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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Uterine Myoma; Surgery, Laparoscopic
• Intervention / Treatment: Device: Vnotes surgery using fully visualised surgical instruments; Device: Vnotes surgery using traditional surgical instruments

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 Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Liang, MD; Phone Number: 8684206115; Email: jacyliang@sina.com
• Study Contact Backup: Name: Yuebo Li, MD; Phone Number: 8684206115; Email: yueboli@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 086010
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Fang Zhao, MD; Phone Number: +86-010-84206115; Email: jacyliang@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Vnotes surgery using fully visualised surgical instruments; Vnotes surgery using fully visualised surgical instruments
Experimental: 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.	Device: Vnotes surgery using traditional surgical instruments; Vnotes surgery using traditional surgical instruments

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tightness of equipment	Throughout the operation, whether the device can remain airtight	End of surgery
Stability of equipment	Throughout the operation, whether the equipment is tilted or slipped	End of surgery
Controllability of equipment	Throughout the operation, whether the equipment can be smoothly inserted, extended, conformed, and advanced	End of surgery
Time of establishment of the access platform	The time from the start of the procedure to the establishment of vaginal access	End of surgery
Total time of surgery	The time from the beginning of the procedure to its complete completion	End of surgery
Total surgical bleeding volume	Total blood loss from the beginning to the end of the procedure	End of surgery
The amount of bleeding during the process of establishing the platform	The amount of bleeding from the beginning of surgery until the establishment of vaginal access	End of surgery
Surgical complications	Whether there was fever, infection and organ damage after operation	6 months after surgery
Pain VAS score	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".）	6 months after surgery
The Patients' life quality postoperative	The Patients' life quality postoperative be measured by Questionnaire.	6 months after surgery
Length of hospital stay	The time from admission to discharge	6 months after surgery
Heart rate during surgery	The magnitude of the change in the surgical center rate	End of surgery
blood pressure during surgery	The magnitude of the change in blood pressure during surgery	End of surgery

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Principal Investigator: Jing Liang, MD, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: NTCS-vnotesLH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No