 1 had a significantly higher operative mortality rate than group 2 (p = 0.01). Regarding cancer-related survival after 1, 2, and 4 years, there was no significant difference between the 2 groups. CONCLUSIONS: Poorer clinical conditions with special regard to anemia are more frequent among patients of 75 years and older and this finding may lead to an increase in operative mortality when compared to younger patients. Even though, senior patients with colorectal cancer should not be denied surgical and adjuvant therapy on account of age alone since cancer-related survival remains comparable to younger patients' results.