LevaLap 1.0在腹腔镜下使用的临床随访研究。

IF 1.4 4区 医学 Q3 SURGERY
Xavier Deffieux, Jean-Louis Benifla, Ingolf Juhasz-Böss, Moritz Breitbach, Olaf Buchweitz, Nassir Habib, Kirsten Hald, Bashar Haj Hamoud, Cyrille Huchon, Vibeke Lysdal, Meletios P Nigdelis, Martin Rudnicki, Erich-Franz Solomayer, Florin-Andrei Taran, Henrik Michelsen-Wahl, Ricardo Azziz, Vincenzo Bagnardi, Andreas Hackethal
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引用次数: 0

摘要

背景和目的:LevaLap 1.0 (Core Access Surgical Technologies, Atlanta, GA)旨在促进使用Veress针进行充气时更安全、更稳定和更可预测的腹部通道。我们报告了首个上市后临床研究(PMCF)评估在妇科腹腔镜手术中使用LevaLap 1.0的经验。方法:前瞻性多中心研究,纳入年龄≥18岁的女性,排除妊娠、10天前进行过手术、腹部疝、使用Veress针或腹腔镜的禁忌症、体重指数(BMI) bb0 ~ 30 kg/m2、不能/不愿提供同意。结果:共纳入158例受试者,包括9名外科医生。平均年龄43.6±14.6岁,平均BMI: 24.7±3.8 kg/m2。83.5%为经脐,15.2%为脐周,1.2%为其他部位。使用该设备,96.8%(95%置信区间[CI]: 92.8-99.0%, n = 152/157)的患者在第一次尝试中获得成功,99.4% (95% CI: 96.5-100.0, n = 156/157)的患者在前两次尝试中获得成功。报告了一个与器械相关的轻微不良事件:器械应用部位皮肤出现圆形红肿,自发消退。59.5%的医生认为更容易进入,68.3%的医生认为更有信心进入,67.1%的医生认为更容易进入,66.4%的医生认为更有效率。结论:本PMCF研究表明,在使用Veress针进行腹部穿刺时,使用LevaLap 1.0更容易、更好地控制和更高的效率。96.8%的人在第一次尝试中获得了访问,99.4%的人在前两次尝试中获得了访问。当使用Veress针进行充气时,使用LevaLap 1.0可以方便腹部进入。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Post-Market Clinical Follow-Up Study of the LevaLap 1.0 during Laparoscopic Access.

Background and objectives: The LevaLap 1.0 (Core Access Surgical Technologies, Atlanta, GA) was designed to promote safer, more stable, and more predictable abdominal access when using the Veress needle for insufflation. We report on the first postmarket clinical study (PMCF) assessing experience with the use of the LevaLap 1.0 during gynecologic laparoscopic surgery.

Methods: Prospective multicenter study, including women ≥18 years old, excluding pregnancy, access site surgery in prior 10 days, abdominal hernia, contraindication to Veress needle or laparoscopy use, body mass index (BMI) >30 kg/m2, and inability/unwillingness to provide consent.

Results: A total of 158 subjects were included, involving nine surgeons. Mean age was 43.6 ± 14.6 years and mean BMI: 24.7 ± 3.8 kg/m2. Access site was 83.5% transumbilical, 15.2% periumbilical, and 1.2% other. Using the device 96.8% (95% confidence interval [CI]: 92.8-99.0%, n = 152/157) of patients' access was successfully achieved at first attempt and 99.4% (95% CI: 96.5-100.0, n = 156/157) within the first 2 attempts. One minor device-related adverse event was reported: a circular redness on the skin at the site of device application, resolving spontaneously. Surgeons noted easier access in 59.5%, increased confidence in 68.3%, increased access control in 67.1%, and increased access efficiency in 66.4% of cases.

Conclusion: This PMCF study indicates that the use of the LevaLap 1.0 resulted in easier, greater control and greater efficiency during abdominal access using the Veress needle. In 96.8% access was achieved at first attempt and in 99.4% within the first 2 attempts. The use of the LevaLap 1.0 may facilitate abdominal access when using the Veress needle for insufflation.

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来源期刊
CiteScore
2.40
自引率
0.00%
发文量
69
审稿时长
4-8 weeks
期刊介绍: JSLS, Journal of the Society of Laparoscopic & Robotic Surgeons publishes original scientific articles on basic science and technical topics in all the fields involved with laparoscopic, robotic, and minimally invasive surgery. CRSLS, MIS Case Reports from SLS is dedicated to the publication of Case Reports in the field of minimally invasive surgery. The journals seek to advance our understandings and practice of minimally invasive, image-guided surgery by providing a forum for all relevant disciplines and by promoting the exchange of information and ideas across specialties.
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