PCORnet Bariatric Study

2016-04-18 17:38:22 | BioPortfolio


The main goal of this research project is to conduct a comparative effectiveness research study involving existing data in the PCORnet Common Data Model to provide accurate estimates of the 1-, 3-, and 5-year benefits and risks of the three most common bariatric procedures - Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy - with a focus on outcomes that are important to adults and adolescents with severe obesity: 1) changes in weight, 2) rates of remission and relapse of diabetes, and 3) major adverse events.


The main aims of this study will compare the effectiveness and safety of the three most common bariatric surgical procedures: Roux-en-y gastric bypass (RYGB), adjustable gastric banding (AGB), and sleeve gastrectomy (SG).

Question (Aim) 1: To what extent does weight loss and weight regain differ across the three bariatric surgical procedures at 1, 3, and 5 years? This aim addresses the primary outcome of interest among most patients seeking bariatric surgery - the differential impact of these procedures on maximum weight loss as well as the extent of longer-term weight regain. We will also explore the heterogeneity in weight loss and regain across several key subgroups that may have differential response to surgical treatment, specifically groups defined by age, race/ethnicity, baseline BMI, smoking status, and pre-operative comorbidities.

Question (Aim) 2: To what extent do these bariatric procedures differ on improvements in diabetes risk at 1, 3, and 5 years? Among patients with diabetes, remission or "cure" of their disease (defined as HbA1c <6.5% off diabetes medications) has been cited as the most important outcome of bariatric surgery. Thus, we will examine the comparative effect of these procedures on rates of diabetes remission as well as relapse (recurrence). Secondary analyses will examine the comparative impact of the procedures on glycemic control independent of diabetes remission.

Question (Aim) 3: What is the frequency of major adverse events following these three different bariatric surgical procedures at 1, 3, and 5 years? We will examine four important adverse event outcome categories across the three procedures: 1) short- and long-term (1, 3, and 5 year) mortality rates, 2) a composite end point of 30-day major adverse outcomes: based on the definition used in the Longitudinal Assessment of Bariatric Surgery (LABS) study that included death; venous thromboembolism; percutaneous, endoscopic, or operative subsequent intervention; and failure to be discharged from the hospital; 3) subsequent hospitalization (any hospitalization following initial surgery); and 4) subsequent reoperation/reintervention: defined as any additional bariatric procedure and other procedures related to device removals, gastric revisions, abdominal or incisional hernia repair, laparoscopy or laparotomy, and percutaneous endoscopic gastrostomy tube placements.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective




Roux-en-y gastric bypass (RYGB) - historical, Adjustable gastric banding (AGB) - historical, Sleeve gastrectomy (SG) - historical


Enrolling by invitation


Group Health Cooperative

Results (where available)

View Results


Published on BioPortfolio: 2016-04-18T17:38:22-0400

Clinical Trials [2327 Associated Clinical Trials listed on BioPortfolio]

One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass

The aim of this prospective randomized controlled trial is to compare the two procedures One-anastomosis gastric Bypass/Mini-gastric Bypass (OAGB/MGB) and Roux-en Y gastric bypass (RYGB) i...

The Effect of Roux-en-Y Gastric Bypass on Bone Turnover

Bone mineral density (BMD) is decreased after Roux-en-Y gastric bypass (RYGB) but whether RYGB induces changes in BMD beyond adaptation to major weight loss is not known. We aim to investi...

Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID)

This research study will investigate the safety and effectiveness of weight loss surgery for overweight persons with type 2 diabetes. Eligible patients will be randomly assigned to one of...

Reversibility of Dysmotility After Gastric Banding

In the current study we plan to evaluate the effects of the conversion from gastric banding to gastric bypass on esophageal function using combined monitoring. The primary aim of the curre...

Banded Versus Non-banded Roux-en-y Gastric Bypass

A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to p...

PubMed Articles [2661 Associated PubMed Articles listed on BioPortfolio]

Fracture Risk After Roux-en-Y Gastric Bypass vs Adjustable Gastric Banding Among Medicare Beneficiaries.

Roux-en-Y gastric bypass (RYGB) is associated with significant bone loss and may increase fracture risk, whereas substantial bone loss and increased fracture risk have not been reported after adjustab...

One Anastomosis Gastric Bypass Versus Roux-en-Y Gastric Bypass for Morbid Obesity: an Updated Meta-Analysis.

We aim to review the available literature on morbidly obese patients treated with one anastomosis gastric bypass (OAGB) or Roux-en-Y gastric bypass (RYGB) in order to compare the clinical outcomes of ...

Conversion of Adjustable Gastric Banding to Stapling Bariatric Procedures: Single- or Two-stage Approach.

The aim of this study was to compare the safety of single- versus two-stage conversion of adjustable gastric band (AGB) to gastric bypass (RYGB) or sleeve gastrectomy (SG).

Short-Term Outcomes of Inflammatory Bowel Disease after Roux-En-Y Gastric Bypass vs Sleeve Gastrectomy.

Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) are the most effective therapies for obesity and may have beneficial effects on the immune system. Therefore, we compared RYGB versus SG out...

Contribution of endogenous glucagon-like Peptide-1 to changes in glucose metabolism and islet function in people with type 2 diabetes four weeks after roux-en-Y gastric bypass (RYGB).

Glucagon-Like Peptide-1 (GLP-1) is an insulin secretagogue which is elevated after Roux-en-Y Gastric Bypass (RYGB). However, its contribution to glucose metabolism after RYGB remains uncertain.

Medical and Biotech [MESH] Definitions

Abnormal distention of the STOMACH due to accumulation of gastric contents that may reach 10 to 15 liters. Gastric dilatation may be the result of GASTRIC OUTLET OBSTRUCTION; ILEUS; GASTROPARESIS; or denervation.

Vagal denervation of that part of the STOMACH lined with acid-secreting mucosa (GASTRIC MUCOSA) containing the GASTRIC PARIETAL CELLS. Since the procedure leaves the vagal branches to the antrum and PYLORUS intact, it circumvents gastric drainage required with truncal vagotomy techniques.

Rounded or pyramidal cells of the GASTRIC GLANDS. They secrete HYDROCHLORIC ACID and produce gastric intrinsic factor, a glycoprotein that binds VITAMIN B12.

A synthetic methylprostaglandin E1 analog that reduces gastric acid secretion and enhances the gastric mucus-bicarbonate barrier. It is effective in the therapy of gastric ulcers and gives significant protection against NSAID-induced gastric mucosal damage. The drug also prevents cyclosporin A-induced damage to endocrine and exocrine pancreatic secretions. It shows a low order of acute toxicity and there is no evidence of embryotoxicity, fetotoxicity, teratogenicity, or mutagenicity in animal studies.

A subtype of cholecystokinin receptor found primarily in the CENTRAL NERVOUS SYSTEM and the GASTRIC MUCOSA. It may play a role as a neuromodulator of dopaminergic neurotransmission the regulation of GASTRIC ACID secretion from GASTRIC PARIETAL CELLS.

More From BioPortfolio on "PCORnet Bariatric Study"

Quick Search

Relevant Topics

Obesity is the condition in which excess fat has accumulated in the body (mostly in subcutaneous tissues). clinical obesity is considered to be present when a person has a BMI of over 30 (Oxford Dictionary of Medicine). It is becoming increasing common i...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Searches Linking to this Trial