Andras Legner1, Aron Altorjay1, Arpad Juhasz1, Rudolph Stadlhuber2, Viktor Reich3, Brandon Hunt4, Richard Rothstein5, Charles Filipi6. 1. Saint George University Teaching Hospital, Szekesfehervar, Hungary. 2. Klinikum Nuremberg, Nuremberg, Germany. 3. Creighton University School of Medicine, Omaha, NE, USA. 4. SafeStitch Medical Inc, Miami, FL, USA. 5. Dartmouth Medical School, Lebanon, NH, USA. 6. Creighton University School of Medicine, Omaha, NE, USA SafeStitch Medical Inc, Miami, FL, USA cjf@safestitch.com.
Abstract
INTRODUCTION: An outpatient transoral endoscopic procedure for gastroesophageal reflux disease (GERD) and obesity would be appealing if safe, effective, and durable. We present the first in human experience with a new system. METHODS: Eight patients with GERD (3) and obesity (5) were selected according to a preapproved study protocol. All GERD patients had preprocedure manometry and pH monitoring to document GERD as well as quality of life and symptom questionnaires. Obese patients (body mass index >35) underwent a psychological evaluation and tests for comorbidities. Under general anesthesia, a procedure was performed at the gastroesophageal junction including mucosal excision, suturing of the excision beds for apposition, and suture knotting. RESULTS: One patient with micrognathia could not undergo the required preprocedural passage of a 60 F dilator and was excluded. The first 2 GERD patients had incomplete procedures due to instrument malfunction. The subsequent 5 subjects had a successfully completed procedure. Four patients were treated for obesity and had an average excess weight loss of 30.3% at 2-year follow-up. Of these patients, one had an 8-mm outlet at the end of the procedure recognized on video review--a correctable error--and another vomited multiple times postoperatively and loosened the gastroplasty sutures. The treated GERD patient had resolution of reflux-related symptoms and is off all antisecretory medications at 2-year follow-up. Her DeMeester score was 8.9 at 24 months. CONCLUSION: The initial human clinical experience showed promising results for effective and safe GERD and obesity therapy.
INTRODUCTION: An outpatient transoral endoscopic procedure for gastroesophageal reflux disease (GERD) and obesity would be appealing if safe, effective, and durable. We present the first in human experience with a new system. METHODS: Eight patients with GERD (3) and obesity (5) were selected according to a preapproved study protocol. All GERDpatients had preprocedure manometry and pH monitoring to document GERD as well as quality of life and symptom questionnaires. Obesepatients (body mass index >35) underwent a psychological evaluation and tests for comorbidities. Under general anesthesia, a procedure was performed at the gastroesophageal junction including mucosal excision, suturing of the excision beds for apposition, and suture knotting. RESULTS: One patient with micrognathia could not undergo the required preprocedural passage of a 60 F dilator and was excluded. The first 2 GERDpatients had incomplete procedures due to instrument malfunction. The subsequent 5 subjects had a successfully completed procedure. Four patients were treated for obesity and had an average excess weight loss of 30.3% at 2-year follow-up. Of these patients, one had an 8-mm outlet at the end of the procedure recognized on video review--a correctable error--and another vomited multiple times postoperatively and loosened the gastroplasty sutures. The treated GERDpatient had resolution of reflux-related symptoms and is off all antisecretory medications at 2-year follow-up. Her DeMeester score was 8.9 at 24 months. CONCLUSION: The initial human clinical experience showed promising results for effective and safe GERD and obesity therapy.
Authors: Reginald C W Bell; Peter G Mavrelis; William E Barnes; David Dargis; Bart J Carter; Kevin M Hoddinott; Robert W Sewell; Karim S Trad; Brian DaCosta Gill; Glenn M Ihde Journal: J Am Coll Surg Date: 2012-08-29 Impact factor: 6.113
Authors: Richard Rothstein; Charles Filipi; Karel Caca; Ronald Pruitt; Klaus Mergener; Alfonso Torquati; Gregory Haber; Yang Chen; Kenneth Chang; David Wong; Jacques Deviere; Douglas Pleskow; Charles Lightdale; Alain Ades; Richard Kozarek; William Richards; Anthony Lembo Journal: Gastroenterology Date: 2006-09 Impact factor: 22.682
Authors: D von Renteln; I Schiefke; K H Fuchs; S Raczynski; M Philipper; W Breithaupt; K Caca; H Neuhaus Journal: Surg Endosc Date: 2009-05-14 Impact factor: 4.584
Authors: Peter N Meier; Tina Nietzschmann; Ibrahim Akin; Stefanie Klose; Michael P Manns Journal: Scand J Gastroenterol Date: 2007-08 Impact factor: 2.423
Authors: Francesco Maria Carrano; Miroslav P Peev; John K Saunders; Marcovalerio Melis; Valeria Tognoni; Nicola Di Lorenzo Journal: Obes Surg Date: 2020-02 Impact factor: 4.129