Clinical Application and Efficacy of a Self-Locking Uterine Manipulator Stand in Hysterectomy (NCT07445880) | Clinical Trial Compass
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 range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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