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

China-Japan Friendship Hospital

Status: Enrolling

Conditions: Uterine Myoma; Surgery, Laparoscopic

Treatments: Device: Vnotes surgery using fully visualised surgical instruments; Device: Vnotes surgery using traditional surgical instruments

Study type: Interventional

Funder types: Other

Identifiers

NCT06658145

NTCS-vnotesLH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: Female

Ages: Under 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

Full visibility vnotes group

Experimental group

Description:

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.

Treatment:

Device: Vnotes surgery using fully visualised surgical instruments

Traditional vnotes group

Experimental group

Description:

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

Treatment:

Device: Vnotes surgery using traditional surgical instruments