Surgery, Laparoscopic, Uterine Myoma
Conditions
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.
Interventions
DEVICEVnotes surgery using fully visualised surgical instruments
Vnotes surgery using fully visualised surgical instruments
DEVICEVnotes surgery using traditional surgical instruments
Vnotes surgery using traditional surgical instruments
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Tightness of equipment | End of surgery | Throughout the operation, whether the device can remain airtight |
| Length of hospital stay | 6 months after surgery | The time from admission to discharge |
| 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. |
| Heart rate during surgery | End of surgery | The magnitude of the change in the surgical center rate |
| blood pressure during surgery | End of surgery | The magnitude of the change in blood pressure during surgery |
| Surgical complications | 6 months after surgery | Whether there was fever, infection and organ damage after operation |
Countries
China
Contacts
Primary ContactJing Liang, MD
Backup ContactYuebo Li, MD
Outcome results
None listed