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CompletedNCT07445880Updated Mar 3, 2026

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

An interventional study of a Universal Self-Locking Uterine Manipulator Stand in Hysterectomy, sponsored by Women's Hospital School Of Medicine Zhejiang University. Completed at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Women's Hospital School Of Medicine Zhejiang University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled May 2023, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.
02

Conditions studied

  • Hysterectomy

Keywords

  • Laparoscopic hysterectomy
  • Uterine manipulator
03

In context

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 74 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • Devicea Universal Self-Locking Uterine Manipulator Stand

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

06

What researchers measure

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.

    Time frame: At the end of surgery, prior to transfer to the recovery room.

Secondary outcomes

  1. 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.

    Time frame: Within 30 minutes post-surgery

  2. Intraoperative Blood Loss

    Blood loss during surgery, measured in milliliters (mL).

    Time frame: Intraoperatively

  3. Intraoperative Leg Abduction Angle

    The maximum angle of leg abduction during surgery, measured in degrees.

    Time frame: Intraoperatively

  4. Total Surgery Duration

    Time from skin incision to wound closure, measured in minutes.

    Time frame: Intraoperatively

  5. Vaginal Wall Rotation and Resection Time

    Time required for vaginal wall rotation and resection, measured in minutes.

    Time frame: Intraoperatively

  6. Incidence of Adverse Events

    Any intraoperative or postoperative adverse events.

    Time frame: Intraoperative and up to 30 days post-surgery

Other outcomes

  1. 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.

    Time frame: Within 30 minutes post-surgery

07

Study locations

1 site
  • Women's Hospital School Of Medicine Zhejiang University
    Hangzhou, Zhejiang 310000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07445880
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Responsible party
Sponsor
First posted
Mar 3, 2026
Start date
May 1, 2023
Primary completion
Dec 12, 2023
Completion
Dec 12, 2023
Last update
Mar 3, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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