Hysterectomy
Conditions
Keywords
Laparoscopic hysterectomy, Uterine manipulator
Brief summary
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.
Interventions
DEVICEa Universal Self-Locking Uterine Manipulator Stand
To perform uterine manipulation with a Universal Self-Locking Uterine Manipulator Stand during total hysterectomy.
Sponsors
Women's Hospital School Of Medicine Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In this study, a single-blinded design was employed where the enrolled patients were blinded, while the operating surgeons could not be blinded.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Fatigue | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Satisfaction with Surgical Field Exposure | Within 30 minutes post-surgery | 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. |
| Intraoperative Blood Loss | Intraoperatively | Blood loss during surgery, measured in milliliters (mL). |
| Intraoperative Leg Abduction Angle | Intraoperatively | The maximum angle of leg abduction during surgery, measured in degrees. |
| Total Surgery Duration | Intraoperatively | Time from skin incision to wound closure, measured in minutes. |
| Vaginal Wall Rotation and Resection Time | Intraoperatively | Time required for vaginal wall rotation and resection, measured in minutes. |
| Incidence of Adverse Events | Intraoperative and up to 30 days post-surgery | Any intraoperative or postoperative adverse events. |
Countries
China
Outcome results
None listed