Effectiveness of a Universal Self-Locking Uterine Manipulator Stand in Hysterectomy：a Single-center,Single-blind, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative Fatigue
研究概览
简要总结
The primary goal of this clinical trial is to evaluate whether a Universal Self-Locking Uterine Manipulator Stand can reduce the level of fatigue experienced by clinicians during total hysterectomy.The key question it aims to answer is:
• Can the Universal Self-Locking Uterine Manipulator Stand reduce surgeon fatigue during intraoperative uterine manipulation? Participants will be randomly assigned to either the experimental group or the control group. In the experimental group, the Universal Self-Locking Uterine Manipulator Stand will be utilized during surgery, whereas in the control group, an assistant surgeon will perform uterine manipulation manually using a standard uterine manipulator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
In this study, a single-blinded design was employed where the enrolled patients were blinded, while the operating surgeons could not be blinded.
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
- 否
入选标准
- •Medical Staff:
- •Possess a national medical license (doctors) or registered nurse qualification (nurses)
- •Doctors: have obtained corresponding surgical qualifications through the hospital's endoscopic surgery grading system
- •Nurses: have at least 5 years of operating room experience at the study hospital
- •All surgical procedures are performed by a consistent surgical team
- •Surgical Patients:
- •Age 18 to 75 years
- •Undergoing tracheal intubation general anesthesia
- •No contraindications for uterine manipulation
- •Willing to participate voluntarily and provide written informed consent
排除标准
- •Preoperative B-ultrasound indicating uterine size ≥ 4 months
- •Cervical treatment surgery within the past 3 months
- •Failed placement of the uterine support device
- •Need for intraoperative conversion to a different surgical method
- •Need for intraoperative removal of the auxiliary uterine support device due to special circumstances
研究组 & 干预措施
Universal self-locking uterine manipulator stand
The intervention in the experimental group included: ① Preoperative training for doctors and nurses. Through hands-on demonstrations and video explanations, the structure, function, usage methods, and precautions of the Wanxiang Stop auxiliary uterine lifting support were introduced. ② During the operation, the surgeon used the Wanxiang Stop auxiliary uterine lifting support throughout the process for uterine lifting operations. And according to the surgical requirements, adjustments were made and the surgical field was exposed.
干预措施: a Universal Self-Locking Uterine Manipulator Stand (Device)
Manual uterine manipulation
The control group underwent the procedure with the surgical assistant using traditional manual uterine lifting techniques throughout. The surgical field was adjusted and exposed according to the surgical requirements.
结局指标
主要结局
Postoperative Fatigue
时间窗: At the end of surgery, prior to transfer to the recovery room.
Fatigue was assessed using the Borg Rating of Perceived Exertion (RPE) scale, a 6-to-20 point subjective scale. A score of 6 indicates no exertion and 20 indicates maximal exertion. Higher scores represent greater perceived physical fatigue.
次要结局
- Intraoperative Leg Abduction Angle(Intraoperatively)
- Total Surgery Duration(Intraoperatively)
- Incidence of Adverse Events(Intraoperative and up to 30 days post-surgery)
- Surgeon Satisfaction with Surgical Field Exposure(Within 30 minutes post-surgery)
- Intraoperative Blood Loss(Intraoperatively)
- Vaginal Wall Rotation and Resection Time(Intraoperatively)