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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
Vnotes surgery using fully visualised surgical instruments
Vnotes surgery using traditional surgical instruments
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGSuccess rate of access platform establishment
Success is defined as opening the vaginal vault and entering the abdominal cavity to create stable abdominal pressure
Time frame: End of surgery
Tightness of equipment
Throughout the operation, whether the device can remain airtight
Time frame: End of surgery
Stability of equipment
Throughout the operation, whether the equipment is tilted or slipped
Time frame: End of surgery
Controllability of equipment
Throughout the operation, whether the equipment can be smoothly inserted, extended, conformed, and advanced
Time frame: End of surgery
Time of establishment of the access platform
The time from the start of the procedure to the establishment of vaginal access
Time frame: End of surgery
Total time of surgery
The time from the beginning of the procedure to its complete completion
Time frame: End of surgery
Total surgical bleeding volume
Total blood loss from the beginning to the end of the procedure
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: End of surgery
Surgical complications
Whether there was fever, infection and organ damage after operation
Time frame: 6 months after surgery
Length of hospital stay
The time from admission to discharge
Time frame: 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".)
Time frame: 6 months after surgery
The Patients' life quality postoperative
The Patients' life quality postoperative be measured by Questionnaire.
Time frame: 6 months after surgery
Heart rate during surgery
The magnitude of the change in the surgical center rate
Time frame: End of surgery
blood pressure during surgery
The magnitude of the change in blood pressure during surgery
Time frame: End of surgery