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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Universal self-locking uterine manipulator stand | Experimental | The intervention in the experimental group included: â‘ 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. â‘¡ 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. |
|
| Manual uterine manipulation | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a Universal Self-Locking Uterine Manipulator Stand | Device | To perform uterine manipulation with a Universal Self-Locking Uterine Manipulator Stand during total hysterectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Fatigue | 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. | At the end of surgery, prior to transfer to the recovery room. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon Satisfaction with Surgical Field Exposure | Surgeon satisfaction was assessed using a self-developed 5-point Likert scale. The scale evaluated the clarity of the surgical field exposure, with response options ranging from "very unsatisfied" to "very satisfied". Scores range from 1 to 5, with higher scores indicating greater satisfaction. | Within 30 minutes post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operator Satisfaction with Procedure Convenience | Operator satisfaction was assessed using a self-developed 5-point Likert scale. Operators evaluated the convenience of the hysterectomy procedure based on their experience, with response options ranging from "very dissatisfied" to "very satisfied". Scores range from 1 to 5, with higher scores indicating greater satisfaction. | Within 30 minutes post-surgery |
Inclusion Criteria:
Medical Staff:
Surgical Patients:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital School Of Medicine Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
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In this study, a single-blinded design was employed where the enrolled patients were blinded, while the operating surgeons could not be blinded.
| Intraoperative Blood Loss | Blood loss during surgery, measured in milliliters (mL). | Intraoperatively |
| Intraoperative Leg Abduction Angle | The maximum angle of leg abduction during surgery, measured in degrees. | Intraoperatively |
| Total Surgery Duration | Time from skin incision to wound closure, measured in minutes. | Intraoperatively |
| Vaginal Wall Rotation and Resection Time | Time required for vaginal wall rotation and resection, measured in minutes. | Intraoperatively |
| Incidence of Adverse Events | Any intraoperative or postoperative adverse events. | Intraoperative and up to 30 days post-surgery |