BACKGROUND: Laparoscopic fundoplication provides good reflux control, but side-effects due to the surgical procedure are known. Different endoluminal techniques have been introduced, but all with disappointing results. OBJECTIVE: Evaluation of the feasibility and safety of a new device, which enables a totally endoluminal anterior fundoplication for the treatment of gastroesophageal reflux disease (GERD). MATERIAL: The device is a modified video gastroscope, which incorporates a surgical stapler (using standard 4.8 B-shaped surgical staples) and an ultrasonic sight. The cartridge is mounted on the shaft and the anvil is at the tip. This enables accurate stapling of the fundus to the esophagus, using the ultrasonic sight to guide distance and alignment of the anvil and the cartridge. METHOD: Sixteen female swine of mixed breed were used in the study; 12 underwent the endoscopic procedure, and 4 were used a controls to monitor weight gain. The 12 study animals were sacrificed at 2, 4, and 8 weeks (4 pigs each time) and visually inspected for complications, healing, and fundoplication. The study was sponsored by MediGus Ltd. and monitored for compliance with good laboratory practice (GLP) regulations by an external company (Econ Inc.), which is GLP certified by the German Federal Government. It was conducted at the animal testing facility of the Charité Virchow Clinic in Berlin. RESULTS: The procedure went smoothly in all pigs; median procedure time was 12 min (range 9-35 min). At sacrifice, the stapled area had healed well, all animals had a satisfactory 180° anterolateral fundoplication, and there were no procedure-related complications. CONCLUSIONS: Creating a satisfactory anterior fundoplication with the new device is feasible, easy, and safe. Proof of efficacy must await clinical trials, which are underway.
BACKGROUND: Laparoscopic fundoplication provides good reflux control, but side-effects due to the surgical procedure are known. Different endoluminal techniques have been introduced, but all with disappointing results. OBJECTIVE: Evaluation of the feasibility and safety of a new device, which enables a totally endoluminal anterior fundoplication for the treatment of gastroesophageal reflux disease (GERD). MATERIAL: The device is a modified video gastroscope, which incorporates a surgical stapler (using standard 4.8 B-shaped surgical staples) and an ultrasonic sight. The cartridge is mounted on the shaft and the anvil is at the tip. This enables accurate stapling of the fundus to the esophagus, using the ultrasonic sight to guide distance and alignment of the anvil and the cartridge. METHOD: Sixteen female swine of mixed breed were used in the study; 12 underwent the endoscopic procedure, and 4 were used a controls to monitor weight gain. The 12 study animals were sacrificed at 2, 4, and 8 weeks (4 pigs each time) and visually inspected for complications, healing, and fundoplication. The study was sponsored by MediGus Ltd. and monitored for compliance with good laboratory practice (GLP) regulations by an external company (Econ Inc.), which is GLP certified by the German Federal Government. It was conducted at the animal testing facility of the Charité Virchow Clinic in Berlin. RESULTS: The procedure went smoothly in all pigs; median procedure time was 12 min (range 9-35 min). At sacrifice, the stapled area had healed well, all animals had a satisfactory 180° anterolateral fundoplication, and there were no procedure-related complications. CONCLUSIONS: Creating a satisfactory anterior fundoplication with the new device is feasible, easy, and safe. Proof of efficacy must await clinical trials, which are underway.
Authors: C J Filipi; G A Lehman; R I Rothstein; I Raijman; G V Stiegmann; J P Waring; J G Hunter; C J Gostout; S A Edmundowicz; D P Dunne; P A Watson; D A Cornet Journal: Gastrointest Endosc Date: 2001-04 Impact factor: 9.427
Authors: C Feretis; P Benakis; C Dimopoulos; A Dailianas; P Filalithis; K M Stamou; A Manouras; N Apostolidis Journal: Gastrointest Endosc Date: 2001-04 Impact factor: 9.427
Authors: R J Mason; C J Filipi; T R DeMeester; J H Peters; R J Lund; A W Flake; R A Hinder; T C Smyrk; C G Bremner; S Thompson Journal: Gastrointest Endosc Date: 1997-03 Impact factor: 9.427
Authors: P Fockens; M J Bruno; A Gabbrielli; S Odegaard; J Hatlebakk; H D Allescher; T Rösch; M Rhodes; C Bastid; J Rey; J Boyer; S Muehldorffer; U van den Hombergh; G Costamagna Journal: Endoscopy Date: 2004-08 Impact factor: 10.093
Authors: Douglas Pleskow; Richard Rothstein; Simon Lo; Robert Hawes; Richard Kozarek; Gregory Haber; Christopher Gostout; Anthony Lembo Journal: Gastrointest Endosc Date: 2004-02 Impact factor: 9.427
Authors: Guy-Bernard Cadière; Michel Buset; Vinciane Muls; Amin Rajan; Thomas Rösch; Alexander J Eckardt; Joseph Weerts; Boris Bastens; Guido Costamagna; Michele Marchese; Hubert Louis; Fazia Mana; Filip Sermon; Anna K Gawlicka; Michael A Daniel; Jacques Devière Journal: World J Surg Date: 2008-08 Impact factor: 3.352
Authors: Johannes Zacherl; Aviel Roy-Shapira; Luigi Bonavina; Amol Bapaye; Ralf Kiesslich; Sebastian F Schoppmann; William R Kessler; Don J Selzer; Ryan C Broderick; Glen A Lehman; Santiago Horgan Journal: Surg Endosc Date: 2014-08-19 Impact factor: 4.584