Trial reportObesity surgery2004
"What are the yanks doing?" the U.S. experience with implantable gastric stimulation (IGS) for the treatment of obesity - update on the ongoing clinical trials.
Trial report in Obesity surgery, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed.
- Implantable gastric stimulator does not prevent the increase in plasma ghrelin levels that occurs with weight loss.Obesity (Silver Spring, Md.) · 2011Trial
- Improvement in glycemic control by gastric electrical stimulation (TANTALUS) in overweight subjects with type 2 diabetes.Surgical endoscopy · 2009Trial
- The Role of Minimally Invasive and Endoscopic Technologies in Morbid Obesity Treatment: Review and Critical Appraisal of the Current Clinical Practice.Obesity surgery · 2020Review
- Standardization of Bariatric Metabolic Procedures: World Consensus Meeting Statement.Obesity surgery · 2019Article
- Design and Implementation of a Less Invasive Gastrostimulator.European journal of translational myology · 2016Article
- Gastric electrical stimulation optimized to inhibit gastric motility reduces food intake in dogs.Obesity surgery · 2015Article
- Neurostimulation of the gastrointestinal tract: review of recent developments.Neuromodulation : journal of the International Neuromodulation Society · 2015Review
- Updates on gastric electrical stimulation to treat obesity: Systematic review and future perspectives.World journal of gastrointestinal endoscopy · 2014Article
- Parameter selection and stimulating effects of an adjustable gastric electrical stimulator in dogs.Obesity surgery · 2014Article
- Food intake and body weight responses to intermittent vs. continuous gastric electrical stimulation in diet-induced obese rats.Obesity surgery · 2013Article
- An update on less invasive and endoscopic techniques mimicking the effect of bariatric surgery.Journal of obesity · 2012Article
- Effects and mechanisms of electrical stimulation of the stomach, duodenum, ileum, and colon on gastric tone in dogs.Digestive diseases and sciences · 2010Article
- Neuromodulatory processes of the brain-gut axis.Neuromodulation : journal of the International Neuromodulation Society · 2008Article
- Surgery for obesity: a review of the current state of the art and future directions.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2007Review
- Electrical stimulation as treatment for obesity and diabetes.Journal of diabetes science and technology · 2007Article
- Laparoscopically implanted gastric pacemaker after kidney-pancreas transplantation: treatment of morbid obesity and diabetic gastroparesis.Obesity surgery · 2007Article
- Gastric electrical stimulation: an evidence-based analysis.Ontario health technology assessment series · 2006Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe prevalence of obesity is growing worldwide. Medical therapies are often ineffective, and surgical treatments have significant risk. IGS(R) offers a novel approach to weight loss that was found to be safe and effective in European trials. In the U.S., 2 consecutive trials have been undertaken.
methodsIn 2000, a multicenter, prospective, randomized, placebo-controlled trial involving 103 morbidly obese patients (U.S. O-01) was undertaken. In 2002, a prospective, open label trial involving 30 morbidly obese patients was initiated (DIGEST). Patients were followed for complications, postoperative untoward events, and weight loss.
resultsIn O-01, there were no significant perioperative complications. However, 20 patients were found to have had lead dislodgements. At 7 months, there was no significant difference in weight loss between the activated and non-activated groups. After 29 months, loss of excess weight (EWL) approached 20%. With DIGEST, there was 1 operative complication (a lost needle retrieved surgically). There were no untoward events or known lead dislodgements. EWL was 23% after only 16 months follow-up. With the introduction of a preoperative screening algorithm, almost 40% EWL was achieved for selected patients in both trials.
conclusionsIn the U.S., the IGS system for the treatment of obesity has been shown to be safe. Technical improvements and better patient selection resulted in improved weight loss. The preliminary results of these trials suggest that IGS may be a suitable surgical option for selected patients.
Indexed as
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.