The Performance Evaluations of the FloShield Defogging and Cleaning System Clinical Trial
Official title:
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
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment