Prospective, Randomized Comparison of the Use of FloShield Air System ® Versus the Referenced Technic (Water + Povidone-Iodine Solution) During Gynecologic Endoscopic Surgery to Evaluate the Operative Lens Vision Quality
Condition: The Performance Evaluations of the FloShield Defogging and Cleaning System
Study type: Interventional
Phase: Phase 4

Summary: 
      Endoscopic surgical procedures are becoming more common in all surgical specialties including
      gynecology that was one of the pioneers in this field specialties.

      Maintaining a quality field of view is important not only to patient safety but also for the
      quality of surgery and reduced surgery time.

      The lenses of vision which are located at the distal end of the optical vision are during
      endoscopic surgery in direct contact with the anatomical structures. These lenses are found
      soiled by several phenomena whose appearance of a mist which constitutes a major obstacle to
      a clear field.

      The alteration of the vision requires the surgeon extraction optics in order to achieve a
      cleaning of the lens. This cleaning is carried out as many times as necessary. Many
      strategies have been developed to improve the quality of vision. These methods relate to both
      the development of new optical vision but also the development of the lens cleaning material.
      In practice, the cleaning is carried out using a sterile swab sterile saline associated with
      the betadine iodine.

      Recently a new material called "FloShield Air System Vision System" has been proposed and has
      the particularity to combine both anti-fog product and a temperature control system in
      contact with the lens in order to fight against condensation and smoke. The purpose of this
      is to improve the quality of vision by reducing the fogging phenomenon and no change of the
      temperature in contact with the lens (moisture reduction). Accordingly, it is assumed a
      reduction in the number of stay and a reduction in the specific operative time associated
      with this cleaning.

      In this context, we wish to evaluate the effectiveness of FloShield Air System vision system
      on the basis of a comparative, prospective, randomized against the reference method (sterile
      water solution + Betadine) during endoscopic surgery gynecology.
    

Detailed description: 
      The reduction in vision during endoscopic surgery is a common problem for all surgical
      specialties and recurring. Studies of the pathophysiological mechanisms explaining the visual
      impairment by fogging emphasize the role of intraperitoneal temperature and moisture in
      contact with the optical lens. To this can be added two other causes of impaired vision are
      fluid projections and passively encountered tissues during exploration (eg, blood, fat, and
      ascites) and products of reactions of tissue during surgery for example, the outcome of smoke
      using coagulation material or section. In these situations the vision may be impaired in
      critical times during which an optimal view is needed to improve the quality of surgery.

      A report by the World Health Organization was intended to identify the consequences of
      impaired vision during laparoscopic surgery. It is emphasized that impaired vision can
      contribute to surgical errors such as the use of a device incorrectly or displacement of the
      instruments on structures other than those intended. Moreover, it is reported an increase in
      the operative time associated with suboptimal view. Finally, the psychological dimension on
      the disruption of the surgeon is raised with a risk of difficulty of the procedure. To
      minimize these problems anti mist vision solutions combined with condensed water vapor spray
      system are among others marketed in recent years.

      The action mechanism of these systems is to distribute steam droplets condensed on the
      surface of the cold lens to improve the quality of vision. Most, however, require cleaning of
      optics, but with less theoretical frequency. Although their use is reported in the literature
      their use has never been evaluated on the basis of a robust methodology.

      Alternative methods readily available such as povidone iodine act similarly and are
      significantly less expensive (at least 10 times) than the above mentioned materials. No
      comparative study is currently available to support the effectiveness of these materials to
      the reference method inexpensive but partially effective. Their use is based solely on
      experience and expert opinion.

      Vision device "FloShield Air System" was developed. We offer a comparative evaluation of the
      effectiveness of FloShield Air System vision system on the basis of a comparative,
      prospective, randomized against the reference method (sterile water + Betadine) during a
      gynecologic endoscopic surgery.

      We propose to carry out a single-center, randomized, prospective trial comparing the efficacy
      in terms of reducing the number of cleaning FloShield Air System vision system, from a
      prospective, randomized during endoscopic surgery in gynecology.

      After evaluation of the International Register of Clinical Trials Registry
      (https://clinicaltrials.gov/ct2/about-site) of the National Institutes of Health American no
      ongoing trial or released is interested or not interested at effectiveness of FloShield Air
      System vision device during endoscopic surgery in gynecology specifically on the primary
      endpoint.

      Currently, the only Recruiting trial which concerns the system is entitled "Comparison
      FloShield Air System Versus clearify Visualization System (D-HELP)) (NCT02419911)." This is a
      non-academic comparative prospective trial efficiency.

      The originality of our protocol resides in five points:

        -  His academic nature: the promoter is the University Hospital Tenon Hospital (AP-HP)

        -  It attempts to answer a clinical question frequently in clinical practice

        -  The feasibility: experience and surgical volume recruiting center in the endoscopic
           management should help support the computing power.

        -  Its safety for the patient

        -  The methodological basis helps support a level I evidence for this new material
    

Intervention name(s): FloShield Defogging and Cleaning System
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopic Surgery; FloShield Defogging and Cleaning System; Clearify Defogging and Cleaning System; gynecologic