跳至主要内容
临床试验/NCT02702531
NCT02702531已完成4 期

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

Tenon Hospital, Paris2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年3月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
number of Laparoscope removals during surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

number of Laparoscope removals during surgery

时间窗: 0.5hr - 6hr

次要结局

  • Evaluation of the quality of vision by the surgeon and his assistant end of the procedure using a visual analog scale(0.5hr - 6hr)
  • medico economic cost effectiveness of the system(0.5hr - 6hr)

研究者

发起方
Tenon Hospital, Paris
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pr. Emile Darai

MD, PhD

Tenon Hospital, Paris

研究点 (2)

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