CompletedNot Applicable

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

China100 participantsStarted 2023-05-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexFEMALE

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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

What they're measuring

Postoperative Fatigue

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

Trial details

NCT IDNCT07445880

SponsorWomen's Hospital School Of Medicine Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-12