Implantable gastric stimulation for the treatment of clinically severe obesity: results of the SHAPE trial
ABSTRACT BackgroundTo compare implantable gastric stimulation therapy with a standard diet and behavioral therapy regimen in a group of carefully selected class 2 and 3 obese subjects by evaluating the difference in the percentage of excess weight loss (EWL) between the control and treatment groups. The primary endpoint was the percentage of EWL from baseline to 12 months after randomization. Implantable gastric stimulation has been proposed as a first-line treatment for severely obese patients; however, previous investigations have reported inconclusive results.MethodsA total of 190 subjects were enrolled in this prospective, randomized, placebo-controlled, double-blind, multicenter study. All patients underwent implantation with the implantable gastric stimulator and were randomized to 1 of 2 treatment groups: the control group (stimulation off) or treatment group (stimulation on). The patients were evaluated on a monthly basis. All individuals who enrolled in this study agreed to consume a diet with a 500-kcal/d deficit and to participate in monthly support group meetings.ResultsThe procedure resulted in no deaths and a low complication rate. The primary endpoint of a difference in weight loss between the treatment and control groups was not met. The control group lost 11.7% ± 16.9% of excess weight and the treatment group lost 11.8% ± 17.6% (P = .717) according to an intent-to-treat analysis.ConclusionImplantable gastric stimulation as a surgical option for the treatment of morbid obesity is a less complex procedure than current bariatric operations. However, the results of the present study do not support its application. Additional research is indicated to understand the physiology and potential benefits of this therapy.
- SourceAvailable from: Abraham J Botha[Show abstract] [Hide abstract]
ABSTRACT: Not too long ago surgeons routinely treated metabolic problems including hypertension, hyperlipidaemia and obesity. However, these areas declined as drug therapies became available and surgical approaches lost favour due to high rates of perceived complications. Surgery survived in specialist metabolic oncological applications for treatment of endocrine adenomas or carcinomas. Metabolic endocrine surgery has grown ever more sophisticated with better imaging, more sensitive sampling techniques, intra-operative endocrine monitoring using point-of-care assay technologies and the increasing use of minimal access and eventually robotic surgery techniques (1-3). The diagnosis of primary hyperparathyroidism (PHPT) is more frequently made at a significantly earlier stage than in the past. Surgery is performed for both prognostic benefit and symptom relief. Surgical approaches have evolved rapidly in recent years with an evolution in minimally invasive procedures aided by improvements in pre-operative localisation (4). Day surgery procedures are common and intra-operative assays of parathyroid hormone can be used to confirm surgical success in minutes. Type II calcimimetic drugs that enhance the sensitivity of the calcium-sensing receptor to calcium resulting in a decrease in PTH secretion are used in secondary hyperparathyroidism reducing the need for surgery in some patients (5), and may also have a selective role in complicated patients with PHPT and malignancy. In other areas surgery disappeared such as when initially H2 antagonists and later proton pump inhibitors (PPIs) replaced the need for gastric acid reduction by vagotomy.International Journal of Clinical Practice 07/2011; 65(7):728-32. DOI:10.1111/j.1742-1241.2011.02696.x · 2.54 Impact Factor
Conference Paper: Single photon emission local tomography (SPELT)[Show abstract] [Hide abstract]
ABSTRACT: Local tomography uses truncated projection data to reconstruct a region of interest, and is important in medical imaging and industrial non-destructive evaluation using micro X-ray CT. The popular filtered backprojection (FBP) algorithm does not reconstruct a reliable image, which varies with the degree and location of truncation due to its global convolution kernel. A typical local tomography method uses a second derivative local operator to replace the global convolution kernel in the filtered backprojection algorithm (LFBP). By using a local filter, the reconstructed region depends only on the local projections. The singularities (edges) are preserved, but the exact image value cannot be recovered. This paper, using the data consistency conditions, developed a pre-processing technique that uses the FBP algorithm, which outperforms direct FBP and LFBPNuclear Science Symposium, 1996. Conference Record., 1996 IEEE; 12/1996
Conference Paper: Simulation of phased array techniques for realistic NDE configurations[Show abstract] [Hide abstract]
ABSTRACT: In this communication we briefly present the phased array simulation tools developed at the CEA in the aim of driving delays laws, predicting ultrasonic beams, simulating and processing acquired data. These tools allow to manage NDT inspections in complex configurations. We present some examples on such configurations illustrating the interest and reliability of simulation.Ultrasonics Symposium, 2002. Proceedings. 2002 IEEE; 11/2002