Actively Recruiting
The Establishment and Clinical Study of the Whole Visual VNOTES Approach Platform for Transvaginal Hysterectomy
Led by China-Japan Friendship Hospital · Updated on 2025-02-12
94
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new technique for hysterectomy called the vNOTES method in patients with uterine fibroids who need total hysterectomy. This study compares a new fully visualized vaginal access platform with the traditional vNOTES approach to assess if the new method is effective and safe. The trial is conducted as a multicenter, prospective randomized controlled study to carefully measure surgical outcomes and patient recovery. Participants are randomly assigned to either the experimental group using the multi-channel vaginal sealing instrument with full visualization or the control group using the traditional method. The new platform is inserted through the vagina, inflates with air pressure to expose the vaginal dome fully, and completes the hysterectomy under laparoscopic guidance. The traditional approach involves incising the vaginal fornix and part of cervical ligaments to establish the surgical platform. During the study, researchers will record the success of establishing the surgical platform, time taken, bleeding amounts, anesthesia indicators, and surgical complications. Follow-up includes measuring hospital stay length, pain scores, and quality of life for six months post-surgery. Vital signs like heart rate and blood pressure are monitored during surgery. The study aims to provide detailed safety and efficacy data over the entire surgical and recovery period.
CONDITIONS
Brief Title
Safety and Efficacy of Using a Novel Full Visual Access Platform System in Transvaginal Hysterectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients 60 years old or younger
- Patients requiring total hysterectomy due to uterine fibroids, with or without bilateral adjuncts or salpingectomy
- Body mass index (BMI) between 18.5 and 27.9 kg/m2
- Signed informed consent by the patient or legal representative
You will not qualify if you...
- Pregnant or breastfeeding women
- History of asexual life, vaginal malformations or adhesions, postmenopausal vaginal atrophy or stenosis
- Suspicion or evidence of malignancy on preoperative examination
- Uterine volume greater than or equal to 20 weeks, history of pelvic inflammatory disease, severe endometriosis, or advanced uterine prolapse
- Previous surgeries for intestinal obstruction, recurrent pelvic inflammatory disease, pelvic tuberculosis, or pelvic abdominal tumors
- Completely closed uterine and rectal fossa on gynecological examination
- Severe liver or kidney dysfunction
- Known blood or coagulation disorders, active bleeding or bleeding tendency
- Serious diseases affecting central nervous, cardiovascular, liver, kidney, digestive, respiratory, endocrine, skeletal, muscular, or mental health
- Acute infection
- Participation in another clinical trial or hormone therapy within the last 3 months
- Unable to provide informed consent
- Known or suspected poor compliance with trial requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo transvaginal hysterectomy using either fully visualised or traditional surgical instruments. The surgical operation includes establishing the access platform and completing the hysterectomy.
1 surgical visit (in-person)
Duration - 6 months
Participants are monitored for surgical complications, pain, and quality of life for up to 6 months after surgery.
Approximately 3 to 4 follow-up visits over 6 months
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 086010
Actively Recruiting
Research Team
J
Jing Liang, MD
Y
Yuebo Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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