Clinical Application and Efficacy of a Self-Locking Uterine Manipulator Stand in Hysterectomy

Effectiveness of a Universal Self-Locking Uterine Manipulator Stand in Hysterectomy：a Single-center,Single-blind, Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Hysterectomy
• Intervention / Treatment: Device: a Universal Self-Locking Uterine Manipulator Stand

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Women's Hospital School of Medicine Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: a Universal Self-Locking Uterine Manipulator Stand; To perform uterine manipulation with a Universal Self-Locking Uterine Manipulator Stand during total hysterectomy.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Laparoscopic hysterectomy; Uterine manipulator
• Other Study ID Numbers: IRB-20230141-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No