Evaluating a new surgical platform for hysterectomy

The Establishment and Clinical Study of the Whole Visual VNOTES Approach Platform

This study is testing a new surgical system for performing hysterectomies to see if it is safer and more effective than the traditional method for patients with uterine fibroids.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: N/A to 60 Years
• Sex: Female
• Sponsor: China-Japan Friendship Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06658145 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety and efficacy of a novel full visual access platform system in performing transvaginal hysterectomies for patients with uterine fibroids. It is a multi-center, prospective randomized controlled trial where participants are assigned to either the experimental vNOTES group or the traditional laparoscopic group. Key metrics such as surgical time, bleeding, anesthesia indicators, and complications are recorded to evaluate the effectiveness of the new technique compared to traditional methods.

Who should consider this trial

Good fit: Ideal candidates are women under 60 years old requiring a total hysterectomy due to uterine fibroids.

Not a fit: Patients who are pregnant, have certain vaginal conditions, or severe health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to safer and more efficient hysterectomy procedures for patients with uterine fibroids.

How similar studies have performed: Other studies have shown promising results with similar minimally invasive surgical techniques, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Female patients ≤ 60years old
2. Patients requiring total hysterectomy (with or without bilateral adjuncts or salpingectomy) due to uterine fibroids
3. BMI ranges from 18.5 to 27.9kg/m2;
4. Informed consent signed by the subject himself or his legal representative.

Exclusion Criteria:

1. Pregnant and lactating women;
2. asexual life history, vaginal malformations or adhesions, postmenopausal vaginal atrophy and stenosis;
3. Preoperative examination for malignant possibility
4. Uterine volume ≥20 weeks, history of pelvic inflammatory disease, severe endometriosis, degree III or IV uterine prolapse; Previous surgical history of intestinal obstruction, recurrent pelvic inflammatory disease, pelvic tuberculosis, and pelvic abdominal tumor; Gynecological examination of the uterine and rectal fossa is completely closed;
5. Patients known to have severe hepatic or renal dysfunction;
6. Patients with known blood disorders, coagulation disorders, active bleeding at any site, or bleeding propensity;
7. complicated with serious diseases of central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine and metabolism (thyroid disease, Cushing\'s syndrome, hyperprolactinemia), skeletal and muscular system and mental disorders;
8. patients with acute infection;
9. Known to have participated in any other clinical trial or taken hormone therapy within 3 months;
10. who cannot sign the informed consent;
11. For those with known or suspected poor compliance who could not complete the trial.

Where this trial is running

Beijing, Beijing Municipality

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jing Liang, MD — China-Japan Friendship Hospital
• Study coordinator: Jing Liang, MD

Conditions Uterine Myoma; Surgery, Laparoscopic