HysterectomyNCT07445880
Clinical Application and Efficacy of a Self-Locking Uterine Manipulator Stand in Hysterectomy
A study testing a Universal Self-Locking Uterine Manipulator Stand in people with Hysterectomy, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- a Universal Self-Locking Uterine Manipulator Stand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- Age 18 to 75 years
- Undergoing tracheal intubation general anesthesia
- No contraindications for uterine manipulation
- Willing to participate voluntarily and provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Effectiveness of a Universal Self-Locking Uterine Manipulator Stand in Hysterectomy：a Single-center,Single-blind, Randomized Controlled Study
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
- Being tested
- a Universal Self-Locking Uterine Manipulator Stand
- Keywords
- Laparoscopic hysterectomy, Uterine manipulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a Universal Self-Locking Uterine Manipulator StandDevice
To perform uterine manipulation with a Universal Self-Locking Uterine Manipulator Stand during total hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of surgery, prior to transfer to the recovery room.
Secondary outcomes (6)
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.
Measured: Within 30 minutes post-surgery
Intraoperative Blood Loss
Blood loss during surgery, measured in milliliters (mL).
Measured: Intraoperatively
Intraoperative Leg Abduction Angle
The maximum angle of leg abduction during surgery, measured in degrees.
Measured: Intraoperatively
Total Surgery Duration
Time from skin incision to wound closure, measured in minutes.
Measured: Intraoperatively
Vaginal Wall Rotation and Resection Time
Time required for vaginal wall rotation and resection, measured in minutes.
Measured: Intraoperatively
Incidence of Adverse Events
Any intraoperative or postoperative adverse events.
Measured: Intraoperative and up to 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 May 2023
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445880
- Sponsor's protocol ID
- IRB-20230141-R
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Universal Self-Locking Uterine Manipulator Stand in Hysterectomy：a Single-center,Single-blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07445880
- Acronym / sponsor ID
- IRB-20230141-R
- Conditions
- Hysterectomy
- Keywords
- Laparoscopic hysterectomy, Uterine manipulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Universal self-locking uterine manipulator stand | Experimental | Device: a Universal Self-Locking Uterine Manipulator StandThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Age 18 to 75 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a Universal Self-Locking Uterine Manipulator StandTo perform uterine manipulation with a Universal Self-Locking Uterine Manipulator Stand during total hysterectomy. | Device | Universal self-locking uterine manipulator stand |
Primary outcome
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.
6 secondary outcomes
Surgeon Satisfaction with Surgical Field Exposure
Time frame: Within 30 minutes post-surgery
Intraoperative Blood Loss
Time frame: Intraoperatively
Intraoperative Leg Abduction Angle
Time frame: Intraoperatively
Total Surgery Duration
Time frame: Intraoperatively
Vaginal Wall Rotation and Resection Time
Time frame: Intraoperatively
Incidence of Adverse Events
Time frame: Intraoperative and up to 30 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a Universal Self-Locking Uterine Manipulator Stand in people with Hysterectomy, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Fatigue (time frame: At the end of surgery, prior to transfer to the recovery room.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.