Initial Clinical Experience With the ENSEAL® G2 Articulating Tissue Sealer in Laparoscopic Colectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Number of articulated activations
研究概览
简要总结
The primary objective of this clinical study is to describe the initial clinical experience with ENSEAL® G2 Articulating Tissue Sealer in laparoscopic colectomy, quantifying and/or qualifying how its articulation feature enables optimization of vessel sealing through improved access, approach, and visibility. This is an observational study of device usage being conducted to report initial experience with the ENSEAL ART device. It is not intended as hypothesis testing.
详细描述
The ENSEAL® G2 Tissue Sealer is a sterile, single-patient use surgical instrument used to coagulate and transect vessels up to and including 7mm in diameter and tissue and/or vascular bundles. In preclinical research using ENSEAL tissue sealers, burst pressures were 51% higher for perpendicularly sealed vessels than for angled seals (p<0.001) and the seal length was the primary variable in determining burst pressure (Voegele AC, 2013). These results suggest that the strongest possible seal may be obtained when vessels are approached perpendicularly and not at an angle.
However, desired angles for vessel sealing cannot always be obtained in the surgical field, especially in laparoscopic surgery due mostly to the fixed nature of the abdominal wall cannulas and the lack of adequate articulating hemostatic tools.
Since strong vessel seals are important for adequate homeostasis, the value of an articulating vessel-sealing device primarily resides in its ability to maneuver around corners and behind structures in confined spaces. An articulating vessel-sealing device would maximize the ability to approach vessels or bundles in a perpendicular manner to provide greater seal strength.
ENSEAL ART is the first articulating advanced bipolar device that can facilitate laparoscopic surgery through a 5mm port. The instrument shaft, can achieve up to 110 degrees of articulation (which improves the visibility of the tip of the device's jaw) to gain access to tissue in challenging anatomy, especially in deep/tight spaces, and facilitate additional angles to transect and seal tissue, vessels, and vascular bundles.
The articulation feature and improved ergonomics of the ENSEAL ART may provide the ability to maneuver around corners and behind structures, while making it easier to capture the full vessel in a single bite. These features may lead to a reduction of the number of ports, the instrument exchanges between ports, the need to pass the energy device to an assistant, and the number of times the surgical table tilt has to be changed during certain laparoscopic surgical procedures (e.g., colectomy).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants (age ≥ 18 and < 80 years of age, on the day of the procedure
- •Scheduled to undergo one of the following planned colectomies, anticipated to be performed laparoscopically:
- •a. Right colectomy; b. Left hemicolectomy; c. Transverse colectomy; d. Sigmoidectomy; e. Total colectomy; or f. Subtotal colectomy. f. Subtotal colectomy.
排除标准
- •Unable or unwilling to sign the study informed consent form;
- •Previous colectomy and/or proctectomy;
- •Anticipated combinations of laparoscopic colectomy and low anterior resection, except in cases in which the lower anterior resection is intended to be done with an energy device other than the ENSEAL® G2 Articulating Tissue Sealer;
- •Any previous major surgery of the colon that, in the opinion of the surgeon, may increase the risk of intraoperative conversion to open surgery;
- •Surgery planned to be performed using a single port;
- •Surgery planned to be performed with a hand-assisted device;
- •Requiring emergency surgery;
- •Likely to require an energy tissue sealer/dissector with a shaft larger than 35cm during surgery;
结局指标
主要结局
Number of articulated activations
时间窗: Intraoperative
Number of device activations while the device is articulated
次要结局
未报告次要终点
