Safety and Efficacy of Using a Novel Full Visual Access Platform System in Transvaginal Hysterectomy

NCT ID: NCT06658145

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2027-06-30

Brief Summary

The modified vNOTES hysterectomy was accomplished and validated for efficacy and safety using a multi-access vaginal confinement instrument with a fully visualised vaginal access platform.

Detailed Description

A multi-center prospective randomized controlled trial was conducted to evaluate the efficacy and safety of the vNOTES technique in patients with uterine fibroids who were scheduled for total hysterectomy. The patients were randomly assigned to the vNOTES group (experimental group) and the traditional vNOTES group (control group). The access platform was established using a visualization method or the traditional laparoscopic method, and the surgical operation was completed. The time required to establish the platform, the amount of bleeding, the total surgical time, the anesthesia indicators, complications, and follow-up indicators were recorded, and the effectiveness and safety of the technique were evaluated.

Conditions

Uterine Myoma; Surgery, Laparoscopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Full visibility vnotes group

A suitable size of multi-channel vaginal sealing instrument was inserted from the vagina, pneumoperitoneum formed air pressure, and the vaginal dome was dilated and fully exposed. The dome was opened under laparoscopy, and an approach platform was established to complete the total hysterectomy.

Group Type: EXPERIMENTAL

Vnotes surgery using fully visualised surgical instruments

Intervention Type: DEVICE

Vnotes surgery using fully visualised surgical instruments

Traditional vnotes group

The vaginal fornix and part of cervical ligaments were incised by vaginal operation, and an approach platform was established to complete hysterectomy.

Group Type: EXPERIMENTAL

Vnotes surgery using traditional surgical instruments

Intervention Type: DEVICE

Vnotes surgery using traditional surgical instruments

Interventions

Vnotes surgery using fully visualised surgical instruments

Vnotes surgery using fully visualised surgical instruments

Intervention Type: DEVICE

Vnotes surgery using traditional surgical instruments

Vnotes surgery using traditional surgical instruments

Intervention Type: DEVICE

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.

• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jing Liang

Director of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Liang, MD

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Liang, MD

Role: CONTACT

jacyliang@sina.com

8684206115

Yuebo Li, MD

Role: CONTACT

yueboli@126.com

8684206115

Facility Contacts

Fang Zhao, MD

Role: primary

jacyliang@sina.com

+86-010-84206115

Other Identifiers

NTCS-vnotesLH

Identifier Type: -

Identifier Source: org_study_id