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

Not Applicable

Recruiting

• Conditions: Uterine Myoma; Surgery, Laparoscopic; Uterine Myoma; Surgery, Laparoscopic

• Registration Number: NCT06658145
• Lead Sponsor: China-Japan Friendship Hospital

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.

Study Timeline

• Study First Submitted: 2024-09-10
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-26
• Study Start: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-12-31
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Success rate of access platform establishment	End of surgery	Success is defined as opening the vaginal vault and entering the abdominal cavity to create stable abdominal pressure

Secondary Outcome Measures

Name	Time	Method
Tightness of equipment	End of surgery	Throughout the operation, whether the device can remain airtight
Stability of equipment	End of surgery	Throughout the operation, whether the equipment is tilted or slipped
Controllability of equipment	End of surgery	Throughout the operation, whether the equipment can be smoothly inserted, extended, conformed, and advanced
Time of establishment of the access platform	End of surgery	The time from the start of the procedure to the establishment of vaginal access
Total time of surgery	End of surgery	The time from the beginning of the procedure to its complete completion
Total surgical bleeding volume	End of surgery	Total blood loss from the beginning to the end of the procedure
The amount of bleeding during the process of establishing the platform	End of surgery	The amount of bleeding from the beginning of surgery until the establishment of vaginal access
Surgical complications	6 months after surgery	Whether there was fever, infection and organ damage after operation
Length of hospital stay	6 months after surgery	The time from admission to discharge
Heart rate during surgery	End of surgery	The magnitude of the change in the surgical center rate
Pain VAS score	6 months after surgery	Pain scores during postoperative hospital stay and follow-up（The Visual Analogue Scale (VAS) is a widely used method for pain assessment. 0 represents "no pain" and 10 represents "most severe pain".）
The Patients' life quality postoperative	6 months after surgery	The Patients' life quality postoperative be measured by Questionnaire.
blood pressure during surgery	End of surgery	The magnitude of the change in blood pressure during surgery

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China