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

NCT07445880 | Completed

• 1 other identifier: IRB-20230141-R
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hysterectomy

Keywords

Laparoscopic hysterectomy; Uterine manipulator

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Surgeon Satisfaction with Surgical Field Exposure

  Within 30 minutes post-surgery

• Intraoperative Blood Loss

  Intraoperatively

• Intraoperative Leg Abduction Angle

  Intraoperatively

• Total Surgery Duration

  Intraoperatively

• Vaginal Wall Rotation and Resection Time

  Intraoperatively

Other Outcomes (1)

• Operator Satisfaction with Procedure Convenience

  Within 30 minutes post-surgery

Study Arms (2)

Universal self-locking uterine manipulator stand

EXPERIMENTAL

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

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.

Interventions

a Universal Self-Locking Uterine Manipulator Stand DEVICE

To perform uterine manipulation with a Universal Self-Locking Uterine Manipulator Stand during total hysterectomy.

Universal self-locking uterine manipulator stand

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In this study, a single-blinded design was employed where the enrolled patients were blinded, while the operating surgeons could not be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: March 3, 2026
• Study Start: May 1, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)