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Completed

NCT Number: NCT07445880

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

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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Key information

Conditions

Hysterectomy

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

a Universal Self-Locking Uterine Manipulator Stand

Device

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

Primary outcomes

  1. Postoperative Fatigue

    Time frame: 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 outcomes

  1. Surgeon Satisfaction with Surgical Field Exposure

    Time frame: 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.

  2. Intraoperative Blood Loss

    Time frame: Intraoperatively

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

  3. Intraoperative Leg Abduction Angle

    Time frame: Intraoperatively

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

  4. Total Surgery Duration

    Time frame: Intraoperatively

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

  5. Vaginal Wall Rotation and Resection Time

    Time frame: Intraoperatively

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

  6. Incidence of Adverse Events

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

    Any intraoperative or postoperative adverse events.

Other outcomes

  1. Operator Satisfaction with Procedure Convenience

    Time frame: Within 30 minutes post-surgery

    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.

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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