title: [Evaluation of a Micro-Manipulator for Middle Ear Surgery: A Preclinical Trial].
abstract: BACKGROUND
  Microsurgical preparation is limited by geometric and mechanical constraints. In preparation for clinical use, this study investigates performance, ease of handling and precision of a novel manipulator concept for microsurgery.
  
  
  METHODS
  A group of 15 ENT experienced doctors, as well as a group of 17 medical students with low/non surgical experience participated in the study. Each of the subjects carried out 4 trials of simulated surgeries on a phantom with built-in force sensors. The task was to apply a defined force between 1.5 and 2 N using a Fisch micro perforator, 16 cm length, 0.4 mm (Storz) targeting holes with a diameter of 0.5 mm. For comparison, the Fisch micro perforator was moved manually or with the manipulator.
  
  
  RESULTS
  Assessing the total number of errors proved a significantly lower error number (p<0.0001) and an improvement of the accuracy of 76% with the manipulator. The time requirement for the procedure with the micro manipulator is on average 2-3 times higher than with manual control (p<0.0001). But it is notable that this time requirement significantly decreases with training (p<0.0001).
  
  
  CONCLUSIONS
  The study shows a significant reduction in the number of errors by using a new manipulator concept compared to the non-augmented human hand in an experimental setup. We observed a significant learning effect when subjects applied the micro manipulator, resulting in reduction of the time requirement while maintaining a constant number of errors.
authors.affiliation: Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Universitätsklinikum Leipzig AöR, Leipzig.
authors.forename: A
authors.initials: A
authors.lastname: Peschka
authors.affiliation: Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Universitätsklinikum Leipzig AöR, Leipzig.
authors.forename: Th
authors.initials: T
authors.lastname: Berger
authors.affiliation: Mikrotechnik und Medizingerätetechnik (MiMed), Technische Universität München, Garching b. München.
authors.forename: Th
authors.initials: T
authors.lastname: Maier
authors.affiliation: IMISE, Institut für Medizinische Informatik, Statistik und Epidemiologie, Universität Leipzig, Leipzig.
authors.forename: M
authors.initials: M
authors.lastname: Scholz
authors.affiliation: Lehrstuhl für Mikro- und Medizingerätetechnik (MiMed), Technische Universität München, Garching b. München.
authors.forename: T C
authors.initials: TC
authors.lastname: Lüth
authors.affiliation: ICCAS, Innovation Center Computer Assisted Surgery.
authors.forename: G
authors.initials: G
authors.lastname: Strauß
mesh_terms: D000328:Adult; D004432:Ear, Middle / Q000601:surgery*; D005260:Female; D006801:Humans; D059032:Learning Curve; D008297:Male; D019300:Medical Errors / Q000517:prevention & control; D008846:Micromanipulation / Q000295:instrumentation*; D008953:Models, Anatomic; D061646:Operative Time; D009998:Ossicular Prosthesis; D010033:Otitis Media / Q000601:surgery*; D010036:Otolaryngology / Q000193:education; D010040:Otosclerosis / Q000601:surgery*; D065287:Robotic Surgical Procedures / Q000295:instrumentation*; D013201:Stapes Surgery / Q000295:instrumentation*; D013337:Students, Medical; D025321:Surgery, Computer-Assisted / Q000295:instrumentation*; D013523:Surgical Equipment; D017216:Telemedicine / Q000295:instrumentation