A Comparison of Industry Leading Energy Devices for Use in Gynecologic Laparoscopy: Articulating Enseal Versus Ligasure Energy Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 4
- 主要终点
- Raw Task Load Index (TLX) Score Assigned by Surgeons
研究概览
简要总结
This is an exploratory study to assess the ability of the raw-TLX (raw Task Load Index) ergonomic assessment tool to detect differences in surgeon workload when using commercially available advanced bipolar devices. It is anticipated that the raw-TLX version of the validated NASA-TLX ergonomic assessment tool will detect less surgeon effort required in the procedure when articulating ENSEAL is utilized. The Articulating ENSEAL device may also positively impact other variables such as blood loss, operative time and cost.
详细描述
This study is a single-center, single-blinded, randomized control, pilot trial that will be conducted at the University of Louisville Hospital. It is designed to assess whether there are different surgical outcomes with regard to surgeon perception of ease of instrument use, operative time, estimated blood loss, cost and perioperative complication rates between the Ethicon Articulating Enseal versus the LigaSure for total laparoscopic hysterectomy. This will be assessed using the raw-TLX version of the validated NASA-TLX scale.
The study will be single-blinded in that the patient will not be informed of their group assignment; it is impossible to blind the surgeon using the devices.
Methods and Procedures:
Patients undergoing total laparoscopic hysterectomy will be recruited from our University of Louisville Health Care Outpatient Center (HCOC) outpatient office and will be consented for participation in the study during their preoperative office visit.
Patients will be randomized pre-operatively on their date of surgery to one of two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Able and willing to provide informed consent
- •Undergoing total laparoscopic hysterectomy
排除标准
- •Under 18 years of age
- •Severe endometriosis or adhesions requiring >15min of adhesiolysis prior to beginning hysterectomy
- •Unsafe to use energy device due to decreased visualization or any other reason deemed to be unsafe by the surgeon intra-operative decision to convert to laparotomy prior to use of energy device
- •Current diagnosis of uterine, tubal ovarian or cervical malignancy.
- •Patients who cannot read/understand English.
研究组 & 干预措施
articulating Enseal
This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.
干预措施: articulating Enseal (Device)
Ligasure device
This group of women undergoing hysterectomy is randomized to the Ligasure energy device.
干预措施: Ligasure device (Device)
结局指标
主要结局
Raw Task Load Index (TLX) Score Assigned by Surgeons
时间窗: 18 months
The Official NASA Task Load Index (TLX) is a subjective workload assessment tool to allow users to perform subjective workload assessments on operator(s) working with various human-machine interface systems. By incorporating a multi-dimensional rating procedure, NASA TLX derives an overall workload score based on a weighted average of ratings on six subscales given below. The overall workload score ranges between 0 and 100 with 100 being the most demanding. Mental Demand Physical Demand Temporal Demand Performance Effort Frustration
次要结局
- Intra- and Post-operative Complications(18 months)
- Estimated Blood Loss(18 months)
- Need for Second Energy Device Intra-operatively(18 months)
- Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.(During procedure)
- Time Required to Complete Procedure(End of surgery up to 4 hours)
研究者
Resad Pasic
Professor with Tenure of Obstetrics and Gynecology
University of Louisville