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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full visibility vnotes group | Experimental | 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. |
|
| Traditional vnotes group | Experimental | The vaginal fornix and part of cervical ligaments were incised by vaginal operation, and an approach platform was established to complete hysterectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vnotes surgery using fully visualised surgical instruments | Device | Vnotes surgery using fully visualised surgical instruments |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Liang, MD | Contact | 8684206115 | jacyliang@sina.com | |
| Yuebo Li, MD | Contact | 8684206115 | yueboli@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Liang, MD | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 086010 | China |
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| Vnotes surgery using traditional surgical instruments | Device | Vnotes surgery using traditional surgical instruments |
|
| 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 |
| Length of hospital stay | The time from admission to discharge | 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 |
| 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 |
| ID | Term |
|---|---|
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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