title: Transvaginal cholecystectomy without laparoscopic support using prototype flexible endoscopic instruments in a porcine model.
abstract: BACKGROUND
  Transvaginal cholecystectomy with laparoscopic assistance has been performed safely in humans. The next goal was to develop a natural orifice transluminal endoscopic surgery (NOTES) technique to perform cholecystectomy without laparoscopic instruments using one flexible endoscope and flexible accessories. The aim of the study was to test the feasibility of the procedure in a survival porcine model.
  
  
  METHODS
  Cholecystectomies were attempted in five 88-130-lb. pigs with a planned 2-week survival. Prototype flexible instruments (NOTES Toolbox, Ethicon Endo-Surgery, Inc.) were used to aid in access, dissection, and removal of the gallbladder via the transvaginal route.
  
  
  RESULTS
  Cholecystectomy could be completed without abdominal incision using prototype instruments in four out of five pigs. The cystic duct could be exposed with a flexible hook knife and clips applied. The steerable trocar improved stability and the precision of the dissection. The critical view was established in all five pigs. Dissection of the gallbladder off the liver bed was imprecise resulting in gallbladder perforation in all pigs and liver hemorrhage in two. At necropsy, all clips on the cystic duct were secure and no bile leak, bowel injury, or adhesions were present.
  
  
  CONCLUSIONS
  NOTES cholecystectomy without laparoscopic support is feasible but challenging using prototype flexible endoscopic devices. A prototype clip applier was effective in controlling the cystic duct. Further improvements in instrument design to ensure precision and safety are needed before flexible devices should be used for pure NOTES procedures in humans.
authors.affiliation: Department of Surgery, University of Missouri, One Hospital Drive, Columbia, MO 65212, USA.
authors.forename: Shean
authors.initials: S
authors.lastname: Satgunam
authors.forename: Brent
authors.initials: B
authors.lastname: Miedema
authors.forename: Susan
authors.initials: S
authors.lastname: Whang
authors.forename: Klaus
authors.initials: K
authors.lastname: Thaler
mesh_terms: D000818:Animals; D002763:Cholecystectomy / Q000295:instrumentation* / Q000379:methods; D019723:Endoscopes; D016145:Endoscopy, Digestive System / Q000295:instrumentation*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D008488:Medical Illustration; D057605:Natural Orifice Endoscopic Surgery / Q000295:instrumentation* / Q000379:methods; D013525:Surgical Instruments; D034421:Sus scrofa; D014621:Vagina