Safety and Efficacy of Using a Novel Full Visual Access Platform System in Transvaginal Hysterectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vnotes surgery using fully visualised surgical instruments, Vnotes surgery using traditional surgical instruments.
- Who it may be relevant to
- Registry conditions: Uterine Myoma, Surgery, Laparoscopic. Basic parameters: up to 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Establishment and Clinical Study of the Whole Visual VNOTES Approach Platform
Overview
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.
Interventions
- Device Vnotes surgery using fully visualised surgical instruments
Vnotes surgery using fully visualised surgical instruments - Device Vnotes surgery using traditional surgical instruments
Vnotes surgery using traditional surgical instruments
Primary outcome measures
- Success rate of access platform establishment [Time frame: End of surgery]
Secondary outcome measures (12)
- Tightness of equipment [Time frame: End of surgery]
- Stability of equipment [Time frame: End of surgery]
- Controllability of equipment [Time frame: End of surgery]
- Time of establishment of the access platform [Time frame: End of surgery]
- Total time of surgery [Time frame: End of surgery]
- Total surgical bleeding volume [Time frame: End of surgery]
- The amount of bleeding during the process of establishing the platform [Time frame: End of surgery]
- Surgical complications [Time frame: 6 months after surgery]
- Length of hospital stay [Time frame: 6 months after surgery]
- Pain VAS score [Time frame: 6 months after surgery]
- The Patients' life quality postoperative [Time frame: 6 months after surgery]
- Heart rate during surgery [Time frame: End of surgery]
Eligibility criteria
Inclusion criteria
- Female patients ≤ 60years old
- Patients requiring total hysterectomy (with or without bilateral adjuncts or salpingectomy) due to uterine fibroids
- BMI ranges from 18.5 to 27.9kg/m2;
- Informed consent signed by the subject himself or his legal representative.
Exclusion criteria
- Pregnant and lactating women;
- asexual life history, vaginal malformations or adhesions, postmenopausal vaginal atrophy and stenosis;
- Preoperative examination for malignant possibility
- 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;
- Patients known to have severe hepatic or renal dysfunction;
- Patients with known blood disorders, coagulation disorders, active bleeding at any site, or bleeding propensity;
- 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;
- patients with acute infection;
- Known to have participated in any other clinical trial or taken hormone therapy within 3 months;
- who cannot sign the informed consent;
- For those with known or suspected poor compliance who could not complete the trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT06658145 · NTCS-vnotesLH