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

NCT02702531 | Completed Phase 4

• 1 other identifier: 2015-A01421-48
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

The Performance Evaluations of the FloShield Defogging and Cleaning System

Keywords

Laparoscopic Surgery; FloShield Defogging and Cleaning System; Clearify Defogging and Cleaning System; gynecologic

Outcome Measures

Primary Outcomes (1)

• number of Laparoscope removals during surgery

  0.5hr - 6hr

Secondary Outcomes (2)

• medico economic cost effectiveness of the system

  0.5hr - 6hr

• Evaluation of the quality of vision by the surgeon and his assistant end of the procedure using a visual analog scale

  0.5hr - 6hr

Study Arms (2)

FloShield

EXPERIMENTAL

FloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery

Device: FloShield Defogging and Cleaning System

Water + Povidone-iodine Solution

EXPERIMENTAL

Clearify Visualization with Water + Povidone-iodine Solutionused during laparoscopic surgery

Device: FloShield Defogging and Cleaning System

Interventions

FloShield Defogging and Cleaning System DEVICE

FloShield; Water + Povidone-iodine Solution

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or Male; 18 years of age or older; Patient scheduled for gynecologic paroscopic surgery under the care of the study investigator; Suitable candidate for surgery

You may not qualify if:

• Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator); Use of Surgiquest AirSeal®; Use of humidified insufflation

Sponsors & Collaborators

• Tenon Hospital, Paris: lead

Study Sites (1)

Aphp, Tenon Hospital

Paris, Paris /france, 75020, France

Location

Related Publications (1)

• Bendifallah S, Salakos E, Naoura I, Aristizabal P, Furet E, Zilberman S, Ballester M, Darai E. Prospective, randomized comparison of the use of FloShield Air System(R) versus the reference technique (water + povidone-iodine solution) during gynecologic endoscopic surgery to evaluate the operative lens vision quality. Surg Endosc. 2018 Mar;32(3):1593-1599. doi: 10.1007/s00464-017-5642-6. Epub 2017 Jun 22.

  PMID: 28643058 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 8, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 20, 2016

Record last verified: 2016-10

Locations

FR (1)